MHRA announces new international recognition framework for MAs from 2024 9 Feb 2023
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has confirmed that the European Commission Decision Reliance Procedure (ECDRP) has been extended to 31 December 2023. After that a new international recognition framework will be instituted, from 1 January 2024.
Companies receiving a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) can continue to submit ECDRP Marketing Authorisation Applications (MAAs) to MHRA until the end of the year. From 2024, applications will be made through the MHRA’s new international recognition framework, which will take account of decisions already made by the European Medicines Agency and other regulators.