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UK Explains New ‘Reliance’ Routes To Approval Based On EU Dossiers

Firms Urged To File Early To Secure Timely Decisions

 
• By Ian Schofield

Companies seeking marketing authorizations in the UK or Great Britain will be able to make use of two new “reliance” procedures offering regulatory assessment times of 67 days or less if their products have already gone through the EU centralized or decentralized approval systems.

train fast run on railway track in sunny day
New UK processes will allow speedier drug assessments • Source: Shutterstock

The UK regulator, the MHRA, has published details of the abbreviated process it will use to assess Great Britain marketing authorization applications (MAAs) for products that have received a positive opinion from the European Medicines Agency’s drug evaluation committee, the CHMP, under the EU’s centralized assessment procedure.

The “European Commission Decision Reliance Procedure” (ECDRP), which offers the possibility of GB approval within 67 days of the application being validated by the MHRA, includes an incentive for companies to file as soon as possible after the

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