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Guidance - Nitrosamine contamination policy for Active Pharmaceutical Ingredients PDF

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Guidance on amendments to an active pharmaceutical ingredient master file (APIMF) submitted in support of a prequalified finished pharmaceutical product (FPP) or prequalified API PDF

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Guidance on bioequivalence studies for reproductive health medicines PDF

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Guidance on plain language descriptions of visual appearance for oral dosage forms in WHOPARs PDF

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Guidance on the Submission of Applications for Prequalification of Zinc Tablets and Zinc Oral Liquid (Solution) PDF

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Guidelines for good clinical practice (GCP) for trials on pharmaceutical products - TRS 850 PDF

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Guidelines on human-Insulin Master File (h-IMF) Procedure PDF

Recently Updated Documents

PQS Application Review Template for E008 AD syringe V1.0 21JUL2025

PQS Application Review Template for E013 RUP syringe V1.0 21JUL2025

Notes on the design of bioequivalence study: cabotegravir + rilpivirine

Notes on the design of bioequivalence study: lamivudine / dolutegravir

ePQS - External Guidance - FPP Post-prequalifiation Change Application

WHO Technical Report Series Location

WHO Technical Report Series documents relating to development, production, distribution, inspection and quality control of medicines can be found in the guidelines section of the WHO web pages dealing with quality assurance of medicines. The guidelines most relevant to WHO medicines prequalification are listed and accessible on the WHO Technical Report Series page.