CLAIMBOUND / SOURCE-PUBLICATION EVIDENCE
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Every card identifies what it proves, what it does not prove, its exact quote, locator, source hash, and local rerun command.
1. WHO Regulation and Prequalification Department Annual Report 2025 · PDF page 8
Narrow public claim
The Department of Regulation and Prequalification will continue to leverage the critical contributions of scientific and technical expertise and resources from extensive networks, advisor groups and task forces and build on the successful platform of the WHO Coalition of Interested Parties, now counting 33 partners.
What this card proves
The exact quoted statement occurred in the named official PDF fetched on 2026-08-17, and the complete PDF matched the recorded SHA-256.
What this card does not prove
It does not independently establish the underlying model capability, safety, comparison, or real-world truth. This is a retrospective single-maintainer source-publication audit.
- Primary source
- WHO Regulation and Prequalification Department Annual Report 2025
- Section locator
PDF page 8- Captured
- 2026-08-17
- Source SHA-256
489f48ce81a7d8294ced574a7dad00a821de912b07cdb81437386854708895c3- Reproduction
- Maintainer run only; no independent operator rerun is registered.
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The Department of Regulation and Prequalification will continue to leverage the critical contributions of scientific and technical expertise and resources from extensive networks, advisor groups and task forces and build on the successful platform of the WHO Coalition of Interested Parties, now counting 33 partners.
2. WHO Regulation and Prequalification Department Annual Report 2025 · PDF page 12
Narrow public claim
The plan supports coherent implementation across WHO while aligning closely with the strategies and operational needs of its main partners, or major global health actors.
What this card proves
The exact quoted statement occurred in the named official PDF fetched on 2026-08-17, and the complete PDF matched the recorded SHA-256.
What this card does not prove
It does not independently establish the underlying model capability, safety, comparison, or real-world truth. This is a retrospective single-maintainer source-publication audit.
- Primary source
- WHO Regulation and Prequalification Department Annual Report 2025
- Section locator
PDF page 12- Captured
- 2026-08-17
- Source SHA-256
489f48ce81a7d8294ced574a7dad00a821de912b07cdb81437386854708895c3- Reproduction
- Maintainer run only; no independent operator rerun is registered.
Repeat this exact check locally
Download the PDF to a local file, then run the committed verifier. A changed PDF is reported as drift rather than silently accepted.
python scripts/verify_primary_public_claim_group.py artifacts/cb7k_dom021_t01_primary_claims.json --source-file <local-raw-pdf>Exact source quote
The plan supports coherent implementation across WHO while aligning closely with the strategies and operational needs of its main partners, or major global health actors.
3. WHO Regulation and Prequalification Department Annual Report 2025 · PDF page 12
Narrow public claim
The mandate of the Department of Regulation and Prequalification and the Strategic Action Plan 2025–2028 support a long-term transition from prequalification towards functional national and regional regulatory capacities, through a process of regulatory system strengthening, harmonization, reliance, convergence and networking.
What this card proves
The exact quoted statement occurred in the named official PDF fetched on 2026-08-17, and the complete PDF matched the recorded SHA-256.
What this card does not prove
It does not independently establish the underlying model capability, safety, comparison, or real-world truth. This is a retrospective single-maintainer source-publication audit.
- Primary source
- WHO Regulation and Prequalification Department Annual Report 2025
- Section locator
PDF page 12- Captured
- 2026-08-17
- Source SHA-256
489f48ce81a7d8294ced574a7dad00a821de912b07cdb81437386854708895c3- Reproduction
- Maintainer run only; no independent operator rerun is registered.
Repeat this exact check locally
Download the PDF to a local file, then run the committed verifier. A changed PDF is reported as drift rather than silently accepted.
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The mandate of the Department of Regulation and Prequalification and the Strategic Action Plan 2025–2028 support a long-term transition from prequalification towards functional national and regional regulatory capacities, through a process of regulatory system strengthening, harmonization, reliance, convergence and networking.
4. WHO Regulation and Prequalification Department Annual Report 2025 · PDF page 16
Narrow public claim
WHO’s independent prequalification and risk-based assessment functions help to reduce procurement risk, strengthen confidence in supply chains and support informed purchasing decisions and overall maximize the health impact and value for money of global health financing.
What this card proves
The exact quoted statement occurred in the named official PDF fetched on 2026-08-17, and the complete PDF matched the recorded SHA-256.
What this card does not prove
It does not independently establish the underlying model capability, safety, comparison, or real-world truth. This is a retrospective single-maintainer source-publication audit.
- Primary source
- WHO Regulation and Prequalification Department Annual Report 2025
- Section locator
PDF page 16- Captured
- 2026-08-17
- Source SHA-256
489f48ce81a7d8294ced574a7dad00a821de912b07cdb81437386854708895c3- Reproduction
- Maintainer run only; no independent operator rerun is registered.
Repeat this exact check locally
Download the PDF to a local file, then run the committed verifier. A changed PDF is reported as drift rather than silently accepted.
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WHO’s independent prequalification and risk-based assessment functions help to reduce procurement risk, strengthen confidence in supply chains and support informed purchasing decisions and overall maximize the health impact and value for money of global health financing.
5. WHO Regulation and Prequalification Department Annual Report 2025 · PDF page 17
Narrow public claim
These Joint WHO-UNICEF-UNFPA meetings have served as an important platform for collaboration and updates and discussion on crucial topics since 2012.
What this card proves
The exact quoted statement occurred in the named official PDF fetched on 2026-08-17, and the complete PDF matched the recorded SHA-256.
What this card does not prove
It does not independently establish the underlying model capability, safety, comparison, or real-world truth. This is a retrospective single-maintainer source-publication audit.
- Primary source
- WHO Regulation and Prequalification Department Annual Report 2025
- Section locator
PDF page 17- Captured
- 2026-08-17
- Source SHA-256
489f48ce81a7d8294ced574a7dad00a821de912b07cdb81437386854708895c3- Reproduction
- Maintainer run only; no independent operator rerun is registered.
Repeat this exact check locally
Download the PDF to a local file, then run the committed verifier. A changed PDF is reported as drift rather than silently accepted.
python scripts/verify_primary_public_claim_group.py artifacts/cb7k_dom021_t01_primary_claims.json --source-file <local-raw-pdf>Exact source quote
These Joint WHO-UNICEF-UNFPA meetings have served as an important platform for collaboration and updates and discussion on crucial topics since 2012.
6. WHO Regulation and Prequalification Department Annual Report 2025 · PDF page 17
Narrow public claim
WHO’s ground-breaking risk-benefit assessment for snake antivenoms used in the treatment of snakebite envenoming provides evidence of efficacy and safety for products used in high-risk communities across the African Region, Eastern Mediterranean Region and South-East Asia Region.
What this card proves
The exact quoted statement occurred in the named official PDF fetched on 2026-08-17, and the complete PDF matched the recorded SHA-256.
What this card does not prove
It does not independently establish the underlying model capability, safety, comparison, or real-world truth. This is a retrospective single-maintainer source-publication audit.
- Primary source
- WHO Regulation and Prequalification Department Annual Report 2025
- Section locator
PDF page 17- Captured
- 2026-08-17
- Source SHA-256
489f48ce81a7d8294ced574a7dad00a821de912b07cdb81437386854708895c3- Reproduction
- Maintainer run only; no independent operator rerun is registered.
Repeat this exact check locally
Download the PDF to a local file, then run the committed verifier. A changed PDF is reported as drift rather than silently accepted.
python scripts/verify_primary_public_claim_group.py artifacts/cb7k_dom021_t01_primary_claims.json --source-file <local-raw-pdf>Exact source quote
WHO’s ground-breaking risk-benefit assessment for snake antivenoms used in the treatment of snakebite envenoming provides evidence of efficacy and safety for products used in high-risk communities across the African Region, Eastern Mediterranean Region and South-East Asia Region.
