The MHRA lifted some extra burden from the industry by extending the European Commission Decision Reliance Procedure (ECDRP) by 12 months until 31 December 2023. The ECDRP was introduced following Brexit and is available to medicines approved via the EU centralized procedure.
Before 31 December 2023, in situations where a Committee for Medicinal Products for Human Use (CHMP) positive opinion has been received, applicants can continue to submit their ECDRP Marketing Authorisation Application (MAA) or variations to MHRA, and MHRA will continue to review these applications via the current ECDRP process.
The MHRA also announced that from 1 January 2024, a new international recognition framework will be in place, which will have regard to decisions already made by the European Medicines Agency/European Commission and certain other regulators.
MHRA, in its announcement, said that “Our aim is to extend the countries whose assessments we will take account of, increasing routes to market in the UK.”
The Association of British Pharmaceutical Industry (ABPI) responded positively to the MHRAs announcement noting that it minimizes the burden on companies and that it will allow MHRA to develop a new international framework.
For further information, please talk to Elina Angeloudi, Jaspreet Takhar or Julia Gillert from our London office