M Frequently Asked Questions (FAQ) - WHO Pilot Procedure for Prequalification of Biotherapeutic Products: rituximab and trastuzumab PDF Guideline/guidance
M Frequently asked questions by the manufacturing, trial and testing organizations in connection with some of their constraints faced during the COVID-19 outbreak PDF Information note
M Guidance - Nitrosamine contamination policy for Active Pharmaceutical Ingredients PDF Guideline/guidance
M 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 Guideline/guidance
M Guidance on plain language descriptions of visual appearance for oral dosage forms in WHOPARs PDF Guideline/guidance
M Guidance on the Submission of Applications for Prequalification of Zinc Tablets and Zinc Oral Liquid (Solution) PDF Guideline/guidance
M V Guidelines for good clinical practice (GCP) for trials on pharmaceutical products - TRS 850 PDF Guideline/guidance
IVD M HIV market report: the state of HIV treatment, testing and preventing in low- and middle-income countries (CHAI, September 2020) PDF Report
M HIV mid-year market memo, 2018 20 June 2018 (Clinton Health Access Initiative) PDF Information note
M ICHQ3D and Finished Pharmaceutical Products (FPPs) prequalification procedures PDF Guideline/guidance
ID IVD M V VCP Impact assessment of WHO prequalification and systems supporting activities (June 2019) PDF Report
M Information on the GMP status of Micro Labs Kumbalgodu (ML08) manufacturing facility PDF Information note
M Joint UNICEF & WHO meeting with manufacturers and suppliers, Denmark, 24‒26 September 2012: Programme description
M Joint UNICEF, UNFPA & WHO meeting with manufacturers and suppliers 14–27 September 2018: Agenda PDF Information note
ID IVD IS M V VCP Joint UNICEF, UNFPA & WHO meeting with manufacturers and suppliers 18–21 September 2017: Agenda PDF Information note
M Joint UNICEF, UNFPA & WHO meeting with manufacturers and suppliers 18–21 September 2017: Programme description PDF Information note
ID IVD M V VCP Joint UNICEF, UNFPA & WHO meeting with manufacturers and suppliers 2–5 December 2019: Agenda PDF Information note
M Joint UNICEF, UNFPA & WHO meeting with manufacturers and suppliers 24–27 September 2018: Programme description PDF Information note
M Joint UNICEF, UNFPA & WHO meeting with manufacturers and suppliers, Denmark, 18‒21 September 2017: Background for WHO vector control prequalification PDF Information note
M Joint UNICEF, UNFPA & WHO meeting with manufacturers and suppliers, Denmark, 18‒21 September 2017: Funding for WHO/UNFPA prequalification of condoms and intrauterine devices PDF Presentation
M Joint UNICEF, UNFPA & WHO meeting with manufacturers and suppliers, Denmark, 18‒21 September 2017: WHO vaccines prequalification overview: vaccines assessment PDF Presentation
M Linepharma France's Hemoprostol (misoprostol) included in the prequalified list PDF Guideline/guidance
M Marketing authorization of pharmaceutical products with special reference to multisource (generic) products: a manual for drug regulatory authorities PDF Guideline/guidance
M Model letter of access: active pharmaceutical ingredient master file (APIMF) (14 February 2016) DOCX Template
M National regulatory authority participation agreement and undertaking for national regulatory focal point(s), Appendix 1, Part A PDF Template