UK Regulator On Using The New International Reliance Procedure To Encourage Filings

The MHRA says that further guidance is coming on the dossier requirements and fee levels for the new recognition procedure, and that electronic forms for determining the eligibility of submissions for the procedure will be published shortly.

rules and regulations marked on rubber stamp
The UK MHRA is to have a new reliance route for drug approvals • Source: Shutterstock

The UK’s new International Recognition Procedure is intended to “enhance the attractiveness of the UK” by creating an environment where the pharmaceutical sector is able to develop and launch new medicines more quickly for the benefit of public health, according to Julian Beach of the Medicines and Healthcare products Regulatory Agency (MHRA).

At the beginning of 2024, the IRP will replace the European Commission Decision Reliance Procedure (ECDRP), which allows the MHRA to rely on EU approval decisions when considering applications for GB

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