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Handbook for good clinical research practice: guidance for implementation PDF

Guideline/guidance

IVD

HIV market report: the state of HIV treatment, testing and preventing in low- and middle-income countries (CHAI, September 2020) PDF

Report

HIV mid-year market memo, 2018 20 June 2018 (Clinton Health Access Initiative) PDF

Information note

Recently Updated Documents

Notes on the design of bioequivalence study: pyrimethamine

External Guidance - FPP Assessment Application Wizard Guidance

Quality & BE Assessment Training for AMA affiliated assessors Agenda

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

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

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.