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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...

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What UK’s Clinical Trials Overhaul Means For Orphan Drug Developers

 
• By Eliza Slawther

The UK government has acknowledged that sponsors of clinical trials for rare diseases face challenges around patient recruitment and trial design, which will be addressed in its clinical trials reform, a lawyer says.

‘Brainless’ US MFN Policy Could Drive Pharma Investment To Europe

 
• By Francesca Bruce

European health systems already pay far too much for new medicines and payers will not accept higher prices to compensate for lower US prices, according to Anja Schiel, from NOMA, the Norwegian health technology assessment body.

Orphan Drug Trial Sponsors ‘Playing Catch-Up’ With Regulators – But Automation Can Help

 
• By Eliza Slawther

Clinical trial sponsors in the rare disease space face “big safety demands” from regulators, which can be challenging for those with limited resources. A CRO founder makes the case for “embedding automation” into the clinical trial process to keep pace with regulatory requirements.