7. WHO Regulation and Prequalification Department Annual Report 2025 · PDF page 18
Narrow public claim
This record-setting performance includes multiple mpox assays, with the total number of Emergency Use Listing listed MPXV assays now reaching 12.
What this card proves
The exact quoted statement occurred in the named official PDF fetched on 2026-08-17, and the complete PDF matched the recorded SHA-256.
What this card does not prove
It does not independently establish the underlying model capability, safety, comparison, or real-world truth. This is a retrospective single-maintainer source-publication audit.
- Primary source
- WHO Regulation and Prequalification Department Annual Report 2025
- Section locator
PDF page 18- Captured
- 2026-08-17
- Source SHA-256
489f48ce81a7d8294ced574a7dad00a821de912b07cdb81437386854708895c3- Reproduction
- Maintainer run only; no independent operator rerun is registered.
Repeat this exact check locally
Download the PDF to a local file, then run the committed verifier. A changed PDF is reported as drift rather than silently accepted.
python scripts/verify_primary_public_claim_group.py artifacts/cb7k_dom021_t01_primary_claims.json --source-file <local-raw-pdf>Exact source quote
This record-setting performance includes multiple mpox assays, with the total number of Emergency Use Listing listed MPXV assays now reaching 12.
8. WHO Regulation and Prequalification Department Annual Report 2025 · PDF page 18
Narrow public claim
Through WHO prequalification and Emergency Use Listing, these products undergo rigorous quality assessment, which is critical for safeguarding public health, expanding access to essential diagnostics and supporting health systems in low- and middle-income countries.
What this card proves
The exact quoted statement occurred in the named official PDF fetched on 2026-08-17, and the complete PDF matched the recorded SHA-256.
What this card does not prove
It does not independently establish the underlying model capability, safety, comparison, or real-world truth. This is a retrospective single-maintainer source-publication audit.
- Primary source
- WHO Regulation and Prequalification Department Annual Report 2025
- Section locator
PDF page 18- Captured
- 2026-08-17
- Source SHA-256
489f48ce81a7d8294ced574a7dad00a821de912b07cdb81437386854708895c3- Reproduction
- Maintainer run only; no independent operator rerun is registered.
Repeat this exact check locally
Download the PDF to a local file, then run the committed verifier. A changed PDF is reported as drift rather than silently accepted.
python scripts/verify_primary_public_claim_group.py artifacts/cb7k_dom021_t01_primary_claims.json --source-file <local-raw-pdf>Exact source quote
Through WHO prequalification and Emergency Use Listing, these products undergo rigorous quality assessment, which is critical for safeguarding public health, expanding access to essential diagnostics and supporting health systems in low- and middle-income countries.
9. WHO Regulation and Prequalification Department Annual Report 2025 · PDF page 19
Narrow public claim
As of 2025, nearly 1750 medical products are either prequalified or recommended through Emergency Use Listing.
What this card proves
The exact quoted statement occurred in the named official PDF fetched on 2026-08-17, and the complete PDF matched the recorded SHA-256.
What this card does not prove
It does not independently establish the underlying model capability, safety, comparison, or real-world truth. This is a retrospective single-maintainer source-publication audit.
- Primary source
- WHO Regulation and Prequalification Department Annual Report 2025
- Section locator
PDF page 19- Captured
- 2026-08-17
- Source SHA-256
489f48ce81a7d8294ced574a7dad00a821de912b07cdb81437386854708895c3- Reproduction
- Maintainer run only; no independent operator rerun is registered.
Repeat this exact check locally
Download the PDF to a local file, then run the committed verifier. A changed PDF is reported as drift rather than silently accepted.
python scripts/verify_primary_public_claim_group.py artifacts/cb7k_dom021_t01_primary_claims.json --source-file <local-raw-pdf>Exact source quote
As of 2025, nearly 1750 medical products are either prequalified or recommended through Emergency Use Listing.
10. WHO Regulation and Prequalification Department Annual Report 2025 · PDF page 19
Narrow public claim
A hybrid assessment model (combining online inspection and desk-based assessment) was piloted to maintain continuity of oversight when on-site inspections were not feasible.
What this card proves
The exact quoted statement occurred in the named official PDF fetched on 2026-08-17, and the complete PDF matched the recorded SHA-256.
What this card does not prove
It does not independently establish the underlying model capability, safety, comparison, or real-world truth. This is a retrospective single-maintainer source-publication audit.
- Primary source
- WHO Regulation and Prequalification Department Annual Report 2025
- Section locator
PDF page 19- Captured
- 2026-08-17
- Source SHA-256
489f48ce81a7d8294ced574a7dad00a821de912b07cdb81437386854708895c3- Reproduction
- Maintainer run only; no independent operator rerun is registered.
Repeat this exact check locally
Download the PDF to a local file, then run the committed verifier. A changed PDF is reported as drift rather than silently accepted.
python scripts/verify_primary_public_claim_group.py artifacts/cb7k_dom021_t01_primary_claims.json --source-file <local-raw-pdf>Exact source quote
A hybrid assessment model (combining online inspection and desk-based assessment) was piloted to maintain continuity of oversight when on-site inspections were not feasible.
11. WHO Regulation and Prequalification Department Annual Report 2025 · PDF page 19
Narrow public claim
In addition, post-market surveillance activities – including the review of recalls, complaints, and reported quality defects – were used to identify potential systemic weaknesses, emerging trends, and areas requiring corrective and preventive action to strengthen ongoing compliance with good manufacturing practice of relevant manufacturers.
What this card proves
The exact quoted statement occurred in the named official PDF fetched on 2026-08-17, and the complete PDF matched the recorded SHA-256.
What this card does not prove
It does not independently establish the underlying model capability, safety, comparison, or real-world truth. This is a retrospective single-maintainer source-publication audit.
- Primary source
- WHO Regulation and Prequalification Department Annual Report 2025
- Section locator
PDF page 19- Captured
- 2026-08-17
- Source SHA-256
489f48ce81a7d8294ced574a7dad00a821de912b07cdb81437386854708895c3- Reproduction
- Maintainer run only; no independent operator rerun is registered.
Repeat this exact check locally
Download the PDF to a local file, then run the committed verifier. A changed PDF is reported as drift rather than silently accepted.
python scripts/verify_primary_public_claim_group.py artifacts/cb7k_dom021_t02_primary_claims.json --source-file <local-raw-pdf>Exact source quote
In addition, post-market surveillance activities – including the review of recalls, complaints, and reported quality defects – were used to identify potential systemic weaknesses, emerging trends, and areas requiring corrective and preventive action to strengthen ongoing compliance with good manufacturing practice of relevant manufacturers.
12. WHO Regulation and Prequalification Department Annual Report 2025 · PDF page 19
Narrow public claim
WHO prequalifies first maternal respiratory syncytial virus vaccine to protect infants WHO prequalified 9 vaccines in 2025, including the first respiratory syncytial virus vaccine, two additional polio vaccines (OPV and sIPV), and new vaccines for cholera, hepatitis B and pneumococcal disease, expanding the range of quality-assured vaccines available for use in low- and middle-income countries.
What this card proves
The exact quoted statement occurred in the named official PDF fetched on 2026-08-17, and the complete PDF matched the recorded SHA-256.
What this card does not prove
It does not independently establish the underlying model capability, safety, comparison, or real-world truth. This is a retrospective single-maintainer source-publication audit.
- Primary source
- WHO Regulation and Prequalification Department Annual Report 2025
- Section locator
PDF page 19- Captured
- 2026-08-17
- Source SHA-256
489f48ce81a7d8294ced574a7dad00a821de912b07cdb81437386854708895c3- Reproduction
- Maintainer run only; no independent operator rerun is registered.
