Past News
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
First liposomal amphotericin B powder for injection prequalified
WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
Second rectal artesunate capsule prequalified
WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
Ipca's paediatric artemether/lumefantrine tablet prequalified
WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
Labesfal's Mg injection prequalified
WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
Hisun's kanamycin injection prequalified
WHO Prequalification Team - Medicines (PQTm) added the below new products to its prequalified list:
MSN's moxifloxacin tablet prequalified
WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
ViiV Healthcare's abacavir/lamivudine tablet prequalified
WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
Hetero's paediatric lopinavir/ritonavir tablet prequalified
WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
Questions and answers on DTG use in women of childbearing age
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.
ICHQ3D introduced for APIMF and API prequalification procedures
The ICHQ3D guideline presents a process to assess and control elemental impurities in drug products using the principles of risk assessment.
Report on the international API inspection programme 2011 - 2016
In April 2018, EMA published a report with an overview of the activities of the programme between 2011 and 2016.
First amikacin injection prequalified
WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
Newly prequalified Quality Control Laboratory (QCL)
New addition to the List of Prequalified Quality Control
HLL’s levonorgestrel prequalified
WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
Newly prequalified Quality Control Laboratory (QCL)
New addition to the List of Prequalified Quality Control Laboratories (QCLs):
First flucytosine prequalified
WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
First dispersible paediatric ethambutol prequalified
WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list: