M Application for active pharmaceutical ingredient (API) prequalification based upon previous stringent regulatory authority (SRA) assessment ‒ history of changes (1 May 2013) DOCX Application form
M Application for active pharmaceutical ingredient master file (APIMF) procedure DOCX Application form
M Application for an active pharmaceutical ingredient master file (APIMF) amendment DOCX Application form
M Application for prequalification of an active pharmaceutical ingredient (API-abridged) DOCX Application form
IVD Application form for prequalification of a male circumcision device (PQMC_015 v1, 13 September 2011) DOC Application form
M Application of reference-scaled criteria for AUC in bioequivalence studies conducted for submission to PQT/MED PDF Guideline/guidance
M Applications for Finished Pharmaceutical Product (FPP) Prequalification based on Technology Transfer (TT) PDF Guideline/guidance
M Artemisinin derivatives: summary of nonclinical safety data (24 January 2016) PDF Guideline/guidance
M Assessment of response to position paper "WHO response to the USFDA warning letter issued to Mylan Laboratories Ltd, Nashik" PDF Information note
M Boas práticas da OMS para laboratórios de controle de qualidade de produtos farmacêuticos PDF Guideline/guidance
M Boas práticas da OMS para laboratórios de controle de qualidade de produtos farmacêuticos - TRS 957 - Annex 1 PDF Guideline/guidance
M BTIF - Appendix 1 - Template for Study Individual Concentration and PK Data XLSX Guideline/guidance
M Buenas prácticas de la OMS para laboratorios de control de calidad de productos farmacéuticos - TRS 957 - Annex 1 PDF Guideline/guidance
M Buenas prácticas de la OMS para laboratorios de control de calidad de productos farmacéuticos (2010) PDF Guideline/guidance
M Call for public comments on the new financing model for WHO Prequalification and supporting regulatory functions PDF Guideline/guidance
IVD CD4 Technologies: progress of the active applications in the prequalification of IVDs assessment pipeline PDF Guideline/guidance
IVD Change reporting form for a WHO-prequalified male circumcision device (PQMC_119 v1, April 2019) DOCX
IVD Change request form for a reportable changes to WHO PQ and EUL IVDs (PQDx_119 March 2025) DOCX Application form
M Clarification on the process for introducing a supplier of non-plant-derived artemisinin (1 November 2016) PDF Guideline/guidance
M Clarification with respect to a stringent regulatory organization as applicable to the stringent regulatory authority (SRA) guideline (15 February 2017) PDF Guideline/guidance
M Clinical Pharmacology & Therapeutics Journal: article on bioavailability of WHO prequalified anti-TB medicines PDF Report
M Clinical trial protocol: zinc sulphate acceptability study in children with acute diarrhoea: a prospective, open-label (multicentre) interventional study DOCX Template
M Collaboration in verification of GMP compliance between WHO-PQT and medicines manufacturers interested in submitting for WHO prequalification (16 June 2016) PDF Guideline/guidance
M Collaborative procedure between World Health Organization (WHO) and selected national medicines regulatory authorities (NMRAs) in inspection activities (16 January 2010) PDF Guideline/guidance
M Collaborative procedure between World Health Organization (WHO) and selected national medicines regulatory authorities (NMRAs) in inspection activities (Annex B): Expression of interest (18 January 2010) DOCX Application form
M Collaborative procedure between World Health Organization (WHO) and selected national medicines regulatory authorities (NMRAs) in inspection activities (Annex C): Shared inspection schedule (18 January 2010) XLSX Guideline/guidance
M Collaborative procedure between World Health Organization (WHO) and selected national medicines regulatory authorities (NMRAs) in inspection activities (Annex D): Form for nomination of an observer or co-inspector (18 January 2010) DOCX Application form
M Collaborative procedure between World Health Organization (WHO) and selected national medicines regulatory authorities (NMRAs) in inspection activities (Annex E): Details of external expert (18 January 2010) DOCX Template
M Collaborative procedure between World Health Organization (WHO) and selected national medicines regulatory authorities (NMRAs) in inspection activities (Annex F): Provisions for evaluators of product dossiers and for inspectors (18 January 2010) DOCX Application form