19th Invitation to manufacturers of antimalarial medicines to submit an expression of interest (EOI) for product evaluation to the WHO Prequalification Unit pdf
19th Invitation to manufacturers of medicinal products for HIV infection and related diseases to submit an expression of interest (EOI) for product evaluation to the WHO Prequalification Unit pdf
1st Invitation to laboratories to submit an expression of interest (23 May 2016) pdf
1st Invitation to Manufacturers of Biotherapeutic Products (BTPs) and Similar Biotherapeutic Products (SBPs)to Submit an Expression of Interest (EOI) for Product Evaluation to the WHO Prequalification Team - Biotherapeutic Products (BTPs) pdf
1st 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
1st Invitation to manufacturers of medicinal products for treatment of infections in newborn and young infants and childhood pneumonia, to submit an Expression of Interest (EOI) for product evaluation to the WHO Prequalification Unit pdf
1st Invitation to manufacturers of zinc products to submit an expression of interest (EOI) for product evaluation to the WHO Prequalification Team: medicines (10 November 2016) pdf
21st Invitation to Manufacturers of Antituberculosis Medicines to submit an Expression of Interest (EOI) for product evaluation to the WHO Prequalification Unit pdf
24th Invitation to manufacturers of active pharmaceutical ingredients (APIs) to submit an expression of interest (EOI) for API evaluation to the WHO Prequalification Unit pdf
3rd Invitation to manufacturers of influenza-specific antiviral medicines to submit an expression of interest for product evaluation to the WHO Prequalification Team: medicines (3 July 2015) pdf
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
4th 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 (4 April 2017) pdf
Updated 4th Invitation to manufacturers of therapeutics against COVID-19 to submit an Expression of Interest (EOI) for product evaluation to the WHO Prequalification Unit pdf
7th 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
9th Invitation to manufacturers of reproductive health products to submit an expression of interest (EOI) for product evaluation to the WHO Prequalification Team: medicines pdf
A risk-based approach for the assessment of in vitro diagnostics (IVDs) (PQDx_152 v1, 13 May 2014) pdf
Updated Abridged Prequalification Assessment (PQDx 173 - 04 January 2021) pdf
Addendum – Evaluation of Modified COVID-19 Vaccines pdf
Additional guidance for submission of the acceptability study for prequalification of zinc tablets and oral liquid (solution) (25 September 2018) pdf
Additional guidance on submission requirements for medroxyprogesterone acetate depot injection products using the Common Technical Document (CTD) format (1 August 2015) pdf
Advice on the selection of excipients for zinc tablets and solutions (10 November 2016) pdf
Advice to manufacturers (10 October 2016) pdf
Application of reference-scaled criteria for AUC in bioequivalence studies conducted for submission to PQT/MED pdf
Applications for Finished Pharmaceutical Product (FPP) Prequalification based on Technology Transfer (TT) pdf
Artemisinin derivatives: summary of nonclinical safety data (24 January 2016) pdf
Boas práticas da OMS para laboratórios de controle de qualidade de produtos farmacêuticos pdf
BTIF - Appendix 1 - Template for Study Individual Concentration and PK Data xlsx
Buenas prácticas de la OMS para laboratorios de control de calidad de productos farmacéuticos (2010) pdf
Clarification on the process for introducing a supplier of non-plant-derived artemisinin (1 November 2016) pdf
Clarification with respect to a stringent regulatory organization as applicable to the stringent regulatory authority (SRA) guideline (15 February 2017) pdf
Coartem Basic Patient Leaflet pdf
Collaboration in verification of GMP compliance between WHO-PQT and medicines manufacturers interested in submitting for WHO prequalification (16 June 2016) pdf
Collaborative procedure between World Health Organization (WHO) and selected national medicines regulatory authorities (NMRAs) in inspection activities (16 January 2010) pdf
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
Collaborative procedure between World Health Organization and selected national medicines regulatory authorities in inspection activities (Annex A): Invitation to participate (January 2010) docx
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
Comirnaty Product Information pdf
Common Deficiencies in Finished Pharmaceutical Product (FPP) Dossiers - Additional Guidance to Manufacturers pdf
Confidentiality Undertaking by National Regulatory Authorities pdf
Considerations for the Assessment of COVID-19 Vaccines for Listing by WHO pdf
Coordination between WHO Living Guidelines and WHO EUL and PQ processes for Therapeutics in the context of COVID-19 pdf
COR-WHO-Adu-10 syringes-insert pdf
COR-WHO-Adu-40 vials-insert pdf
New Coronavirus disease (COVID-19) pandemic Product specific requirements for currently invited combination of casirivimab and imdevimab pdf
Coronavirus disease (COVID-19) pandemic Product specific requirements for currently invited IL-6 inhibitors (tocilizumab and sarilumab) pdf
Directives pour la préparation d'un dossier d'information par le laboratoire (2011) pdf
