New WHO Public Inspection Reports (WHOPIRs) published
IS
Past News
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
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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
First pilot assessment session for in vitro diagnostics
IVD
The PQT-IVD team held a joint assessment session from 5-9 June in Geneva session to pilot a new assessment model whereby assessors meet for a week during which they work in groups to assess product
Two PQT Medicines workshops for manufacturers
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The PQT Medicines 6th Annual Medicines Quality Workshop for Manufacturers will take place from 25 to 28 September 2023.
Revised web page for Active Pharmaceutical Ingredients (APIs) published
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The Prequalification Unit (PQT) is happy to announce the introduction of a revised webpage for the List of Prequalified Active Pharmaceutical Ingredients (APIs).
2nd Invitation to Manufacturers of therapeutics against Ebola Virus Disease to submit an Expression of Interest (EOI) published
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A second Invitation to Manufacturers of therapeutics against Ebola Virus Disease to submit an Expression of Interest (EOI) for Product Evaluation to the WHO Prequalification Unit is being published
Workshop with UNDP to enhance understanding the prequalification process
IVD
The United Nations Development Programme (UNDP) procures diagnostic tests for Global Fund-supported programmes and supports Member States in accessing high-quality in vitro diagnostics (IVDs), incl
HIV focused prequalification in vitro diagnostics workshop
IVD
The Prequalification-In Vitro Diagnostics (IVD) team were invited by the US President’s Emergency Plan for AIDS Relief (PEPFAR) to present an overview of the current prequalification process for in
In vitro diagnostics assessors meeting and training
IVD
The WHO In Vitro Diagnostics (IVD) Assessment team held a meeting and trained assessors from 2 to 5 May in Geneva, Switzerland.
Newly prequalified Active Pharmaceutical Ingredient (API)
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Nirmatrelvir (WHOAPI-458) manufactured by Z
First desogestrel 75 µg tablet prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
First long-acting insulin analogues prequalified
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WHO Prequalification Unit (PQT) added the below new products to its prequalified list:
Swiss Pharma Nigeria’s dispersible zinc tablet prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
Cipla’s efavirenz/lamivudine/tenofovir 400/300/300mg tablet prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
PQT medicines will be at CPHi Shanghai - 19-21 June 2023
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The World Health Organization Prequalification Team - Medicines (PQT Medicines) will be attending the Shanghai SNIEC CPhi on 19-21 June 2023, in Shanghai, China.
Updated guidance on the development of zinc sulfate product dossiers for submission to PQT/MED
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Updated guidance on the development of zinc sulfate product dossiers for submission to PQT/MED has been posted to the PQT/MED website.