M Call for public comments on the new financing model for WHO Prequalification and supporting regulatory functions PDF
IVD CD4 Technologies: progress of the active applications in the prequalification of IVDs assessment pipeline PDF
IVD Change reporting form for a WHO-prequalified male circumcision device (PQMC_119 v1, April 2019) DOCX
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
M Common Deficiencies in Finished Pharmaceutical Product (FPP) Dossiers - Additional Guidance to Manufacturers PDF
M Concept note: Requirements for provision of a ‘bridging’ report for SRA-approved medicines for consideration of registration in non-SRA settings DOCX
V Consent of applicants/manufacturers of a vaccine or a pharmaceutical product, diagnostics and vaccines for WHO to share information with the national regulatory authority(ies) confidentially in Emergency Situations DOCX
M Consent of WHO prequalification holder for WHO to share information with the national regulatory authority confidentially under the procedure, Appendix 2 PDF
VCP Considerations for fulfilling the acute 6-pack requirement for insecticide-treated nets (VCP Advice to manufacturers series) PDF
IVD Consultation on the documentary evidence and independent performance evaluation requirements for the Emergency Use Assessment and Listing procedure for Zika virus in vitro diagnostics, March 2016 PDF
M Coordination between WHO Living Guidelines and WHO EUL and PQ processes for Therapeutics in the context of COVID-19 PDF
M Coronavirus disease (COVID-19) pandemic Product specific requirements for currently invited combination of casirivimab and imdevimab PDF
M Coronavirus disease (COVID-19) pandemic Product specific requirements for currently invited IL-6 inhibitors (tocilizumab and sarilumab) PDF