Repeat this exact check locally
Download the PDF to a local file, then run the committed verifier. A changed PDF is reported as drift rather than silently accepted.
python scripts/verify_primary_public_claim_group.py artifacts/cb7k_dom021_t02_primary_claims.json --source-file <local-raw-pdf>Exact source quote
WHO prequalifies first maternal respiratory syncytial virus vaccine to protect infants WHO prequalified 9 vaccines in 2025, including the first respiratory syncytial virus vaccine, two additional polio vaccines (OPV and sIPV), and new vaccines for cholera, hepatitis B and pneumococcal disease, expanding the range of quality-assured vaccines available for use in low- and middle-income countries.
13. WHO Regulation and Prequalification Department Annual Report 2025 · PDF page 19
Narrow public claim
More than 2.8 billion doses of WHO-prequalified vaccines were delivered to 99 countries, primarily through routine immunization programmes targeting young children.
What this card proves
The exact quoted statement occurred in the named official PDF fetched on 2026-08-17, and the complete PDF matched the recorded SHA-256.
What this card does not prove
It does not independently establish the underlying model capability, safety, comparison, or real-world truth. This is a retrospective single-maintainer source-publication audit.
- Primary source
- WHO Regulation and Prequalification Department Annual Report 2025
- Section locator
PDF page 19- Captured
- 2026-08-17
- Source SHA-256
489f48ce81a7d8294ced574a7dad00a821de912b07cdb81437386854708895c3- Reproduction
- Maintainer run only; no independent operator rerun is registered.
Repeat this exact check locally
Download the PDF to a local file, then run the committed verifier. A changed PDF is reported as drift rather than silently accepted.
python scripts/verify_primary_public_claim_group.py artifacts/cb7k_dom021_t02_primary_claims.json --source-file <local-raw-pdf>Exact source quote
More than 2.8 billion doses of WHO-prequalified vaccines were delivered to 99 countries, primarily through routine immunization programmes targeting young children.
14. WHO Regulation and Prequalification Department Annual Report 2025 · PDF page 19
Narrow public claim
Since 2000, immunization programmes using WHO-prequalified vaccines have contributed to an estimated 20.6 million deaths averted.
What this card proves
The exact quoted statement occurred in the named official PDF fetched on 2026-08-17, and the complete PDF matched the recorded SHA-256.
What this card does not prove
It does not independently establish the underlying model capability, safety, comparison, or real-world truth. This is a retrospective single-maintainer source-publication audit.
- Primary source
- WHO Regulation and Prequalification Department Annual Report 2025
- Section locator
PDF page 19- Captured
- 2026-08-17
- Source SHA-256
489f48ce81a7d8294ced574a7dad00a821de912b07cdb81437386854708895c3- Reproduction
- Maintainer run only; no independent operator rerun is registered.
Repeat this exact check locally
Download the PDF to a local file, then run the committed verifier. A changed PDF is reported as drift rather than silently accepted.
python scripts/verify_primary_public_claim_group.py artifacts/cb7k_dom021_t02_primary_claims.json --source-file <local-raw-pdf>Exact source quote
Since 2000, immunization programmes using WHO-prequalified vaccines have contributed to an estimated 20.6 million deaths averted.
15. WHO Regulation and Prequalification Department Annual Report 2025 · PDF page 19
Narrow public claim
Maternal respiratory syncytial virus vaccination is already reducing severe disease and hospitalizations among newborns and young infants, while deployment of more than 1.5 billion prequalified polio vaccine doses has supported continued reductions in global polio cases.
What this card proves
The exact quoted statement occurred in the named official PDF fetched on 2026-08-17, and the complete PDF matched the recorded SHA-256.
What this card does not prove
It does not independently establish the underlying model capability, safety, comparison, or real-world truth. This is a retrospective single-maintainer source-publication audit.
- Primary source
- WHO Regulation and Prequalification Department Annual Report 2025
- Section locator
PDF page 19- Captured
- 2026-08-17
- Source SHA-256
489f48ce81a7d8294ced574a7dad00a821de912b07cdb81437386854708895c3- Reproduction
- Maintainer run only; no independent operator rerun is registered.
Repeat this exact check locally
Download the PDF to a local file, then run the committed verifier. A changed PDF is reported as drift rather than silently accepted.
python scripts/verify_primary_public_claim_group.py artifacts/cb7k_dom021_t02_primary_claims.json --source-file <local-raw-pdf>Exact source quote
Maternal respiratory syncytial virus vaccination is already reducing severe disease and hospitalizations among newborns and young infants, while deployment of more than 1.5 billion prequalified polio vaccine doses has supported continued reductions in global polio cases.
16. WHO Regulation and Prequalification Department Annual Report 2025 · PDF page 19
Narrow public claim
In addition, over 100 million children were immunized against measles using WHO-prequalified vaccines, preventing illness and saving lives.
What this card proves
The exact quoted statement occurred in the named official PDF fetched on 2026-08-17, and the complete PDF matched the recorded SHA-256.
What this card does not prove
It does not independently establish the underlying model capability, safety, comparison, or real-world truth. This is a retrospective single-maintainer source-publication audit.
- Primary source
- WHO Regulation and Prequalification Department Annual Report 2025
- Section locator
PDF page 19- Captured
- 2026-08-17
- Source SHA-256
489f48ce81a7d8294ced574a7dad00a821de912b07cdb81437386854708895c3- Reproduction
- Maintainer run only; no independent operator rerun is registered.
Repeat this exact check locally
Download the PDF to a local file, then run the committed verifier. A changed PDF is reported as drift rather than silently accepted.
python scripts/verify_primary_public_claim_group.py artifacts/cb7k_dom021_t02_primary_claims.json --source-file <local-raw-pdf>Exact source quote
In addition, over 100 million children were immunized against measles using WHO-prequalified vaccines, preventing illness and saving lives.
17. WHO Regulation and Prequalification Department Annual Report 2025 · PDF page 20
Narrow public claim
Ethiopia now joins Egypt, Ghana, Nigeria, Rwanda, Senegal, South Africa, the United Republic of Tanzania and Zimbabwe among African countries that have reached Maturity Level 3, supporting greater regulatory convergence and improved access to quality-assured health products across the region.
What this card proves
The exact quoted statement occurred in the named official PDF fetched on 2026-08-17, and the complete PDF matched the recorded SHA-256.
What this card does not prove
It does not independently establish the underlying model capability, safety, comparison, or real-world truth. This is a retrospective single-maintainer source-publication audit.
- Primary source
- WHO Regulation and Prequalification Department Annual Report 2025
- Section locator
PDF page 20- Captured
- 2026-08-17
- Source SHA-256
489f48ce81a7d8294ced574a7dad00a821de912b07cdb81437386854708895c3- Reproduction
- Maintainer run only; no independent operator rerun is registered.
Repeat this exact check locally
Download the PDF to a local file, then run the committed verifier. A changed PDF is reported as drift rather than silently accepted.
python scripts/verify_primary_public_claim_group.py artifacts/cb7k_dom021_t02_primary_claims.json --source-file <local-raw-pdf>Exact source quote
Ethiopia now joins Egypt, Ghana, Nigeria, Rwanda, Senegal, South Africa, the United Republic of Tanzania and Zimbabwe among African countries that have reached Maturity Level 3, supporting greater regulatory convergence and improved access to quality-assured health products across the region.
18. WHO Regulation and Prequalification Department Annual Report 2025 · PDF page 20
Narrow public claim
Lenacapavir was also approved in an accelerated manner in Botswana, Malawi, Rwanda and Tanzania in 2025.
What this card proves
The exact quoted statement occurred in the named official PDF fetched on 2026-08-17, and the complete PDF matched the recorded SHA-256.
What this card does not prove
It does not independently establish the underlying model capability, safety, comparison, or real-world truth. This is a retrospective single-maintainer source-publication audit.
- Primary source
- WHO Regulation and Prequalification Department Annual Report 2025
- Section locator
PDF page 20- Captured
- 2026-08-17
- Source SHA-256
489f48ce81a7d8294ced574a7dad00a821de912b07cdb81437386854708895c3- Reproduction
- Maintainer run only; no independent operator rerun is registered.
