M Agenda - PQT Medicines 5th Annual Medicines Quality Workshop for Manufacturers - 26-29 September 2022
M Application for active pharmaceutical ingredient (API) prequalification based upon previous stringent regulatory authority (SRA) assessment ‒ history of changes (1 May 2013) DOCX
M Application of reference-scaled criteria for AUC in bioequivalence studies conducted for submission to PQT/MED PDF
M Applications for Finished Pharmaceutical Product (FPP) Prequalification based on Technology Transfer (TT) PDF
M Assessment of response to position paper "WHO response to the USFDA warning letter issued to Mylan Laboratories Ltd, Nashik" PDF
M Boas práticas da OMS para laboratórios de controle de qualidade de produtos farmacêuticos - TRS 957 - Annex 1 PDF
M Buenas prácticas de la OMS para laboratorios de control de calidad de productos farmacéuticos - TRS 957 - Annex 1 PDF
M Buenas prácticas de la OMS para laboratorios de control de calidad de productos farmacéuticos (2010) PDF
M Call for public comments on the new financing model for WHO Prequalification and supporting regulatory functions PDF
M Clarification on the process for introducing a supplier of non-plant-derived artemisinin (1 November 2016) PDF
M Clarification with respect to a stringent regulatory organization as applicable to the stringent regulatory authority (SRA) guideline (15 February 2017) PDF
M Clinical Pharmacology & Therapeutics Journal: article on bioavailability of WHO prequalified anti-TB medicines PDF
M Clinical trial protocol: zinc sulphate acceptability study in children with acute diarrhoea: a prospective, open-label (multicentre) interventional study DOCX
M Collaboration in verification of GMP compliance between WHO-PQT and medicines manufacturers interested in submitting for WHO prequalification (16 June 2016) PDF
M Collaborative procedure between World Health Organization (WHO) and selected national medicines regulatory authorities (NMRAs) in inspection activities (16 January 2010) PDF
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
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
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
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
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
M Collaborative procedure between World Health Organization (WHO) and selected national medicines regulatory authorities (NMRAs) in inspection activities (Annex G): Appointment as an observer or co-inspector in a WHO inspection team (18 January 2010) PDF
M Collaborative procedure between World Health Organization and selected national medicines regulatory authorities in inspection activities (Annex A): Invitation to participate (January 2010) DOCX
M Collaborative procedure between World Health Organization and selected national medicines regulatory authorities in inspection activities (Annex H): Appointment of observer or co-inspector: template letter to supervisor (18 January 2010) PDF