40th Invitation of Active Pharmaceutical Ingredients (APIs)
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The following API was deleted:
First primaquine dispersible tablets prequalified
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WHO Prequalification Unit (PQT) added the below new products to its prequalified list:
WHO's Public Assessment Reports (WHOPARs) Updates
IVD
WHO’s Prequalification of In Vitro Diagnostics
During the week of 27–31 October 2025, the World Health Organization (WHO) publ
EUL Listing: MPXV IVD
IVD
Cowingene Monkeypox Typing Detection Kit, manufactured by Taizhou Cowingene Biotech Co., Ltd., has been listed under the WHO Emergency Use Listing (EUL).
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Two HPV assays have been prequalified
IVD
These assays - Aptima HPV 16 18/45 Genotype Assay and the Aptima HPV Assay provide advanced nucleic acid amplification technology for detecting high-risk HPV type
Update on Nitrosamine Impurities
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In September 2023, PQT/MED issued a call to manufacturers to revisit and update their risk assessments for Finished Pharmaceutical Products (FPP) containing APIs with vulnerable amine groups.
New EUL Listing: MPXV IVD
IVD