Repeat this exact check locally
Download the PDF to a local file, then run the committed verifier. A changed PDF is reported as drift rather than silently accepted.
python scripts/verify_primary_public_claim_group.py artifacts/cb7k_dom021_t02_primary_claims.json --source-file <local-raw-pdf>Exact source quote
Lenacapavir was also approved in an accelerated manner in Botswana, Malawi, Rwanda and Tanzania in 2025.
19. WHO Regulation and Prequalification Department Annual Report 2025 · PDF page 21
Narrow public claim
Impact Australia, Canada, Indonesia, Japan and the United Kingdom achieve status as WHO Listed Authorities In 2025, Australia, Canada, Indonesia, Japan and the United Kingdom have been recognized by WHO as listed authorities for medical products regulation, marking a significant milestone in global regulatory excellence.
What this card proves
The exact quoted statement occurred in the named official PDF fetched on 2026-08-17, and the complete PDF matched the recorded SHA-256.
What this card does not prove
It does not independently establish the underlying model capability, safety, comparison, or real-world truth. This is a retrospective single-maintainer source-publication audit.
- Primary source
- WHO Regulation and Prequalification Department Annual Report 2025
- Section locator
PDF page 21- Captured
- 2026-08-17
- Source SHA-256
489f48ce81a7d8294ced574a7dad00a821de912b07cdb81437386854708895c3- Reproduction
- Maintainer run only; no independent operator rerun is registered.
Repeat this exact check locally
Download the PDF to a local file, then run the committed verifier. A changed PDF is reported as drift rather than silently accepted.
python scripts/verify_primary_public_claim_group.py artifacts/cb7k_dom021_t02_primary_claims.json --source-file <local-raw-pdf>Exact source quote
Impact Australia, Canada, Indonesia, Japan and the United Kingdom achieve status as WHO Listed Authorities In 2025, Australia, Canada, Indonesia, Japan and the United Kingdom have been recognized by WHO as listed authorities for medical products regulation, marking a significant milestone in global regulatory excellence.
20. WHO Regulation and Prequalification Department Annual Report 2025 · PDF page 21
Narrow public claim
The WHO Listed Authorities framework supports regulatory reliance, reduces duplication and accelerates access to safe, quality-assured medicines and vaccines, strengthening collaboration and supply chain resilience worldwide.
What this card proves
The exact quoted statement occurred in the named official PDF fetched on 2026-08-17, and the complete PDF matched the recorded SHA-256.
What this card does not prove
It does not independently establish the underlying model capability, safety, comparison, or real-world truth. This is a retrospective single-maintainer source-publication audit.
- Primary source
- WHO Regulation and Prequalification Department Annual Report 2025
- Section locator
PDF page 21- Captured
- 2026-08-17
- Source SHA-256
489f48ce81a7d8294ced574a7dad00a821de912b07cdb81437386854708895c3- Reproduction
- Maintainer run only; no independent operator rerun is registered.
Repeat this exact check locally
Download the PDF to a local file, then run the committed verifier. A changed PDF is reported as drift rather than silently accepted.
python scripts/verify_primary_public_claim_group.py artifacts/cb7k_dom021_t02_primary_claims.json --source-file <local-raw-pdf>Exact source quote
The WHO Listed Authorities framework supports regulatory reliance, reduces duplication and accelerates access to safe, quality-assured medicines and vaccines, strengthening collaboration and supply chain resilience worldwide.
21. WHO Regulation and Prequalification Department Annual Report 2025 · PDF page 21
Narrow public claim
By expanding and diversifying the network of listed authorities, WHO and its Member States are moving closer to a more inclusive, efficient and globally connected regulatory ecosystem – one that supports equitable and timely access to safe, effective and quality-assured health products for all, everywhere.
What this card proves
The exact quoted statement occurred in the named official PDF fetched on 2026-08-17, and the complete PDF matched the recorded SHA-256.
What this card does not prove
It does not independently establish the underlying model capability, safety, comparison, or real-world truth. This is a retrospective single-maintainer source-publication audit.
- Primary source
- WHO Regulation and Prequalification Department Annual Report 2025
- Section locator
PDF page 21- Captured
- 2026-08-17
- Source SHA-256
489f48ce81a7d8294ced574a7dad00a821de912b07cdb81437386854708895c3- Reproduction
- Maintainer run only; no independent operator rerun is registered.
Repeat this exact check locally
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By expanding and diversifying the network of listed authorities, WHO and its Member States are moving closer to a more inclusive, efficient and globally connected regulatory ecosystem – one that supports equitable and timely access to safe, effective and quality-assured health products for all, everywhere.
22. WHO Regulation and Prequalification Department Annual Report 2025 · PDF page 21
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The African Region received the largest share of activities, reflecting priority capacity needs, and 56% of participants worldwide were women, supporting a more inclusive and sustainable regulatory workforce.
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- WHO Regulation and Prequalification Department Annual Report 2025
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- 2026-08-17
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The African Region received the largest share of activities, reflecting priority capacity needs, and 56% of participants worldwide were women, supporting a more inclusive and sustainable regulatory workforce.
23. WHO Regulation and Prequalification Department Annual Report 2025 · PDF page 21
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New training offers addressed urgent risks such as crisis communication for substandard and falsified medical products and detection of toxic substances like diethylene glycol and ethylene glycol in high-risk excipients.
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- WHO Regulation and Prequalification Department Annual Report 2025
- Section locator
PDF page 21- Captured
- 2026-08-17
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New training offers addressed urgent risks such as crisis communication for substandard and falsified medical products and detection of toxic substances like diethylene glycol and ethylene glycol in high-risk excipients.
24. WHO Regulation and Prequalification Department Annual Report 2025 · PDF page 22
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WHO supports countries in strengthening human and institutional capacities to build climate-resilient and environmentally sustainable health systems, and the Department of Regulation and Prequalification contributes to this agenda in multiple ways.
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- WHO Regulation and Prequalification Department Annual Report 2025
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- 2026-08-17
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WHO supports countries in strengthening human and institutional capacities to build climate-resilient and environmentally sustainable health systems, and the Department of Regulation and Prequalification contributes to this agenda in multiple ways.
25. WHO Regulation and Prequalification Department Annual Report 2025 · PDF page 26
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In June 2025, a new WHO collaborative registration pathway for vector control products was launched, extending reliance-based approaches to products critical for disease prevention and control.
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- WHO Regulation and Prequalification Department Annual Report 2025
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- 2026-08-17
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In June 2025, a new WHO collaborative registration pathway for vector control products was launched, extending reliance-based approaches to products critical for disease prevention and control.
26. WHO Regulation and Prequalification Department Annual Report 2025 · PDF page 26
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Following public consultation, new regulatory considerations for medical oxygen were adopted by the WHO Expert Committee on Specifications for Pharmaceutical Preparations in October 2025, reflecting regulation of a widening range of medical products.
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- 2026-08-17
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Following public consultation, new regulatory considerations for medical oxygen were adopted by the WHO Expert Committee on Specifications for Pharmaceutical Preparations in October 2025, reflecting regulation of a widening range of medical products.
27. WHO Regulation and Prequalification Department Annual Report 2025 · PDF page 31
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Audits of established and candidate laboratories were conducted in the People's Republic of China, India and South Africa, alongside increased reliance on mutual joint audit outcomes from trusted authorities including Paul Ehrlich Institute, Sciensano in Belgium, the Bulgarian Drug Agency, the National Institute for Biological Standards and Control in the United Kingdom and the Instituto Superiore di Sanita, Italy.
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The exact quoted statement occurred in the named official PDF fetched on 2026-08-17, and the complete PDF matched the recorded SHA-256.
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- WHO Regulation and Prequalification Department Annual Report 2025
- Section locator
PDF page 31- Captured
- 2026-08-17
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Audits of established and candidate laboratories were conducted in the People's Republic of China, India and South Africa, alongside increased reliance on mutual joint audit outcomes from trusted authorities including Paul Ehrlich Institute, Sciensano in Belgium, the Bulgarian Drug Agency, the National Institute for Biological Standards and Control in the United Kingdom and the Instituto Superiore di Sanita, Italy.
