Report on the review of regulatory flexibilities/agilities as implemented by National Regulatory Authorities during Covid-19 pandemic
See full report:
See full report:
A nitrosamine impurity, 1-methyl-4-nitrosopiperazine (MeNP), was identified in rifampicin products.
A 1st 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 by
Casirivimab and imdevimab combination invited for COVID-19.
Tocilizumab and sarilumab invited for COVID-19.
On 05 February 2021, Gilead Sciences Ltd.
On 13 November 2020, WHO listed the nOPV2 vaccine (Bio Farma, Indonesi
WHO Prequalification Unit - Medicines Assessment Team (PQT/MED) has been in contact with Sanofi regarding the presence of 1-cyclopentyl-4-nitrosopiperazine (CPNP) in their tuberculosis treatment -
Nitrosamine impurities have been identified in rifapentine and rifampicin products.