M 8th Invitation to manufacturers of therapeutics against COVID-19 to submit an Expression of Interest (EOI) for product evaluation to the WHO Prequalification Unit PDF Guideline/guidance
M 9th Invitation to manufacturers of medicinal products for the treatment of neglected tropical diseases to submit an expression of interest (EOI) for product evaluation to the WHO Prequalification Unit PDF Guideline/guidance
M A quiet revolution in global public health: the World Health Organization's Prequalification of Medicines Programme Advocacy material
M Acceptance of non-plant-derived-artemisinin offers potential to increase access to malaria treatment (issued 8 May 2013) Information note
M Additional Guidance for Submission of the Acceptability Study for Prequalification of Zinc Tablets and Oral Liquid (Solution) PDF Guideline/guidance
M Additional guidance on submission requirements for medroxyprogesterone acetate depot injection products using the Common Technical Document (CTD) format (1 August 2015) PDF Guideline/guidance
M Agenda - PQT Medicines 2nd Biotherapeutic Product (BTP) and Similar Biotherapeutic Product (SBP) Workshop for Manufacturers – 30 September 2022
M Agenda - PQT Medicines 5th Annual Medicines Quality Workshop for Manufacturers - 26-29 September 2022
M Application for Active Pharmaceutical Ingredient Master File (APIMF) eCTD Baseline Amendment DOCX Application form
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 Finished Pharmaceutical Product (FPP) eCTD Baseline Variation DOCX Application form
M Application for prequalification of an active pharmaceutical ingredient (API) DOCX Application form
M Application for prequalification of an active pharmaceutical ingredient (API-abridged) DOCX 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
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