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Guidance on variations to a prequalified vaccine PDF

Guideline/guidance

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

Guideline/guidance

Recently Updated Documents

WHO guideline on Biopharmaceutics Classification System-based biowaiver (2024) - TRS1052, Annex 7

Glucose meters and Test Strips

b) Application Form for PQT Quality workshop 27-30 October 2025

d) Application Form for Biotherapeutics workshop 31 October 2025

a) Agenda_Medicines_QA_Workshop_27-30Oct2025

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.