DRAFT TSS 10 In vitro diagnostic (IVD) medical devices used for the qualitative and quantitative detection of hepatitis C RNA — to be published shortly — draft document pdf
DRAFT TSS 11 In vitro diagnostic (IVD) medical devices used for the quantitative detection of HIV-1 nucleic acid — to be published shortly — draft document pdf
DRAFT TSS 12 In vitro diagnostic (IVD) medical devices used for the qualitative detection of HIV-1 and HIV-2 nucleic acid — to be published shortly — draft document pdf
DRAFT TSS 13 Rapid diagnostic tests to detect hepatitis B surface antigen — to be published shortly pdf
DRAFT TSS 14 Immunoassays to detect hepatitis B virus surface antigen — to be published shortly pdf
DRAFT TSS 15 In vitro diagnostic (IVD) medical devices used for the quantitative detection of hepatitis B nucleic acid — to be published pdf
DRAFT TSS 9 Immunoassays to detect HIV antibody and/or antigen — to be published shortly pdf
Draft: Instructions for compilation of a product dossier ‒ IMDRF ToC (PQDx_018, 21 March 2020) pdf
E001 product dossier checklist xlsx
E003 product dossier checklist xlsx
E004 product dossier checklist xlsx
E006 product dossier checklist xlsx
E007 product dossier checklist xlsx
Emergency Use Assessment and Listing Procedure (EUAL) for candidate in vitro diagnostics (IVDs) for use in the context of a public health emergency (7 July 2015) pdf
Emergency Use Listing Procedure (EUL) (13 December 2020) pdf
Engagement de Confidentialité des Autorités Nationales de Réglementation pdf
Example of a completed application for a new version of an active pharmaceutical ingredient master file (APIMF) (23 May 2017) pdf
Example of a completed application for an amendment to an active pharmaceutical ingredient master file (APIMF) (3 March 2016) pdf
Example of information included in the list of participating SRAs, Annex 2 pdf
FAQ: Active pharmaceutical ingredient (API) micronization (13 September 2019) pdf
FAQ: Active pharmaceutical ingredient master file (APIMF) amendments (15 April 2015) pdf
Chinese, Simplified
FAQ: Active pharmaceutical ingredient master files (APIMFs) (15 April 2015) pdf
FAQ: EUL assessment of IVD to detect SARS-CoV-2 or anti-SARS-CoV-2 antibodies pdf
FAQ: Variations to prequalified pharmaceutical products pdf
First Invitation to manufacturers of vaccines against Covid-19 to submit an Expression of Interest (EOI) for evaluation by the WHO (Prequalification and/or EUL) pdf
Frequent Deficiencies in Bioequivalence Study Protocols pdf
Frequently Asked Questions (FAQ) - WHO Pilot Procedure for Prequalification of Biotherapeutic Products: rituximab and trastuzumab pdf
Generic field evaluation checklist for PQS reviewers pdf
Generic guide for the field evaluation of new technologies for WHO PQS prequalification GENERIC/GUIDE 1.1 pdf
Generic Risk Assessment-Human Health: ITNs formulated with Alpha-cypermethrin pdf
Generic Risk Assessment-Human Health: ITNs formulated with Deltamethrin pdf
Generic Risk Assessment-Human Health: ITNs formulated with Permethrin pdf
Generic Risk Assessment-Human Health: ITNs formulated with Piperonyl-Butoxide pdf
Guidance for the prequalification of single-phase voltage stabilizers: E007/VS pdf
Guidance on amendments to an active pharmaceutical ingredient master file (APIMF) submitted in support of a prequalified finished pharmaceutical product (FPP) or prequalified API (18 October 2019) pdf
Guidance on bioequivalence studies for reproductive health medicines pdf
Guidance on variations to a prequalified vaccine pdf
Handbook for good clinical research practice: guidance for implementation pdf
HIV/Syphilis Combo Rapid Tests: progress of the active applications in the prequalification of IVDs assessment pipeline pdf
ICHQ3D and Finished Pharmaceutical Products (FPPs) prequalification procedures pdf
Information for manufacturers on the inspection of manufacturing sites: Prequalification of male circumcision devices (PQDx_014 V4, Version MC_0, 15 November 2012) pdf
Instructions and requirements for Emergency Use Listing (EUL) submission: In vitro diagnostics detecting antibodies to SARS-CoV-2 virus pdf
Instructions and requirements for Emergency Use Listing (EUL) submission: In vitro diagnostics detecting SARS-CoV-2nucleic acidandrapid diagnostics tests detecting SARS-CoV-2 antigens pdf
Instructions for compilation of a product dossier (PQMC_018 v1, 23 January 2012) pdf
Instructions for submission requirements: in vitro diagnostics (IVDs) detecting antibodies to Zika virus (PQDx_239 v4, 28 October 2016) pdf
Instructions for submission requirements: in vitro diagnostics (IVDs) detecting Zika virus nucleic acid or antigen (DxPQ_240 version 3, 24 October 2016) pdf
Instructions for the completion of the application form (PQMC_017 v1, 13 September 2011) pdf
Interagency finished pharmaceutical products questionnaire docx
Introducing solar-powered vaccine refrigerator and freezer systems pdf
Invitation to manufacturers of in vitro diagnostics for SARS-CoV-2 to submit an application for emergency use listing by WHO pdf
Janssen EVD vaccine roadmap pdf
Labelling Review for Prequalification Assessment (PQDx 361 v1) pdf
Marketing authorization of pharmaceutical products with special reference to multisource (generic) products: a manual for drug regulatory authorities pdf
Model letter of requalification (20 September 2018) pdf
