MHRA Explains Entry Criteria for UK's New Innovative Medicines Pathway

‘Innovation Passport’ Will Be Gateway To Targeted Development

A new licensing route is to be introduced by the UK MHRA next year for products that meet specific criteria, such as treating life threatening conditions or rare diseases and where there is a significant patient need. At a webinar this week, an MHRA medical assessor looked at the requirements that products will have to meet to enter the new pathway.

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The UK is offering a new licensing pathway for innovative drugs • Source: Shutterstock

The UK regulator, the MHRA, is running a pilot to test out the practicalities of creating “target development profiles” that will guide the development of new medicines under its innovative medicines licensing pathway to be introduced in January next year.

The new integrated pathway will pull together expertise from across the Medicines and Healthcare products Regulatory Agency and from partners in the wider health care system, including NICE and the SMC, the

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