VCP Preparation of entomology study reports - Annex III. Larvicide studies (VCP Advice to manufacturers series) PDF Guideline/guidance
VCP Preparation of entomology study reports - Annex IV. Space spray studies (VCP Advice to manufacturers series) PDF Guideline/guidance
VCP Preparation of entomology study reports (VCP Advice to manufacturers series) PDF Guideline/guidance
VCP Preparing an application for electronic submission (VCP Advice to manufacturers series) PDF Guideline/guidance
M Préqualification des laboratories de contrôle de qualité. Procédure d'evaluation de l'acceptabilité, de principe, des laboratoires de contrôle qualité à l'usage des institutions des Nations Unies PDF Guideline/guidance
IVD Prequalification fees for male circumcision devices (PQMC v1, 15 April 2019) PDF Guideline/guidance
M Principles for prioritizing dossiers within the WHO Prequalification Team: medicines (27 October 2011) PDF Information note
IVD Priority Categorization of Applications for Prequalification (PQ) and Emergency Use Listing (EUL) Assessments of in vitro diagnostics PDF Guideline/guidance
M Procedure to enable national registration of products prequalified based on SRA approval through CRP-18-March-2025 PDF Guideline/guidance
M Procedure to enable prequalification products approved by SRAs for use outside the SRA region-18 March 2025 PDF Guideline/guidance
M Product Recall - Moxifloxacin 100mg Dispersible Tablets (TB342): Batch BMC5801A PDF Information note
VCP Product Review Report - Insecticide Treated Nets Formulated with Pyrethroid+PBO and Pyrethroid+2ndActive PDF Report
IVD Protocol for the evaluation of nucleic acid tests for the diagnosis of tuberculosis (TB NAT) Guideline/guidance
IVD Protocol for the performance evaluation of nucleic acid tests for the quantitative detection of hepatitis B virus DNA for WHO prequalification assessment V 1.1 Nov 2023 Guideline/guidance
IVD Protocol for the performance evaluation of rapid diagnostic tests for the detection of Vibrio cholerae O1 or O1/O139 for WHO prequalification assessment V 2.2 Nov 2023 Guideline/guidance
IVD Public announcement to TB in vitro diagnostics manufacturers, procurement agencies and national TB programmes on inclusion of WHO Prequalification for TB in vitro diagnostics PDF Advocacy material
M Public consultation on proposed financing model for WHO prequalification: summary of responses received Application form
M Public consultation on proposed financing model for WHO prequalification: summary of responses received (issued 2 June 2015) PDF Report
IVD Public Report for Alinity m MPXV AMP Kit and Alinity m MPXV CTRL Kit, (MPXV 12644-027-00) PDF Report
M Q&A: Submission of applications for prequalification of magnesium sulfate injection (6 October 2014) PDF Guideline/guidance
M Quality assessment training, Denmark, 18-21 May 2014: Prequalification overview and update Presentation
M Quality assessment training, Denmark, 18‒21 May 2014: Active pharmaceutical ingredient assessment: impurities Presentation
M Quality assessment training, Denmark, 18‒21 May 2014: Bioequivalence: general considerations and Q&A Presentation
M Quality assessment training, Denmark, 18‒21 May 2014: Good manufacturing practice issues in quality assessment Presentation
M Quality Assurance of pharmaceuticals: a compendium of guidelines and related materials. Volume 2, Second updated edition, Good manufacturing practice and inspection PDF Guideline/guidance
M Quality Information Summary (QIS) of the Biotherapeutic Product (BTP) Approved by Stringent Regulatory Authority (SRA) - QIS-BTP-SRA DOCX Guideline/guidance