28. WHO Regulation and Prequalification Department Annual Report 2025 · PDF page 33
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Support to global and regional convergence and harmonization WHO continues to offer its convening power bringing regulators together through international and regional meetings, technical committees and global forums focused on convergence and harmonization, providing important opportunities for regulators to exchange experience, align technical approaches and coordinate responses to emerging regulatory challenges.
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- WHO Regulation and Prequalification Department Annual Report 2025
- Section locator
PDF page 33- Captured
- 2026-08-17
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Support to global and regional convergence and harmonization WHO continues to offer its convening power bringing regulators together through international and regional meetings, technical committees and global forums focused on convergence and harmonization, providing important opportunities for regulators to exchange experience, align technical approaches and coordinate responses to emerging regulatory challenges.
29. WHO Regulation and Prequalification Department Annual Report 2025 · PDF page 35
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At the regional level, these activities are coordinated through Regional Economic Communities fostering regulatory convergence, harmonization, work-sharing, and collaboration among Member States.
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- WHO Regulation and Prequalification Department Annual Report 2025
- Section locator
PDF page 35- Captured
- 2026-08-17
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At the regional level, these activities are coordinated through Regional Economic Communities fostering regulatory convergence, harmonization, work-sharing, and collaboration among Member States.
30. WHO Regulation and Prequalification Department Annual Report 2025 · PDF page 39
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As next steps, focus will be on the integration of data analytics from WHO Academy on RPQ e-learnings for more comprehensive reporting, as well as the systematic implementation of mechanisms to evaluate and report on training effectiveness.
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The exact quoted statement occurred in the named official PDF fetched on 2026-08-17, and the complete PDF matched the recorded SHA-256.
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- WHO Regulation and Prequalification Department Annual Report 2025
- Section locator
PDF page 39- Captured
- 2026-08-17
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As next steps, focus will be on the integration of data analytics from WHO Academy on RPQ e-learnings for more comprehensive reporting, as well as the systematic implementation of mechanisms to evaluate and report on training effectiveness.
31. WHO Regulation and Prequalification Department Annual Report 2025 · PDF page 39
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Improvements to training processes, use of shared templates, tools, and standard operating procedures enabling greater efficiency amid tightening constraints on time, staffing and funding.
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The exact quoted statement occurred in the named official PDF fetched on 2026-08-17, and the complete PDF matched the recorded SHA-256.
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- WHO Regulation and Prequalification Department Annual Report 2025
- Section locator
PDF page 39- Captured
- 2026-08-17
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Improvements to training processes, use of shared templates, tools, and standard operating procedures enabling greater efficiency amid tightening constraints on time, staffing and funding.
32. WHO Regulation and Prequalification Department Annual Report 2025 · PDF page 39
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Going forward, the WHO Academy in Lyon, France through its learning platform will enable the development of even more advanced learning solutions, in collaboration with a broad network of partner institutions.
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The exact quoted statement occurred in the named official PDF fetched on 2026-08-17, and the complete PDF matched the recorded SHA-256.
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- WHO Regulation and Prequalification Department Annual Report 2025
- Section locator
PDF page 39- Captured
- 2026-08-17
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Going forward, the WHO Academy in Lyon, France through its learning platform will enable the development of even more advanced learning solutions, in collaboration with a broad network of partner institutions.
33. WHO Regulation and Prequalification Department Annual Report 2025 · PDF page 41
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WHO will now work with countries to operationalize the strategy, in close collaboration with global and regional networks, drawing on the principles of work-sharing and reliance.
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The exact quoted statement occurred in the named official PDF fetched on 2026-08-17, and the complete PDF matched the recorded SHA-256.
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- WHO Regulation and Prequalification Department Annual Report 2025
- Section locator
PDF page 41- Captured
- 2026-08-17
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WHO will now work with countries to operationalize the strategy, in close collaboration with global and regional networks, drawing on the principles of work-sharing and reliance.
34. WHO Regulation and Prequalification Department Annual Report 2025 · PDF page 41
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Vaccines, thimerosal and autism spectrum disorder The Global Advisory Committee on Vaccine Safety reviewed all evidence from 2010 – 2025 regarding a potential link between vaccines and autism, and concluded that vaccines do not cause autism, reinforcing the conclusion from multiple reviews between 2002 and 2012.
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The exact quoted statement occurred in the named official PDF fetched on 2026-08-17, and the complete PDF matched the recorded SHA-256.
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- WHO Regulation and Prequalification Department Annual Report 2025
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PDF page 41- Captured
- 2026-08-17
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Vaccines, thimerosal and autism spectrum disorder The Global Advisory Committee on Vaccine Safety reviewed all evidence from 2010 – 2025 regarding a potential link between vaccines and autism, and concluded that vaccines do not cause autism, reinforcing the conclusion from multiple reviews between 2002 and 2012.
35. WHO Regulation and Prequalification Department Annual Report 2025 · PDF page 44
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Capacity-building and training for safety monitoring In 2025, more than 1200 participants were trained through workshops and courses now available in the WHO Academy, Lyon, France.
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- WHO Regulation and Prequalification Department Annual Report 2025
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- 2026-08-17
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Capacity-building and training for safety monitoring In 2025, more than 1200 participants were trained through workshops and courses now available in the WHO Academy, Lyon, France.
36. WHO Regulation and Prequalification Department Annual Report 2025 · PDF page 47
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In 2025, nearly 1030 incidents of substandard and falsified medical products were reported to WHO, 83% were reported by national regulatory authorities with 24% of reports made directly via the portal.
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The exact quoted statement occurred in the named official PDF fetched on 2026-08-17, and the complete PDF matched the recorded SHA-256.
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- WHO Regulation and Prequalification Department Annual Report 2025
- Section locator
PDF page 47- Captured
- 2026-08-17
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In 2025, nearly 1030 incidents of substandard and falsified medical products were reported to WHO, 83% were reported by national regulatory authorities with 24% of reports made directly via the portal.
37. WHO Regulation and Prequalification Department Annual Report 2025 · PDF page 48
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The WHO Global Surveillance and Monitoring System for SF medical products includes a case-report database.
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The exact quoted statement occurred in the named official PDF fetched on 2026-08-17, and the complete PDF matched the recorded SHA-256.
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- WHO Regulation and Prequalification Department Annual Report 2025
- Section locator
PDF page 48- Captured
- 2026-08-17
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The WHO Global Surveillance and Monitoring System for SF medical products includes a case-report database.
38. WHO Regulation and Prequalification Department Annual Report 2025 · PDF page 48
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The data cannot and should not be extrapolated to represent any form of prevalence.
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The exact quoted statement occurred in the named official PDF fetched on 2026-08-17, and the complete PDF matched the recorded SHA-256.
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- WHO Regulation and Prequalification Department Annual Report 2025
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PDF page 48- Captured
- 2026-08-17
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The data cannot and should not be extrapolated to represent any form of prevalence.
39. WHO Regulation and Prequalification Department Annual Report 2025 · PDF page 48
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Reporting levels are indicative of the capacity to detect and report incidents .
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The exact quoted statement occurred in the named official PDF fetched on 2026-08-17, and the complete PDF matched the recorded SHA-256.
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It does not independently establish the underlying model capability, safety, comparison, or real-world truth. This is a retrospective single-maintainer source-publication audit.
- Primary source
- WHO Regulation and Prequalification Department Annual Report 2025
- Section locator
PDF page 48- Captured
- 2026-08-17
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Reporting levels are indicative of the capacity to detect and report incidents .
40. WHO Regulation and Prequalification Department Annual Report 2025 · PDF page 49
Narrow public claim
A Training Toolkit on Substandard and Falsified Medical Products was launched in September 2025, with open access for national regulatory authorities, academia and law enforcement institutions, including a competency framework, curriculum guide, trainers’ guide and technical resources; with more than 400 participants attending the launching webinar.
