European Commission procedure extended, says MHRA
The European Commission Decision Reliance Procedure (ECDRP) has been extended to December 31, 2023, when a new international recognition framework will be in place, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) announced today.
Before December 31, 2023, where a European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) positive opinion has been received, applicants can continue to submit their ECDRP Marketing Authorization Application (MAA) or variations to the MHRA, which will continue to review these applications via the current ECDRP process.
From January 1, 2024, applicants can apply to MHRA through its new international recognition framework, which will have regard to decisions already made by the EMA and certain other regulators. This means applications with a CHMP positive opinion received after December 31, 2023 will be eligible.
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