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
M Directives de l’OMS pour la préparation d’un dossier d’information par le laboratoire - TRS 961 - Annex 13 PDF Guideline/guidance
M Directives pour la préparation d'un dossier d'information par le laboratoire (2011) PDF Guideline/guidance