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UK Unveils Go-It-Alone Drug Approval System

Accelerated Reviews Part Of MHRA's Post-Brexit Plans

 
• By Ian Schofield

Special approval procedures for new drugs and biosimilars, more use of real-world data, a streamlined drug safety monitoring system, and a ‘patient-first culture.’ The MHRA has plenty of ideas in store for its post-Brexit life as a fully independent regulator from January next year.

Conceptual hand writing showing New Regulations. Business photo showcasing rules made government order control something done.
The MHRA will have freestanding medicine regulations from next year • Source: Shutterstock

The UK regulator, the MHRA, is to introduce a new accelerated licensing procedure for innovative medicines from the beginning of 2021, when it is due to assume full responsibility for marketing authorizations and related regulatory activities as a result of the country's departure from the EU.

The agency will have a closer focus on patient access to highly innovative products, and more use will be made of real-world data to support both clinical trials and drug...

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