What this card proves
The exact quoted statement occurred in the named official PDF fetched on 2026-08-17, and the complete PDF matched the recorded SHA-256.
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It does not independently establish the underlying model capability, safety, comparison, or real-world truth. This is a retrospective single-maintainer source-publication audit.
- Primary source
- WHO Regulation and Prequalification Department Annual Report 2025
- Section locator
PDF page 49- Captured
- 2026-08-17
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A Training Toolkit on Substandard and Falsified Medical Products was launched in September 2025, with open access for national regulatory authorities, academia and law enforcement institutions, including a competency framework, curriculum guide, trainers’ guide and technical resources; with more than 400 participants attending the launching webinar.
41. WHO Regulation and Prequalification Department Annual Report 2025 · PDF page 51
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Since 2023, the WHO Neglected Tropical Diseases Programme has launched several pilot rounds of Expert Review Panels for neglected tropical diseases, and Gavi, the Vaccine Alliance has launched an Expert Review Panel for Diagnostics for vaccine-preventable diseases, facilitating faster access to innovative products.
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The exact quoted statement occurred in the named official PDF fetched on 2026-08-17, and the complete PDF matched the recorded SHA-256.
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- WHO Regulation and Prequalification Department Annual Report 2025
- Section locator
PDF page 51- Captured
- 2026-08-17
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Since 2023, the WHO Neglected Tropical Diseases Programme has launched several pilot rounds of Expert Review Panels for neglected tropical diseases, and Gavi, the Vaccine Alliance has launched an Expert Review Panel for Diagnostics for vaccine-preventable diseases, facilitating faster access to innovative products.
42. WHO Regulation and Prequalification Department Annual Report 2025 · PDF page 52
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Preparedness and Response Plan covering the period September 2024 – February 2025, an updated Plan was issued in March 2025 presenting a set of actions through to August 2025.
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The exact quoted statement occurred in the named official PDF fetched on 2026-08-17, and the complete PDF matched the recorded SHA-256.
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- Primary source
- WHO Regulation and Prequalification Department Annual Report 2025
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PDF page 52- Captured
- 2026-08-17
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Preparedness and Response Plan covering the period September 2024 – February 2025, an updated Plan was issued in March 2025 presenting a set of actions through to August 2025.
43. WHO Regulation and Prequalification Department Annual Report 2025 · PDF page 52
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On 28 August 2024 WHO published an invitation to manufacturers to submit in vitro diagnostics for mpox detection for review by WHO through the Emergency Use Listing.
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- 2026-08-17
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On 28 August 2024 WHO published an invitation to manufacturers to submit in vitro diagnostics for mpox detection for review by WHO through the Emergency Use Listing.
44. WHO Regulation and Prequalification Department Annual Report 2025 · PDF page 63
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WHO prequalification of polio vaccines is an important component of these efforts.
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- WHO Regulation and Prequalification Department Annual Report 2025
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WHO prequalification of polio vaccines is an important component of these efforts.
45. WHO Regulation and Prequalification Department Annual Report 2025 · PDF page 63
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As of today, about 1.3 billion doses have been administered in 41 countries.
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- WHO Regulation and Prequalification Department Annual Report 2025
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As of today, about 1.3 billion doses have been administered in 41 countries.
46. WHO Regulation and Prequalification Department Annual Report 2025 · PDF page 69
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The expanded abridged pathways which includes a new prequalification pathway for products already approved by a stringent or WHO Listed Authorities for use only outside the region of these authorities and an abridged prequalification procedure for products already marketed by stringent or WHO Listed Authorities, whereby these authorities share unredacted assessment and inspection reports with WHO Prequalification and as needed for further sharing with the national regulatory authority participating in WHO Collaborative Registration Procedures.
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- WHO Regulation and Prequalification Department Annual Report 2025
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PDF page 69- Captured
- 2026-08-17
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The expanded abridged pathways which includes a new prequalification pathway for products already approved by a stringent or WHO Listed Authorities for use only outside the region of these authorities and an abridged prequalification procedure for products already marketed by stringent or WHO Listed Authorities, whereby these authorities share unredacted assessment and inspection reports with WHO Prequalification and as needed for further sharing with the national regulatory authority participating in WHO Collaborative Registration Procedures.
47. WHO Regulation and Prequalification Department Annual Report 2025 · PDF page 69
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Capacity-building and training for quality assurance of medicines An important part of the prequalification of medicines process is to build the capacity of staff from national regulatory authorities, quality control laboratories and manufacturers to ensure that medicines quality is attained and maintained.
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The exact quoted statement occurred in the named official PDF fetched on 2026-08-17, and the complete PDF matched the recorded SHA-256.
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PDF page 69- Captured
- 2026-08-17
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Capacity-building and training for quality assurance of medicines An important part of the prequalification of medicines process is to build the capacity of staff from national regulatory authorities, quality control laboratories and manufacturers to ensure that medicines quality is attained and maintained.
48. WHO Regulation and Prequalification Department Annual Report 2025 · PDF page 69
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In 2025, more than 40 assessors from low-and middle-income countries were trained through participation in the bimonthly prequalification of medicines assessment sessions, offering a unique platform for hands-on mentoring and exchange of experience with highly experienced assessors and experts.
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In 2025, more than 40 assessors from low-and middle-income countries were trained through participation in the bimonthly prequalification of medicines assessment sessions, offering a unique platform for hands-on mentoring and exchange of experience with highly experienced assessors and experts.
49. WHO Regulation and Prequalification Department Annual Report 2025 · PDF page 72
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For lymphatic filariasis, following the WHO Neglected Tropical Diseases Programme recommendation, 2 million rapid diagnostic tests were procured and supplied to 48 countries, contributing to meet the targets set out in the Global Roadmap for Neglected Tropical Diseases 2021–2030.
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For lymphatic filariasis, following the WHO Neglected Tropical Diseases Programme recommendation, 2 million rapid diagnostic tests were procured and supplied to 48 countries, contributing to meet the targets set out in the Global Roadmap for Neglected Tropical Diseases 2021–2030.
50. WHO Regulation and Prequalification Department Annual Report 2025 · PDF page 72
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In addition, an amended and streamlined prequalification procedure for in vitro diagnostics was developed, expected to enable further efficiencies.
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In addition, an amended and streamlined prequalification procedure for in vitro diagnostics was developed, expected to enable further efficiencies.
51. WHO Regulation and Prequalification Department Annual Report 2025 · PDF page 73
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WHO continued direct engagement with manufacturers to support quality improvement and regulatory preparedness across the in vitro diagnostics pipeline, including three workshops for Asian in vitro diagnostic manufacturers throughout the year, in Jakarta, Indonesia, Seoul, Republic of Korea and in Guangzhou, the People’s Republic of China, engaging over 300 participants to strengthen understanding of prequalification requirements, submission of higher-quality dossiers, industry capacity and regulatory alignment.
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The exact quoted statement occurred in the named official PDF fetched on 2026-08-17, and the complete PDF matched the recorded SHA-256.
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PDF page 73- Captured
- 2026-08-17
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WHO continued direct engagement with manufacturers to support quality improvement and regulatory preparedness across the in vitro diagnostics pipeline, including three workshops for Asian in vitro diagnostic manufacturers throughout the year, in Jakarta, Indonesia, Seoul, Republic of Korea and in Guangzhou, the People’s Republic of China, engaging over 300 participants to strengthen understanding of prequalification requirements, submission of higher-quality dossiers, industry capacity and regulatory alignment.
52. WHO Regulation and Prequalification Department Annual Report 2025 · PDF page 75
Narrow public claim
WHO also published two major guidance documents for insecticide treated nets, long-term community studies and "Considerations for post-market surveillance of WHO prequalified insecticide treated nets.” In complementarity, procedures for confirmation of compliance of vector control active ingredient sources was published to enable the listing of source materials found to meet WHO specifications based on scientific assessments conducted through the Joint Meeting on Pesticide Specifications.
