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NICE Reform Plans Aim To Help Make Post-Brexit UK A ‘First-Launch’ Country

HTA Body's Methodology Review Includes Accepting More Uncertainty

 
• By Ian Schofield

Following a Brexit-induced delay over the summer, England's HTA body NICE has come up with a concrete set of proposals that it says will help it “robustly and efficiently” evaluate innovative technologies such as advanced therapies, histology-independent cancer treatments, and technologies for rare diseases. Industry bodies have welcomed the plans, which have just been put out for consultation.

Finger about to press a start button with the word innovation on the left. Composite between an image and a 3D background
NICE wants to ensure its ability to evaluate innovative technologies • Source: Shutterstock

NICE, the health technology assessment body for England, has launched its long-awaited consultation on changes to the methods it uses to assess new technologies such as medicines, medical products and diagnostics in a bid to ensure the methods “remain cutting edge and future proof.” 

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HRA To Revisit Simplified Consent Provisions Under New UK Clinical Trials Law

 
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UK Promises To ‘Turbocharge’ Clinical Trials As US Tariff Threat Remains

 
• By Andrew McConaghie

Faced with Trump’s hostile tariff moves, the UK aims to speed up clinical trial start times to support its pharma sector and invest £600m in a new health data research service.

More from Europe

EU Pharmacopoeia Adopts ‘Groundbreaking’ Cell Therapy Chapter, Seeks Feedback On Alternative Microbiological Tests

 
• By Neena Brizmohun

A new chapter that will be published in the European Pharmacopoeia soon is expected to provide a comprehensive framework for the production and quality control of cell-based preparations. Meanwhile, an existing chapter has been revised to facilitate the implementation of rapid microbiological testing methods.

New EU Approvals

 
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The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include four new products, one of which is Tivdak, Pfizer/Genmab’s treatment for previously treated recurrent or metastatic cervical cancer.

Industry Keen On ‘Stepwise’ PIPs, But Future Hinges On EU Pharma Legislation Reform

 
• By Eliza Slawther

Industry feedback on a European Medicines Agency pilot that introduced a “stepwise” approach to pediatric investigation plans was positive, but the future of the new model will depend on the outcome of the pharmaceutical legislation negotiations, the agency says.