News
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.
Tocilizumab and sarilumab invited for COVID-19
Tocilizumab and sarilumab invited for COVID-19.
Macleods’ abacavir/lamivudine prequalified
WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
Medopharm’s praziquantel prequalified
WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
New artesunate injection prequalified
WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
Guilin’s artemether/lumefantrine dispersible tablets prequalified
WHO Prequalification Unit (PQT) added the below new products to its prequalified list:
S Kant’s SP dispersible tablet co-packed with amodiaquine dispersible tablet prequalified
WHO Prequalification Unit (PQT) added the below new products to its prequalified list:
S Kant’s pyrimethamine/sulfadoxine dispersible tablets prequalified
WHO Prequalification Unit (PQT) added the below new products to its prequalified list:
First albendazole prequalified
WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
Public announcement to TB in vitro diagnostics manufacturers, procurement agencies and national TB programmes on inclusion of WHO Prequalification for TB in vitro diagnostics
The World Health Organization (WHO), through its Prequalification Unit and Global Tuberculosis Programme, would like to announce future changes to the WHO procedure to determine procurement eligibi
Macleods’ 100mg isoniazid dispersible tablet prequalified
WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
First biosimilars prequalified after full assessment
WHO Prequalification Unit (PQT) added the below new products to its prequalified list:
Emcure’s dolutegravir/lamivudine/tenofovir tablet prequalified
WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
Ipca’s sulfamethoxazole/trimethoprim prequalified
WHO Prequalification Unit (PQT) added the below new products to its prequalified list: