M 22nd Invitation for Expression of Interest (EOI) for medicines against HIV infection and related diseases to submit an expression of interest (EOI) for product evaluation to the WHO Prequalification Unit PDF Guideline/guidance
M 22nd Invitation to manufacturers of antimalarial medicines to submit an expression of interest (EOI) for product evaluation to the WHO Prequalification Unit PDF Guideline/guidance
M 22nd Invitation to Manufacturers of Antituberculosis Medicines to submit an Expression of Interest (EOI) for product evaluation to the WHO Prequalification Unit PDF Guideline/guidance
M 23rd Invitation for Expression of Interest (EOI) for medicines against HIV infection and related diseases to submit an expression of interest (EOI) for product evaluation to the WHO Prequalification Unit PDF Guideline/guidance
M 2nd Invitation to Manufacturers of Human Insulin to Submit an Expression of Interest (EOI) for Product Evaluation to the WHO Prequalification Team - Biotherapeutic Products (BTPs) PDF Guideline/guidance
M 2nd Invitation to Manufacturers of therapeutics against Ebola Virus Disease to submit an Expression of Interest (EOI) for Product Evaluation to the WHO Prequalification Unit PDF Guideline/guidance
M 2nd Invitation to manufacturers of zinc products to submit an expression of interest (EOI) for product evaluation to the WHO Prequalification Team: medicines (23 January 2025) PDF Guideline/guidance
M 39th Invitation to manufacturers of active pharmaceutical ingredients (APIs) to submit an expression of interest (EOI) for API evaluation to the WHO Prequalification Unit PDF Guideline/guidance
M 3rd Biotherapeutic Product (BTP) and Similar Biotherapeutic Product (SBP) assessment training (Virtual) - 14 June 2024 - Agenda PDF
M 3rd Biotherapeutic Product (BTP) and Similar Biotherapeutic Product (SBP) assessment training (Virtual) - 14 June 2024 - AGENDA PDF
M 3rd Invitation to quality control laboratories (QCLs) to submit an expression of interest for prequalification to the WHO Prequalification Team: medicines (1 June 2011) PDF Guideline/guidance
M 4th Annual PQT Medicines Biotherapeutic Product (BTP) and Similar Biotherapeutic Product (SBP) assessment training - 13 June 2025 (virtual) PDF
M 4th Invitation to manufacturers of influenza-specific antiviral medicines to submit an expression of interest for product evaluation to the WHO Prequalification Team: medicines (August 2024) PDF Guideline/guidance
M 5th Invitation to manufacturers of medicinal products for treatment of hepatitis B and C to submit an expression of interest (EOI) for product evaluation to the WHO Prequalification Team: medicines PDF Guideline/guidance
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
IVD A risk-based approach for the assessment of in vitro diagnostics (IVDs) (PQDx_152 v1, 13 May 2014) PDF Guideline/guidance
IVD Abridged prequalification assessment: prequalification of in vitro diagnostics (PQDx_173_v5_8 Nov 2023) Guideline/guidance
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