M Quality assessment training, Denmark, 18‒21 May 2014: Active pharmaceutical ingredient assessment: impurities Presentation
M Quality assessment training, Denmark, 18‒21 May 2014: Bioequivalence: general considerations and Q&A Presentation
M Quality assessment training, Denmark, 18‒21 May 2014: Good manufacturing practice issues in quality assessment Presentation
M Quality Assurance of pharmaceuticals: a compendium of guidelines and related materials. Volume 2, Second updated edition, Good manufacturing practice and inspection PDF Guideline/guidance
M Quality Information Summary (QIS) of the Biotherapeutic Product (BTP) Approved by Stringent Regulatory Authority (SRA) - QIS-BTP-SRA DOCX Guideline/guidance
M Quality Information Summary (QIS) of the Biotherapeutic Product Approved by Stringent Authority (SRA) (QIS-BTP-SRA) DOCX Guideline/guidance
M Quality Information Summary (QIS) of the Biotherapeutic Product Approved by Stringent Regulatory Authority (SRA) (QIS-BTP-SRA) DOCX Template
M Quality Information Summary (QIS) of the Finished Pharmaceutical Product (FPP) Approved by the Reference Stringent Regulatory Authority (SRA) DOCX Template
M Quality information summary (QIS) of the finished pharmaceutical product (FPP) approved by the reference stringent regulatory authority (SRA) (QIS-SRA) (28 October 2013) DOCX Template
M Quality Information Summary (QIS) of the FPP Approved by the Reference SRA for use outside of the SRA Region DOCX Template
M Recommendations on the content of a survey protocol: Survey of the quality of antimalarial medicines PDF Report
M Recommended comparator products: medicines for HIV/AIDS and related diseases PDF Guideline/guidance
M Recommended comparator products: medicines for infections in newborns and young infants and childhood pneumonia PDF Guideline/guidance
M Recommended comparator products: Treatment of bacterial infections in children PDF Guideline/guidance
M Recommended comparator products: treatment of disorders due to use of nicotine PDF Guideline/guidance
M Recommended comparator products: Treatment of multi-drug resistant bacterial infections (9 January 2024) PDF
M Règles OMS de bonnes pratiques applicables par les laboratoires de contrôle qualité pharmaceutique - TRS 957 - Annex 1 PDF Guideline/guidance
M Report on post-registration actions in respect of a product registered under the procedure, Appendix 4 PDF Template
M Report on the meeting on the survey of the quality of antimalarials in sub-Saharan Africa PDF Report
M Request for Proposals (RFP): IT support, application and data management activities to the WHO Prequalification Unit – Medicines Assessment Team PQT/MED PDF
M Request to stringent regulatory authority for permission to share stringent regulatory authority’s non-public information concerning product with the national regulatory authority/ies and the World Health Organization, Annex 3B DOCX Template
M Request to submit stability data with the submission of documentation for prequalification of finished pharmaceutical products approved by stringent regulatory authorities (1 March 2016) PDF Guideline/guidance
M Requirements for provision of a ‘bridging’ report for SRA-approved medicines for consideration of registration in non-SRA settings, Annex 8 DOCX Information note
M Requirements for stability studies of finished pharmaceutical products (29 March 2010) PDF Guideline/guidance
M Revised active pharmaceutical ingredient master file (APIMF) amendment guidance PDF Guideline/guidance
M Screening checklist for biotherapeutic products and their corresponding SBPs - Abridged Pathway DOCX Guideline/guidance
M Screening checklist for biotherapeutic products and their corresponding SBPs - Full Pathway DOCX Guideline/guidance