MHRA: Extended use of EC Decision Reliance Procedure across Great Britain
On 30 September 2022 the MHRA informed that the use of the European Commission Decision Reliance Procedure (ECDRP) for Great Britain has been extended for another 12 months until 31 December 2023. The procedure allows a company to submit a product that has received approval from the EMA directly to the MHRA. The MHRA can then grant a license with a shorter review than normally conducted, relying on the EMA’s decision.
The one-year extension should ensure timely access to medicines for the British people while MHRA works on developing an independent and new international reliance framework. It also reduces the risk of companies deprioritizing Great Britain for medicines authorization. The continuation of the ECDRP also includes variations and extensions.
Regarding future paths, the MHRA already takes part in Project Orbis, which is coordinated by the US FDA. The programme provides a framework for concurrent submission and review of oncology products among international partners. It aims to deliver faster patient access to innovative cancer treatments with potential benefits over existing therapies. Alongside the MHRA, it involves the regulatory authorities of Australis, Canada, Singapore, Switzerland, and Brazil.
Source:
MHRA: EC DRP extension
MHRA: Project Orbis
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