News
Nitrosamine concerns in rifampicin products - Update
A nitrosamine impurity, 1-methyl-4-nitrosopiperazine (MeNP), was identified in rifampicin products.
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 published
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
DEMO’s dexamethasone solution for injection prequalified
WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
First generic flucytosine tablet prequalified
WHO Prequalification Unit (PQT) added the below new products to its prequalified list:
WHO list of prequalified in vitro diagnostic products updated
The WHO list of prequalified in vitro diagnostic products has been updated.
Casirivimab and imdevimab combination invited for COVID-19
Casirivimab and imdevimab combination invited for COVID-19.
Protionamide tablet from Lekhim Joint Stock Company in Ukraine prequalified
WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
Remington’s levofloxacin tablet prequalified
WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
Lupin’s paediatric isoniazid/rifampicin dispersible tablet prequalified
WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
Application of reference-scaled criteria for AUC in bioequivalence studies conducted for submission to PQT/MED
WHO bioequivalence guidelines (TRS No.
First dolutegravir 5mg dispersible tablet prequalified
WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
First darunavir/ritonavir tablet prequalified
WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
Lab Liconsa’s ivermectin prequalified
WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
Naari’s levonorgestrel tablet prequalified
WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
Panpharma’s oxytocin injection prequalified
WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
Tunggal’s medroxyprogesterone acetate depot injection prequalified
WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
Macleods’ dispersible sulfadoxine/pyrimethamine tablet prequalified
WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
New Invitation for Expression of Interest (EOI) to manufacturers of antituberculosis medicines published
The Invitation to Manufacturers of Antituberculosis Medicines to submit an Expression of Interest for Product Evaluation to the WHO Prequalification Unit was recently updated following a request by
Two PQT Medicines workshops for manufacturers: The 4th Annual Quality Workshop for Manufacturers and the 1st Biotherapeutics Workshop for Manufacturers
For further information see: /prequal/events/two-pqt-medicines-workshops-manufacturers
ICH Harmonised Guideline M9 “Biopharmaceutics Classification System-Based Biowaivers” implemented and updated biowaiver documentation published
Effective 25 May 2021 the ICH guideline M9 “Biopharmaceutics Classification System-Based Biowaivers” is implemented by PQT/MED.