The new framework will support patients in the UK with expedited access to safe and effective medicines that have been approved by trusted regulatory partners.
The MHRA has announced that, from 1 January 2024, the EC Decision Reliance Procedure (ECDRP) will be replaced by the new International Recognition Procedure (IRP), which will sit alongside the MHRA’s current national procedures. The Mutual Recognition/Decentralised Reliance Procedure (MRDCRP) will be incorporated under the umbrella of the IRP. The IRP will allow the MHRA to make use of the expertise and decision making of its regulatory partners for the benefit of UK patients.
The MHRA will conduct a targeted assessment of IRP applications but will retain the authority to reject them if the evidence provided is considered insufficiently robust.
The MHRA notes that
• any ECDRP and MRDCRP submissions received before 1 January 2024 will be processed under the existing practices
• the IRP will be open to applicants that have already received an authorisation for the same product from one of the MHRA’s specified reference regulators
• until the Windsor Framework is implemented in Northern Ireland on 1 January 2025, products falling within the scope of the EU centralised procedure can only be authorised in Great Britain.