M Call for public comments on the new financing model for WHO Prequalification and supporting regulatory functions PDF Guideline/guidance
IVD CD4 Technologies: progress of the active applications in the prequalification of IVDs assessment pipeline PDF Guideline/guidance
IVD Change reporting form for a WHO-prequalified male circumcision device (PQMC_119 v1, April 2019) DOCX
IVD Change request form for a reportable changes to WHO PQ and EUL IVDs (PQDx_119 March 2025) DOCX Application form
M Clarification on the process for introducing a supplier of non-plant-derived artemisinin (1 November 2016) PDF Guideline/guidance
M Clarification with respect to a stringent regulatory organization as applicable to the stringent regulatory authority (SRA) guideline (15 February 2017) PDF Guideline/guidance
M Clinical Pharmacology & Therapeutics Journal: article on bioavailability of WHO prequalified anti-TB medicines PDF Report
M Clinical trial protocol: zinc sulphate acceptability study in children with acute diarrhoea: a prospective, open-label (multicentre) interventional study DOCX Template
M Collaboration in verification of GMP compliance between WHO-PQT and medicines manufacturers interested in submitting for WHO prequalification (16 June 2016) PDF Guideline/guidance
M Collaborative procedure between World Health Organization (WHO) and selected national medicines regulatory authorities (NMRAs) in inspection activities (16 January 2010) PDF Guideline/guidance
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 Application form
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 Guideline/guidance
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 Application form
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 Template
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 Application form
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 Template
M Collaborative procedure between World Health Organization and selected national medicines regulatory authorities in inspection activities (Annex A): Invitation to participate (January 2010) DOCX Guideline/guidance
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 Guideline/guidance
M Common Deficiencies in Finished Pharmaceutical Product (FPP) Dossiers - Additional Guidance to Manufacturers PDF Guideline/guidance
M Concept note: Requirements for provision of a ‘bridging’ report for SRA-approved medicines for consideration of registration in non-SRA settings DOCX Information note
V Confidentiality undertaking by national regulatory authorities for Mpox products DOCX Guideline/guidance
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 Application form
M Consent of WHO prequalification holder for WHO to share information with the national regulatory authority confidentially under the procedure, Appendix 2 PDF Template
VCP Considerations for fulfilling the acute 6-pack requirement for insecticide-treated nets (VCP Advice to manufacturers series) PDF Guideline/guidance
VCP Considerations for post-market surveillance of WHO prequalified insecticide treated nets PDF Guideline/guidance
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 Report
M Coordination between WHO Living Guidelines and WHO EUL and PQ processes for Therapeutics in the context of COVID-19 PDF Guideline/guidance
M Coronavirus disease (COVID-19) pandemic Product specific requirements for currently invited combination of casirivimab and imdevimab PDF Guideline/guidance
M Coronavirus disease (COVID-19) pandemic Product specific requirements for currently invited IL-6 inhibitors (tocilizumab and sarilumab) PDF Guideline/guidance