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WHO / INTERNATIONAL PROCUREMENT

WHO Prequalification

CURRENT · WORLD HEALTH ORGANIZATION

WHO Prequalification of Pharmaceutical Products

TRS 1067 Annex 4, published 9 June 2026, describes assessment of eligible pharmaceutical products against WHO requirements.

Assessment may cover dossiers, API information, manufacturing-site and relevant clinical/CRO inspections, quality-control testing and WHO GMP. Listing is not national market authorization or WHO endorsement.

  1. Product eligibility
  2. Applicable assessment pathway
  3. Dossier / API evidence
  4. GMP and relevant inspections
  5. WHO assessment
View intelligence brief & official sources
Generic medicines readinessReview WHO prequalification relevanceWHO prequalified products & resourcesWHO ePQS Portal

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National market authorization remains separate from WHO prequalification.

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Official facts are attributed to the issuing organization. Pharma Gate interpretation and recommended actions are separate editorial layers, not legal requirements or regulatory approval. Sources are prioritized: national regulators, WHO and recognized intergovernmental bodies, official procurement organizations, then other official governmental or institutional sources.

Publication records retain source title, version, issue date, verification date, country, sector and status. Draft / Public Consultation is distinct from Current. Superseded and Archived records do not represent current requirements. A verification date records the review performed; it is not an assurance of continuous monitoring. Always check the latest official source before acting.