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
The PQT/AMD team has added a new product to the Emergency Use Listing (EUL):
WHO's Public Assessment Reports (WHOPARs) Updates
IVD
During the week of 20–24 October 2025, the World Health Organization (WHO) published updates to several WHO’s Public Assessment Reports (WHOPARs) on its In Vitro Diagnostics (IV
EUL listing of an additional MPXV test
IVD
In a continuing effort to best support the MPXV response, the Prequalification Unit has listed the Monkeypox Virus
WHO has listed an additional TB test
IVD
The World Health Organization (WHO) has prequalified the Xpert MTB/XDR test, a quality-assured molecular diagnostic tool that enables rapid drug susceptibility testing (DST) for tuberculosis (TB).
Additional HPV tests listing
IVD
WHO has prequalified two more products:
The BD Onclarity™ HPV Assay for the BD COR™ System is an amplified DNA test for the qualitative dete
Training for IVDs assessors for WHO Prequalification WHO Academy Lyon, 7-9 October 2025
IVD