News
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:
Newly prequalified Active Pharmaceutical Ingredient (API)
Tenofovir disoproxil fumarate (
Newly prequalified Quality Control Laboratories (QCLs)
New addition to the List of Prequalified Quality Control Laboratories (QCLs):
Note on paediatric products in PQT Medicines
The development of paediatric formulations for essential medicines has been recognized as a critical step for successful healthcare delivery.
First Itraconazole prequalified
WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
First paediatric cycloserine prequalified
WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
First generic rifampicin 300mg capsule
WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
Dolutegravir 50mg prequalified
WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
Newly prequalified Active Pharmaceutical Ingredient (API)
Praziquantel (WHOAPI-309) manufactured by Shanghai Desano Chemical Pharmaceutical Co Ltd has been prequalified by the WHO Prequalification Team: medicines under its AP
WHO kick-starts pilot prequalification of biotherapeutics for cancer treatment
WHO today launches a pilot project for prequalifying biotherapeutic medicines, a step towards making some of the most expensive treatments for cancer more widely available in low- and middle-income
Newly prequalified Active Pharmaceutical Ingredients (APIs)
Linezolid (WHOAPI-252) and Kanamycin (acid