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
An appendix has been added to the Bioequivalence Trial Information Form (BTIF).
Updated versions of the Bioequivalence Trial Information Form (BTIF) and the Application for a biowaiver: Biopharmaceutics Classification System (BCS) fo
WHO Prequalification Team - Medicines (PQTm) added the below new products to its prequalified list:
WHO Prequalification Team - Medicines (PQTm) added the below new products to its prequalified list:
WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
Tenofovir disoproxil fumarate (
New addition to the List of Prequalified Quality Control Laboratories (QCLs):
The development of paediatric formulations for essential medicines has been recognized as a critical step for successful healthcare delivery.
WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
Praziquantel (WHOAPI-309) manufactured by Shanghai Desano Chemical Pharmaceutical Co Ltd has been prequalified by the WHO Prequalification Team: medicines under its AP
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
Linezolid (WHOAPI-252) and Kanamycin (acid
WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
WHO Prequalification Team - Medicines (PQTm) added the below new products to its prequalified list:
WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
On 18 May 2018, WHO has issued a web statement signalling a potential risk of neural tube defects in infants born to women who were taking dolutegravir (DTG) at the time of conception.
The ICHQ3D guideline presents a process to assess and control elemental impurities in drug products using the principles of risk assessment.
In April 2018, EMA published a report with an overview of the activities of the programme between 2011 and 2016.
WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list: