News
Question & Answer - COVID-19 and WHO PQT Inspections
On 30 January 2020, WHO Director-General, Dr Tedros Ghebr
Laboratorios Leon Pharma’s levonorgestrel/ethinylestradiol tablet prequalified
WHO Prequalification Unit (PQT) added the below new products to its prequalified list:
Emcure’s emtricitabine/tenofovir tablet prequalified
WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
WHO Prequalification Unit – Medicines request to manufacturers to conduct risk assessments to evaluate the potential for the presence of nitrosamine impurities
Background
Medicine Regulatory Authorities firs
First meropenem prequalified
WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
Strides’ sofosbuvir 400 mg tablet prequalified
WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
Emcure’s dolutegravir 50 mg tablet prequalified
WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
Incepta’s medroxyprogesterone injection prequalified
WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
Shanghai Harvest Pharmaceutical’s kanamycin injection prequalified
WHO Prequalification Unit (PQT) added the below new products to its prequalified list:
Lupin’s emtricitabine/tenofovir tablet prequalified
WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
WHO publishes Emergency Use Listing procedure and roadmap to make new medical products more readily available during health emergencies
WHO published the Emergency Use Listing (EUL) procedure to streamline the process by which new or unlicensed products can be used during public health emergencies.
7th Invitation to manufacturers of medicinal products for treatment of Neglected Tropical Diseases (NTDs), to submit an Expression of Interest (EOI) for product evaluation to the WHO Prequalification Unit
Products added under:
Singl
Launch of pilot programme for international cooperation in GMP inspections of manufacturers of sterile medicinal products for human use
International collaboration in the inspection of manufacturers of active pharmaceutical ingredients has been beneficial over the last few years (1).
Hetero’s dolutegravir/lamivudine/tenofovir tablet prequalified
WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
First biosimilar product prequalified
WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
Lupin’s lamivudine/tenofovir 300mg/300mg tablet prequalified
WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
Teva’s generic atazanavir prequalified
WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
First co-blister of daclatasvir/sofosbuvir prequalified
WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
Cipla’s 30mg and 60mg daclatasvir tablet prequalified
WHO Prequalification Team - Medicines (PQTm) added the below new products to its prequalified list:
Hetero’s daclatasvir 30mg and 60mg tablet prequalified
WHO Prequalification Team - Medicines (PQTm) added the below new products to its prequalified list:
Roche sulfamethoxazole/trimethoprim prequalified
WHO Prequalification Team - Medicines (PQTm) added the below new products to its prequalified list:
Celltrion’s lamivudine/tenofovir tablet prequalified
WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
Sun’s dolutegravir/lamivudine/tenofovir tablet prequalified
WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
Milan’s sulfamethoxazole/trimethoprim tablet prequalified
WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
Clarifications regarding carton-free supply of prequalified products packaged in bottles
PQTm acknowledges the advantages of carton-free supply of medicinal products that are presented in bottle packs and therefore support initiatives for carton free packaging being promoted by various
Clarifications regarding carton-free supply of prequalified products packaged in bottles
PQTm acknowledges the advantages of carton-free supply of medicinal products that are presented in bottle packs and therefore support initiatives for carton free packaging being promoted by various