The UK’s regulatory agency MHRA has announced the possibility to continue submissions for MHRA approval via the current European Commission Decision Reliance Procedure (ECDRP) route for EMA’s applications which will receive a CHMP positive opinion before 31 December 2023. A new streamlined international recognition framework is expected to be launched by the MHRA on 1 January 2024. The new framework should refer to decisions already made by the EMA, as well as other international regulators to be announced by UK’s authorities. Products receiving a CHMP positive opinion after 31 December 2023 will be eligible to enter the new framework. Applications through the decentralised and mutual recognition reliance procedure (MRDCRP) will still be possible after 31 December 2023.
MHRA’s initiative aims to increase routes available to companies to market medicinal products in the UK. A detailed guidance about the new framework has been announced to be published, including any transition arrangements for applications received under existing frameworks. The ECDRP was introduced post-Brexit to facilitate the granting of marketing authorisations in Great Britain on the basis of a European similar decision. In such instances, the assessment of the dossier by the MHRA may be lighter and faster, thus reducing the risk of companies deprioritising Great Britain as a market.