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UK Vaunts 'New Era' In Drug Approvals

Several New Routes To Market Are Now Available To Applicants

 
• By Ian Schofield

The UK regulator, the MHRA, has published guidance on its new integrated pathway for innovative drug approvals, which it says is intended to bring together partners including health technology assessment agencies, health care bodies and patient organizations to offer “sustained collaboration” with drug developers.

Doubtful person, hands on hips, choosing the way as multiple arrows on the road showing a mess of different directions. Choosing the correct pathway, difficult decision concept, confusion symbol.
The UK has launched its new innovative medicines pathway • Source: Shutterstock

The UK’s Medicines and Healthcare products Regulatory Agency has launched its new licensing and access pathway for innovative medicines that the agency says will prepare it for “a new era in medicines approvals in the UK.”

The Innovative Licensing and Access Pathway (ILAP), which was announced last year, is intended to reduce the time taken to get innovative drugs to market. It features a new medicines designation, the “innovation passport,” that will act as the gateway to the creation of a product-specific roadmap to guide drug development

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England: HTA Sandbox Helping To Assess ‘Challenging’ Drugs & Indications

 
• By Eliza Slawther

England’s health technology assessment institute explains how its sandbox environment is helping to test new evaluation methods for drugs or indications with which it does not have experience, such as metabolic dysfunction-associated steatohepatitis.

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.

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

 
• By Vibha Sharma

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

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