We set out in a previous post that the UK Medicines and Healthcare products Regulatory Agency (MHRA) intends to introduce a new international recognition procedure (IRP) for medicinal products, whereby decisions taken in certain countries could be recognised by the MHRA to fast-track approval in the UK.

On 30 August 2023, the MHRA published detailed guidance on how it will use the IRP for medicinal products. The IRP will be open to applicants who have already received an authorisation for the same product from one of the MHRA’s specified Reference Regulators (RRs) in Australia, Canada, the European Union, Japan, Switzerland, Singapore and the United States. However, the MHRA retains the right to reject the IRP and conduct a full assessment if considered necessary.

This procedure will operate in parallel to the MHRA’s current national procedures, including the shortened 150-day timetable, offering applicants a range of authorisation routes depending on the status in other countries and type of application. The hope is that this will allow the MHRA to be able to use the decisions in other countries, while still being able to conduct its own assessment where necessary for the UK market.

The IRP will be available from 1 January 2024. However, until the Windsor framework is in place on 1 January 2025, discussed here, products falling within the scope of the EU Centralised Procedure can only be authorised in Great Britain (England, Scotland and Wales).Continue Reading New UK International Recognition Framework for Medicines