Before 31 December 2023, where a Committee for Medicinal Products for Human Use (CHMP) positive opinion has been received, you can continue to submit your ECDRP Marketing Authorisation Application (MAA) or variations to MHRA. MHRA will continue to review these applications via the current ECDRP process.
From 1 January 2024 you can apply to MHRA through our new international recognition framework, which will have regard to decisions already made by the European Medicines Agency and certain other regulators. This means applications with a CHMP positive opinion received after 31 December 2023 will be eligible.
Our aim is to extend the countries whose assessments we will take account of, increasing routes to market in the UK. We will communicate who these additional regulators are and publish detailed guidance about this new framework in due course, including any transition arrangements for applications received under existing frameworks. We continue to collaborate closely with Trade Associations in the development of these arrangements and guidance.