1. Pink Sheet
  3. >>Europe
  4. >>United Kingdom

UK Presents New Licensing Pathway For Innovative Drugs

MHRA To Be ‘Enabling Regulator’

 
• By Ian Schofield

A “powerful new vision” for the post-Brexit UK regulatory framework was unveiled at a conference organized by the BioIndustry Association and the medicines regulator, the MHRA.

Hands_Sun_Puzzle_Pieces
The MHRA is putting together an integrated regulatory system • Source: Shutterstock

On 1 January 2021 the UK regulator, the MHRA, will launch a new licensing pathway for innovative drugs that will include an “innovative medicine designation” and a new “target development profile” for each product to act as a roadmap for its development.

The new pathway, which envisages “supervised early use” of new products through “adaptive authorization,” is part of a new, integrated UK regulatory framework intended to ensure rapid access to novel medicines when

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from United Kingdom

Industry On Making England’s HTA Innovation Lab A Success

 
• By Eliza Slawther

England’s health technology assessment institute, NICE, must ensure that there is clarity for manufacturers on how its methods and processes might change following testing in its sandbox environment, the Association of the British Pharmaceutical Industry said.

UK Health Data Research Service Looks ‘Encouraging’ For Industry, But Implementation Details Will Be Key

 
• By Anabel Costa-Ferreira

Marcus Vass and Vladimir Murovec of international law firm Osborne Clarke tell the Pink Sheet what the government's planned HDRS might mean for industry, and how it compares with the European Health Data Space.

England: HTA Sandbox Helping To Assess ‘Challenging’ Drugs And 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.

More from Europe

UK Health Data Research Service Looks ‘Encouraging’ For Industry, But Implementation Details Will Be Key

 
• By Anabel Costa-Ferreira

Marcus Vass and Vladimir Murovec of international law firm Osborne Clarke tell the Pink Sheet what the government's planned HDRS might mean for industry, and how it compares with the European Health Data Space.

EU Health Data Space May Speed Up R&D Through Access To Multi-Omics & Clinical Record Data

 
• By Eliza Slawther

The European Health Data Space framework will allow companies to accelerate R&D processes and identify new molecular targets faster by facilitating centralized access to certain types of high-quality data, Finland’s Orion Pharma says.

EU Wants Industry To Define ‘Trade Secrets’ Under Health Data Sharing Regulation

 
• By Eliza Slawther

The European Health Data Space Regulation is deliberately “vague” when it comes to defining trade secrets because the EU wants the pharma industry to make recommendations on safeguarding intellectual property, a policy officer for the European Commission says.