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The exact quoted statement occurred in the named official PDF fetched on 2026-08-17, and the complete PDF matched the recorded SHA-256.
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- WHO Regulation and Prequalification Department Annual Report 2025
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PDF page 75- Captured
- 2026-08-17
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WHO also published two major guidance documents for insecticide treated nets, long-term community studies and "Considerations for post-market surveillance of WHO prequalified insecticide treated nets.” In complementarity, procedures for confirmation of compliance of vector control active ingredient sources was published to enable the listing of source materials found to meet WHO specifications based on scientific assessments conducted through the Joint Meeting on Pesticide Specifications.
53. WHO Regulation and Prequalification Department Annual Report 2025 · PDF page 75
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From its work through the Joint Meeting, 11 updated WHO and specifications were issued jointly in 2025 by WHO and the UN Food and Agricultural Organization.
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The exact quoted statement occurred in the named official PDF fetched on 2026-08-17, and the complete PDF matched the recorded SHA-256.
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- WHO Regulation and Prequalification Department Annual Report 2025
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PDF page 75- Captured
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From its work through the Joint Meeting, 11 updated WHO and specifications were issued jointly in 2025 by WHO and the UN Food and Agricultural Organization.
54. WHO Regulation and Prequalification Department Annual Report 2025 · PDF page 80
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Inspections were conducted across all WHO regions, however with a strong focus on the People's Republic of China and India being the major suppliers of medical products.
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The exact quoted statement occurred in the named official PDF fetched on 2026-08-17, and the complete PDF matched the recorded SHA-256.
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Inspections were conducted across all WHO regions, however with a strong focus on the People's Republic of China and India being the major suppliers of medical products.
55. WHO Regulation and Prequalification Department Annual Report 2025 · PDF page 85
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Thus, parallel with the increasing scope and complexity of the WHO Prequalification Programme, a growing mismatch has emerged between service delivery costs and fee income.
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Thus, parallel with the increasing scope and complexity of the WHO Prequalification Programme, a growing mismatch has emerged between service delivery costs and fee income.
56. WHO Regulation and Prequalification Department Annual Report 2025 · PDF page 86
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Women accounted for 56% of trainees, and a high proportion of participants were early- and mid-career professionals, supporting long-term sustainability of regulatory expertise.
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The exact quoted statement occurred in the named official PDF fetched on 2026-08-17, and the complete PDF matched the recorded SHA-256.
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Women accounted for 56% of trainees, and a high proportion of participants were early- and mid-career professionals, supporting long-term sustainability of regulatory expertise.
57. WHO Regulation and Prequalification Department Annual Report 2025 · PDF page 89
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Digitalization and artificial intelligence in the health sector There is a growing consensus that the strategic and innovative use of digital and cutting-edge information and communications technologies will be an essential enabling factor towards ensuring the achievements of the Sustainable Development Goals.
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PDF page 89- Captured
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Digitalization and artificial intelligence in the health sector There is a growing consensus that the strategic and innovative use of digital and cutting-edge information and communications technologies will be an essential enabling factor towards ensuring the achievements of the Sustainable Development Goals.
58. WHO Regulation and Prequalification Department Annual Report 2025 · PDF page 89
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WHO is actively promoting digital health initiatives to enhance global health outcomes through the integration of digital technologies into health systems, including for its own operations.
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The exact quoted statement occurred in the named official PDF fetched on 2026-08-17, and the complete PDF matched the recorded SHA-256.
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PDF page 89- Captured
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WHO is actively promoting digital health initiatives to enhance global health outcomes through the integration of digital technologies into health systems, including for its own operations.
59. WHO Regulation and Prequalification Department Annual Report 2025 · PDF page 89
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WHO also supports a science-based adoption of Artificial Intelligence with the goal to ensure that its advancements contribute to global health in a way that is safe, ethical, and equitable, with appropriate governance and regulation.
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The exact quoted statement occurred in the named official PDF fetched on 2026-08-17, and the complete PDF matched the recorded SHA-256.
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PDF page 89- Captured
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WHO also supports a science-based adoption of Artificial Intelligence with the goal to ensure that its advancements contribute to global health in a way that is safe, ethical, and equitable, with appropriate governance and regulation.
60. WHO Regulation and Prequalification Department Annual Report 2025 · PDF page 89
Narrow public claim
WHO is therefore actively engaged in developing guidance on governance, ethical standards and regulations to address emerging opportunities and challenges, mitigate risks, safeguard public health.
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The exact quoted statement occurred in the named official PDF fetched on 2026-08-17, and the complete PDF matched the recorded SHA-256.
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PDF page 89- Captured
- 2026-08-17
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WHO is therefore actively engaged in developing guidance on governance, ethical standards and regulations to address emerging opportunities and challenges, mitigate risks, safeguard public health.
61. WHO Regulation and Prequalification Department Annual Report 2025 · PDF page 89
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Use of both the ePQS portal and eCTD format remained voluntary in 2025 with transition to mandatory use planned for early 2026.
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The exact quoted statement occurred in the named official PDF fetched on 2026-08-17, and the complete PDF matched the recorded SHA-256.
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- WHO Regulation and Prequalification Department Annual Report 2025
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PDF page 89- Captured
- 2026-08-17
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Use of both the ePQS portal and eCTD format remained voluntary in 2025 with transition to mandatory use planned for early 2026.
62. WHO Regulation and Prequalification Department Annual Report 2025 · PDF page 90
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This work is in its early stages, and will include a needs assessment, collaboration with the WHO Information Technology Department.
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The exact quoted statement occurred in the named official PDF fetched on 2026-08-17, and the complete PDF matched the recorded SHA-256.
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- WHO Regulation and Prequalification Department Annual Report 2025
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PDF page 90- Captured
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This work is in its early stages, and will include a needs assessment, collaboration with the WHO Information Technology Department.
63. WHO Regulation and Prequalification Department Annual Report 2025 · PDF page 91
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In addition, WHO Member States approved the historic Pandemic Agreement in May 2025, marking a milestone in strengthening international collaboration for pandemic preparedness and response.
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The exact quoted statement occurred in the named official PDF fetched on 2026-08-17, and the complete PDF matched the recorded SHA-256.
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PDF page 91- Captured
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In addition, WHO Member States approved the historic Pandemic Agreement in May 2025, marking a milestone in strengthening international collaboration for pandemic preparedness and response.
64. WHO Regulation and Prequalification Department Annual Report 2025 · PDF page 91
Narrow public claim
Quality and safety have remained at the core of WHO’s mission since its Constitution entered into force in 1948.
What this card proves
The exact quoted statement occurred in the named official PDF fetched on 2026-08-17, and the complete PDF matched the recorded SHA-256.
What this card does not prove
It does not independently establish the underlying model capability, safety, comparison, or real-world truth. This is a retrospective single-maintainer source-publication audit.
- Primary source
- WHO Regulation and Prequalification Department Annual Report 2025
- Section locator
PDF page 91- Captured
- 2026-08-17
- Source SHA-256
489f48ce81a7d8294ced574a7dad00a821de912b07cdb81437386854708895c3- Reproduction
- Maintainer run only; no independent operator rerun is registered.
Repeat this exact check locally
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python scripts/verify_primary_public_claim_group.py artifacts/cb7k_dom021_t07_primary_claims.json --source-file <local-raw-pdf>Exact source quote
Quality and safety have remained at the core of WHO’s mission since its Constitution entered into force in 1948.
65. WHO Regulation and Prequalification Department Annual Report 2025 · PDF page 91
Narrow public claim
WHO’s work to ensure quality and safety has continued to evolve in line with emerging therapeutic needs, changing health conditions, and in response to increasing expectations from external partners.
What this card proves
The exact quoted statement occurred in the named official PDF fetched on 2026-08-17, and the complete PDF matched the recorded SHA-256.
