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.
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.
WHO Prequalification Unit (PQT) added the below new products to its prequalified list:
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
WHO Prequalification Unit (PQT) added the below new products to its prequalified list:
WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
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
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
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
The following API was added:
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.
WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
As of 2023 the WHO Prequalification Team has started using the ePQS platform (Salesforce cloud-based software) to manage application submissions and workflow.
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
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
Flucytosine (WHOAPI-406) manufactured by Solara Active Pharma Sciences Limited, has been prequalified by the