Questions raised over UK's International Recognition Procedure

12 September 2023

With the European Commission Decision Reliance Procedure (ECDRP) due to come to an end on December 31, 2023 - subject to consultation - the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) will launch a new International Recognition Procedure (IRP) from January 1, 2024.

The UK has relied on the ECDRP since leaving the European Union in 2021, and the IRP is a replacement of this, seeking to maintain a globally competitive approval system that is both proportionate and committed to ensuring patient safety, while also being attractive to inward investment and industry research and development.

The MHRA recently published more details on the IRP. This new licensing route for medicines - pre and post authorization procedures - allows the MHRA to conduct targeted assessments by recognizing approvals from trusted partner agencies.

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