New WHO Public Inspection Reports (WHOPIRs) published
IS
Strengthening the Quality Management System for Manufacturers of Local Medical Device through WHO Prequalification (WHO-PQ)
IVD
In collaboration with the WHO Indonesia Country Office the PQT-IVD Team contributed to a workshop hosted by the Directorate of Pharmaceutical and Medical Devices Resilience, Ministry of Health, Ind
First prequalified artesunate injectable presented with a single solvent system
M
WHO Prequalification Unit (PQT) added the below new products to its prequalified list:
Celltrion’s dolutegravir/lamivudine/tenofovir tablet prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
PQ-IVD Technical Specifications: Consultation for IVDs to detect SARS-CoV-2 nucleic acid (closed systems and open platforms) and rapid diagnostic tests (RDTs) to detect SARS-CoV-2 antigen for professional use and/or self-testing
IVD
WHO has been developing PQ technical specifications for IVDs to detect SARS-CoV-2 nucleic acid (closed systems and open platforms) and
PQ-IVD Technical Specifications: Consultation for hemoglobin POC analyzers and revision of malaria RDTs performance study requirements
IVD
The PQT In Vitro Diagnostics Assessment team held a two day consultation meeting with experts in Geneva to review and finalize proposed performance study requirements for WHO prequalification