Past News
First FDC with dolutegravir prequalified
WHO Prequalification Team - Medicines (PQTm) added the below new products to its prequalified list:
Anhui's lamivudine/zidovudine tablet prequalified
WHO Prequalification Team - Medicines (PQTm) added the below new products to its prequalified list:
Unique's ciprofloxacin prequalified
WHO Prequalification Team - Medicines (PQTm) added the below new products to its prequalified list:
EEPI's sofosbuvir prequalified
WHO Prequalification Team - Medicines (PQTm) added the below new products to its prequalified list:
Guilin's artesunate + SP tablet prequalified
WHO Prequalification Team - Medicines (PQTm) added the below new products to its prequalified list:
Lupin's linezolid prequalified
WHO Prequalification Team - Medicines (PQTm) added the below new products to its prequalified list:
Macleods' paediatric moxifloxacin dispersible tablet prequalified
WHO Prequalification Team - Medicines (PQTm) added the below new products to its prequalified list:
Ipca's artesunate injection prequalified
WHO Prequalification Team - Medicines (PQTm) added the below new products to its prequalified list:
Emergency Use Listing Procedure - Deadline extended to 15 December 2018
DEADLINE EXTENDED TO 15 DECEMBER 2018
First generic medroxyprogesterone injection prequalified
WHO Prequalification Team - Medicines (PQTm) added the below new products to its prequalified list:
First 800mg darunavir tablet prequalified
WHO Prequalification Team - Medicines (PQTm) added the below new products to its prequalified list:
First efavirenz/lamivudine/tenofovir 400/300/300mg tablets prequalified
WHO Prequalification Team - Medicines (PQTm) added the below new products to its prequalified list:
First moxifloxacin 100mg dispersible tablets prequalified
WHO Prequalification Team - Medicines (PQTm) added the below new products to its prequalified list:
Zheijiang Hisun’s moxifloxacin tablets prequalified
WHO Prequalification Team - Medicines (PQTm) added the below new products to its prequalified list:
Micro Labs’ linezolid tablets prequalified
WHO Prequalification Team - Medicines (PQTm) added the below new products to its prequalified list:
Micro Labs’ amodiaquine/artesunate tablets prequalified
WHO Prequalification Team - Medicines (PQTm) added the below new products to its prequalified list:
Guilin’s pyrimethamine/sulfadoxine prequalified
WHO Prequalification Team - Medicines (PQTm) added the below new products to its prequalified list:
Mylan’s dolutegravir tablets prequalified
WHO Prequalification Team - Medicines (PQTm) added the below new products to its prequalified list:
Oxytocin injection - Clarification of stability data and storage statement requirements
Revised sample zinc acceptability study protocol available
WHO Prequalification provides new advice on zinc.
Updated bioequivalence and biowaiver application documents
Updated versions of the Bioequivalence Trial Information Form (BTIF) and the Application for a biowaiver: Biopharmaceutics Classification System (BCS) fo
New appendix added to Bioequivalence Trial Information (BTIF)
An appendix has been added to the Bioequivalence Trial Information Form (BTIF).
Additional bioequivalence information now required in Module 2.7
In order to improve the PQTm’s depth of knowledge regarding products submitted for prequalification and to better understand their performance as it potentially relates to safety and efficacy, PQTm
Shanghai Desano’s lamivudine/nevirapine/zidovudine tablet prequalified
WHO Prequalification Team - Medicines (PQTm) added the below new products to its prequalified list:
First dispersible sulfadoxine/pyrimethamine + amodiaquine in co-blister prequalified
WHO Prequalification Team - Medicines (PQTm) added the below new products to its prequalified list:
First valganciclovir prequalified
WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
GPO’s efavirenz tablet prequalified
WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
Capreomycin 500mg injection prequalified
WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list: