News
Newly prequalified Active Pharmaceutical Ingredient (API)
Ethionamide (WHOAPI-422) manufactured by Micro Labs Limited, has
New Invitation for Expression of Interest (EOI) for Active Pharmaceutical Ingredients (APIs) published
The following API was added:
Newly prequalified Active Pharmaceutical Ingredient (API)
Oseltamivir (phosphate) (WHOAPI-421) manufactured by Shanghai Desano Chemical Pharmaceu
1st Invitation to manufacturers of medicinal products for treatment of multi-drug resistant bacterial infections, to submit an Expression of Interest (EOI) for product evaluation to the WHO Prequalification Unit
A 1st Invitation for Expression of Interest (EOI) for treatment of multi-drug resistant bacterial infections has been published by the WHO Prequalification Unit - Medicines Assessment Team (PQT/MED
Two PQT Medicines trainings for regulators in 2023
The 15th Annual Prequalification Team: Medicines (PQT/MED) Quality Assessment Training will be a virtual workshop that will take place on Monday, 5 June through Thursday, 8 June 2023.
Bial’s misoprostol vaginal tablet prequalified
WHO Prequalification Unit (PQT) added the below new products to its prequalified list:
WHO Collaborative Registration Procedure – Update for IVD Manufacturers
The PQ IVD Assessment Team held a virtual Workshop on the 15th of March with in vitro diagnostic (IVD) manufacturers to provide an update on implementation of the Collaborative Registration Procedu
First benzyl penicillins prequalified. For treatment of maternal syphilis and prevention of congenital syphilis.
WHO Prequalification Unit (PQT) added the below new products to its prequalified list:
Cipla’s abacavir/lamivudine prequalified
WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
Request for Proposals (RFP) - Post Market Monitoring Country Technical Support to WHO Immunization and Equipment Prequalification Team
The purpose of this Request for Proposals (RFP) is to enter into a contractual agreement with a successful bidder and select a suitable contractor to support up to 5 countries to implement Post Mar
Request for Proposals (RFP) - Solar Direct Drive Walk-in Cold & Freezer Rooms Field Evaluation
The purpose of this Request for Proposals (RFP) is to enter into a contractual agreement with a successful bidder and select a suitable Contractor to carry out the following work: to implement a tw
Request for Proposals (RFP) - Technical Assistance to WHO Immunization and Equipment Prequalification Team
The purpose of this Request for Proposals (RFP) is to enter into a contractual agreement with a successful bidder and select a suitable Contractor to carry out the following work: Vaccines & Im
New Invitation for Expression of Interest (EOI) for Active Pharmaceutical Ingredients (APIs) published
The following API was added:
- APIs for antimalarial medicinal products
- Quinine (hydrochloride)
WHO IVD PQ and EUL Ukraine Workshop
In partnership with the European Regional Office and WHO Country Office in Ukraine the PQ IVD Assessment Team held a virtual Workshop on the 10th of February with regulators from the National Regul
New Invitation for Expression of Interest (EOI) to manufacturers of Antimalarial Medicines Published
New Invitation for Expression of Interest (EOI) to manufacturers of Antimalarial Medicines.
Janssen’s darunavir prequalified
WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
EPQs email account notification
As of 2023 the WHO Prequalification Team has started using the ePQS platform (Salesforce cloud-based software) to manage application submissions and workflow.
Special announcement to manufacturers regarding Malaria RDTs
We have been receiving applications from several manufacturers of malaria RDTs, either as new product applications or as Change Requests, regarding the inclusion single-test configurations in their
ICH Harmonised Guideline M10 Bioanalytical Method Validation and Study Sample Analysis to be implemented by PQT/MED
The recent ICH Harmonised Guideline M10 Bioanalytical Method Validation and Study Sample Analysis, adopted by ICH 24 May 2022, will be implemented by PQT/MED effective 1 May 2023