WHO Public Assessment Reports (WHOPARs) published
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Past News
Update on N-nitrosamine impurities
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Applicants are reminded of the latest N-nitrosamines assessment policies for active pharmaceutical ingredients (APIs) and finished pharmaceutical products (FPPs):
Newly prequalified Active Pharmaceutical Ingredient (API)
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Nirmatrelvir (WHOAPI-469) manufactured by Shanghai Desano Chemical Pharmaceutical Co Ltd, has been prequalified by the WHO Prequalification Team: Medicines under its API prequalification procedure.
Ipca’s higher strength artesunate injection prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
First rifapentine generic prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
Micro Labs’ paediatric linezolid tablet prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
Laurus’ atazanavir/ritonavir tablet prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
Micro Labs’ lopinavir/ritonavir, including paediatric tablet, prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
Human Insulin Master File (h-IMF)
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Diabetes mellitus is a public health challenge due to its high and increasing prevalence and associated morbidity and mortality that have health and economic impact on ind
Resolution of Notice of Concern (NOC)
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A-31 Clinical Unit I at Accutest Research Laboratories (I) Pvt. Ltd has addressed the concerns highlighted in the Notice of Concern (NOC) by the WHO.
Guilin’s pyrimethamine/sulfadoxine dispersible tablet prequalified
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WHO Prequalification Unit (PQT) added the below new products to its prequalified list:
Universal’s pyrimethamine/sulfadoxine + amodiaquine dispersible tablet prequalified
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WHO Prequalification Unit (PQT) added the below new products to its prequalified list:
PQT/MED publishes first invitation to manufacturers of medicinal products for treatment of disorders caused by use of tobacco, to submit an Expression of Interest (EOI)
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A first invitation to manufacturers of medicinal products for treatment of disorders caused by use of tobacco, to submit an Expression of Interest (EOI) for product evaluation
Malaria Rapid Diagnostic Tests: Intended Use Statement
IVD
The In Vitro Diagnostics Assessment Team acknowledges that there have been inconsistencies in the intended use statements presented in various Instructions for Use (IFUs) of prequalified malaria Ra
First oral zinc solution prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
PharmEvo’s dispersible zinc tablet prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
Newly prequalified Active Pharmaceutical Ingredient (API)
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Molnupiravir (WHOAPI-
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.