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Combined Trial Reviews To Become The Norm In UK From 2022

 
• By Vibha Sharma

Having gained enough experience with the combined ethics and regulatory review of clinical trial applications, the UK will make this its only route for evaluating new drug trial applications starting next year.

Business, Technology, Internet and network concept. Business man working on the tablet of the future, select on the virtual display: Clinical trial
UK Is Streamlining The Way Clinical Trials Are Reviewed • Source: Shutterstock

A UK pilot that allowed sponsors to obtain a joint decision on the ethical and regulatory approval of their clinical trial applications has been completed and will become the only way to apply for all trial evaluations from 1 January 2022.

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Non-Submissions To UK HTA Body Could Increase Unless Commercial Environment Improves, Warns Industry

 
• By Leela Barham

Finding ways to lower the rebates paid by the pharmaceutical industry to the UK government and fostering partnerships to make the UK a more attractive launch market could help reduce the number of terminated technology appraisals conducted by NICE, the health technology appraisal institute, says the UK pharmaceutical industry.

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UK Mandates Unmodified Standardized Contracts To Speed Clinical Trial Set-Up

 
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The policy expectation that the model clinical trial agreements are used without modification is in line requests from industry and the NHS/HSC.

UK MHRA Tackles Staff Burnout As It Eliminates Filings Backlog

 
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Efforts by the medicines regulator, the MHRA, to clear all backlogs relating to its statutory functions and maintaining predictable review timeframes have put pressure on its staff.

More from Europe

Non-Submissions To England’s NICE Surge Across All Disease Areas

 
• By Leela Barham

Blood cancer therapies were most proportionately impacted by the failure of pharmaceutical companies to submit evidence on their cancer therapies to England’s health technology appraisal body, shows analysis by the Pink Sheet.

UK Mandates Unmodified Standardized Contracts To Speed Clinical Trial Set-Up

 
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New EU Filings

 
• By Neena Brizmohun

Plozasiran, Arrowhead Pharmaceuticals' treatment for familial chylomicronemia syndrome, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.