What this card does not prove
It does not independently establish the underlying model capability, safety, comparison, or real-world truth. This is a retrospective single-maintainer source-publication audit.
- Primary source
- WHO Regulation and Prequalification Department Annual Report 2025
- Section locator
PDF page 91- Captured
- 2026-08-17
- Source SHA-256
489f48ce81a7d8294ced574a7dad00a821de912b07cdb81437386854708895c3- Reproduction
- Maintainer run only; no independent operator rerun is registered.
Repeat this exact check locally
Download the PDF to a local file, then run the committed verifier. A changed PDF is reported as drift rather than silently accepted.
python scripts/verify_primary_public_claim_group.py artifacts/cb7k_dom021_t07_primary_claims.json --source-file <local-raw-pdf>Exact source quote
WHO’s work to ensure quality and safety has continued to evolve in line with emerging therapeutic needs, changing health conditions, and in response to increasing expectations from external partners.
66. WHO Regulation and Prequalification Department Annual Report 2025 · PDF page 91
Narrow public claim
The Department of Regulation and Prequalification is adapting swiftly to this new reality by aligning with the updated organizational structure, focusing on critical functions, transferring selected responsibilities to other departments and discontinuing others, and streamlining and re-engineering core procedures to improve efficiency and resource mobilization.
What this card proves
The exact quoted statement occurred in the named official PDF fetched on 2026-08-17, and the complete PDF matched the recorded SHA-256.
What this card does not prove
It does not independently establish the underlying model capability, safety, comparison, or real-world truth. This is a retrospective single-maintainer source-publication audit.
- Primary source
- WHO Regulation and Prequalification Department Annual Report 2025
- Section locator
PDF page 91- Captured
- 2026-08-17
- Source SHA-256
489f48ce81a7d8294ced574a7dad00a821de912b07cdb81437386854708895c3- Reproduction
- Maintainer run only; no independent operator rerun is registered.
Repeat this exact check locally
Download the PDF to a local file, then run the committed verifier. A changed PDF is reported as drift rather than silently accepted.
python scripts/verify_primary_public_claim_group.py artifacts/cb7k_dom021_t07_primary_claims.json --source-file <local-raw-pdf>Exact source quote
The Department of Regulation and Prequalification is adapting swiftly to this new reality by aligning with the updated organizational structure, focusing on critical functions, transferring selected responsibilities to other departments and discontinuing others, and streamlining and re-engineering core procedures to improve efficiency and resource mobilization.
67. WHO Regulation and Prequalification Department Annual Report 2025 · PDF page 91
Narrow public claim
In particular, the Department of Regulation and Prequalification will leverage the use of external institutional and human resource capacity, including broader engagement with existing and new WHO Collaborating Centers and non-state actors in official relations; further drawing on the use of the scientific and technical expertise within its networks, advisory groups and task forces; and expand opportunities for secondments, rotational fellowships and other human resource arrangements with Member States.
What this card proves
The exact quoted statement occurred in the named official PDF fetched on 2026-08-17, and the complete PDF matched the recorded SHA-256.
What this card does not prove
It does not independently establish the underlying model capability, safety, comparison, or real-world truth. This is a retrospective single-maintainer source-publication audit.
- Primary source
- WHO Regulation and Prequalification Department Annual Report 2025
- Section locator
PDF page 91- Captured
- 2026-08-17
- Source SHA-256
489f48ce81a7d8294ced574a7dad00a821de912b07cdb81437386854708895c3- Reproduction
- Maintainer run only; no independent operator rerun is registered.
Repeat this exact check locally
Download the PDF to a local file, then run the committed verifier. A changed PDF is reported as drift rather than silently accepted.
python scripts/verify_primary_public_claim_group.py artifacts/cb7k_dom021_t07_primary_claims.json --source-file <local-raw-pdf>Exact source quote
In particular, the Department of Regulation and Prequalification will leverage the use of external institutional and human resource capacity, including broader engagement with existing and new WHO Collaborating Centers and non-state actors in official relations; further drawing on the use of the scientific and technical expertise within its networks, advisory groups and task forces; and expand opportunities for secondments, rotational fellowships and other human resource arrangements with Member States.
68. WHO Regulation and Prequalification Department Annual Report 2025 · PDF page 91
Narrow public claim
While the transition from reliance on prequalification toward fully functional national and regional regulatory systems is expected to be time limited, WHO will continue to require sustained investment and collaboration from key global health partners.
What this card proves
The exact quoted statement occurred in the named official PDF fetched on 2026-08-17, and the complete PDF matched the recorded SHA-256.
What this card does not prove
It does not independently establish the underlying model capability, safety, comparison, or real-world truth. This is a retrospective single-maintainer source-publication audit.
- Primary source
- WHO Regulation and Prequalification Department Annual Report 2025
- Section locator
PDF page 91- Captured
- 2026-08-17
- Source SHA-256
489f48ce81a7d8294ced574a7dad00a821de912b07cdb81437386854708895c3- Reproduction
- Maintainer run only; no independent operator rerun is registered.
Repeat this exact check locally
Download the PDF to a local file, then run the committed verifier. A changed PDF is reported as drift rather than silently accepted.
python scripts/verify_primary_public_claim_group.py artifacts/cb7k_dom021_t07_primary_claims.json --source-file <local-raw-pdf>Exact source quote
While the transition from reliance on prequalification toward fully functional national and regional regulatory systems is expected to be time limited, WHO will continue to require sustained investment and collaboration from key global health partners.
69. WHO Regulation and Prequalification Department Annual Report 2025 · PDF page 91
Narrow public claim
The challenges of 2025 have driven changes that will shape WHO’s work for years to come.
What this card proves
The exact quoted statement occurred in the named official PDF fetched on 2026-08-17, and the complete PDF matched the recorded SHA-256.
What this card does not prove
It does not independently establish the underlying model capability, safety, comparison, or real-world truth. This is a retrospective single-maintainer source-publication audit.
- Primary source
- WHO Regulation and Prequalification Department Annual Report 2025
- Section locator
PDF page 91- Captured
- 2026-08-17
- Source SHA-256
489f48ce81a7d8294ced574a7dad00a821de912b07cdb81437386854708895c3- Reproduction
- Maintainer run only; no independent operator rerun is registered.
Repeat this exact check locally
Download the PDF to a local file, then run the committed verifier. A changed PDF is reported as drift rather than silently accepted.
python scripts/verify_primary_public_claim_group.py artifacts/cb7k_dom021_t07_primary_claims.json --source-file <local-raw-pdf>Exact source quote
The challenges of 2025 have driven changes that will shape WHO’s work for years to come.
70. WHO Regulation and Prequalification Department Annual Report 2025 · PDF page 91
Narrow public claim
The department is making the necessary adjustments to respond to a rapidly evolving global public health agenda and enters 2026 with confidence in a more resilient and productive way forward, with focus on better alignment between the three levels of the Organization.
What this card proves
The exact quoted statement occurred in the named official PDF fetched on 2026-08-17, and the complete PDF matched the recorded SHA-256.
What this card does not prove
It does not independently establish the underlying model capability, safety, comparison, or real-world truth. This is a retrospective single-maintainer source-publication audit.
- Primary source
- WHO Regulation and Prequalification Department Annual Report 2025
- Section locator
PDF page 91- Captured
- 2026-08-17
- Source SHA-256
489f48ce81a7d8294ced574a7dad00a821de912b07cdb81437386854708895c3- Reproduction
- Maintainer run only; no independent operator rerun is registered.
Repeat this exact check locally
Download the PDF to a local file, then run the committed verifier. A changed PDF is reported as drift rather than silently accepted.
python scripts/verify_primary_public_claim_group.py artifacts/cb7k_dom021_t07_primary_claims.json --source-file <local-raw-pdf>Exact source quote
The department is making the necessary adjustments to respond to a rapidly evolving global public health agenda and enters 2026 with confidence in a more resilient and productive way forward, with focus on better alignment between the three levels of the Organization.