ABPI response to MHRA European Commission Decision Reliance Procedure (ECDRP) announcement

The MHRA has announced that European Medicines Agency (EMA) applications which receive a Committee for Medicinal Products for Human Use (CHMP) positive opinion before the end of 31 December 2023, are eligible to be submitted for MHRA approval via the current European Commission Decision Reliance Procedure (ECDRP) route. 

On 1 January 2024, MHRA will launch a new streamlined international recognition framework which will have regard to decisions already made by the EMA and certain other regulators, to be announced. This means applications with a CHMP positive opinion received after 31 December 2023 will be eligible.

Responding to the decision, David Watson, Executive Director, Patient Access said:

“The MHRA’s pragmatic decision regarding GB marketing authorisation applications is an important one for our industry. Pharmaceutical companies now have the clarity needed to inform their regulatory decisions for the year.

“We look forward to working with the MHRA on the development of their new international recognition framework that will come into force from 2024 onwards.”

Background

The European Commission Decision Reliance Procedure (ECDRP) was introduced post-Brexit and allows the MHRA to “rely” on a European decision to grant a new marketing authorisation for a product.

If a medicine receives a positive recommendation from the European Medicines Agency, the MHRA can complete a lighter touch assessment.

This assessment can then be fast tracked, reducing the time delay for regulatory approval between both sides.

The MHRA has previously acknowledged the risk of companies deprioritising Great Britain as a market without this procedure.

It was extended by 12 months until the end of 2023 to allow MHRA to develop a new international framework and to minimise burden on companies.