M A quiet revolution in global public health: the World Health Organization's Prequalification of Medicines Programme
IVD A risk-based approach for the assessment of in vitro diagnostics (IVDs) (PQDx_152 v1, 13 May 2014) PDF
IVD Abridged prequalification assessment: prequalification of in vitro diagnostics (PQDx_173 - 8 November 2023))
M Acceptance of non-plant-derived-artemisinin offers potential to increase access to malaria treatment (issued 8 May 2013)
M Additional Guidance for Submission of the Acceptability Study for Prequalification of Zinc Tablets and Oral Liquid (Solution) PDF
M Additional guidance on submission requirements for medroxyprogesterone acetate depot injection products using the Common Technical Document (CTD) format (1 August 2015) PDF
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 (API) prequalification based upon previous stringent regulatory authority (SRA) assessment ‒ history of changes (1 May 2013) DOCX
IVD Application form for prequalification of a male circumcision device (PQMC_015 v1, 13 September 2011) DOC
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