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How To Use The UK’s New International Recognition Pathway For Drug Approvals

 
• By Neena Brizmohun

Eligibility criteria, how to apply, 60-day and 110-day timetables, major objections and clock stops. These are among the topics that the Medicines and Healthcare products Regulatory Agency covers in newly published guidance for drug companies planning to use the soon to be launched IRP.

The MHRA's IRP will leverage the decision-making of trusted regulatory partners • Source: Shutterstock

The UK Medicines and Healthcare products Regulatory Agency has published detailed guidance on what its planned international recognition procedure (IRP) will require of companies who wish to use the route to submit their drug marketing applications when it is launched next year.

The agency is also seeking feedback to help shape the approach it will use to end the European Commission Decision Reliance Procedure (ECDRP) that it introduced in January 2021 as...

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