Since the United Kingdom’s exit from the European Union in 2020, there have been numerous changes in the procedures implemented to ensure that there is access to medicines for UK patients. One area of interest and a growing topic of discussion in the pharmaceutical industry is the International Recognition Procedure (IRP) which was introduced by the Medicines and Healthcare products Regulatory Agency (MHRA) on 1 January 2024, replacing and expanding on the EC Decision Reliance Procedure (ECDRP). 

The introduction of the IRP has brought opportunities for faster market access for manufacturers by enabling the MHRA to conduct more targeted assessments by taking into account the expertise and decision-making of trusted regulatory partners.