MHRA issues guidance on International Recognition Procedure

Article summary

The Medicines and Healthcare products Regulatory Agency (MHRA) has published guidance on the International Recognition Procedure (IRP), a new international recognition route for medicines using pre-existing approvals from Australia, Canada, the European Union, Japan, Switzerland, Singapore and the United States. The IPR will enable the MHRA to leverage the expertise and decisions of trusted regulatory partners, benefiting UK patients, and will be accessible to applicants who have previously received authorisation for the same product from specified Reference Regulators recognised by the MHRA. From 1 January 2024, the IRP will replace the EC Decision Reliance Procedure (ECDRP), which will also encompass the Mutual Recognition/Decentralised Reliance Procedure (MRDCRP). Submissions for ECDRP and MRDCRP received before this date will follow existing protocols, while a positive opinion from the Committee for Medicinal Products for Human Use should be received, for ECDRP applications, before 31 December 2023. The guidance also includes information on how to apply for the IRP, national...