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

UK MHRA Says Time For ‘Tough Decisions’ On Entry To Innovative Pathway

 
• By Vibha Sharma

The UK regulator wants to revise the broad definition it applies to drugs entering its Innovative Licensing and Access Pathway so that the scheme resembles similar offerings by other regulators, such as the EMA’s PRIME and the US FDA’s Breakthrough Therapy Designation.

Desperate office worker overwhelmed with paperwork, she is asking help with her hand
Too Many Drugs Being Assigned To The ILAP Are Overwhelming Regulator Capacity • Source: Shutterstock

The UK medicines regulator is planning to raise the bar for drug companies wanting to enter its Innovative Licensing and Access Pathway (ILAP), which is designed to accelerate the development and approval times of new innovative products and indications, and facilitate patient access. 

Key Takeaways

  • The UK Medicines and Healthcare products Regulatory Agency is working on the next phase of its Innovative Licensing and Access Pathway (ILAP), which which will include a revised eligibility criteria.

  • ILAP is UK’s flagship initiative that connects the medicines regulator with health technology assessment bodies, creating a pathway that aims to deliver safe, effective, financially sustainable, and early patient access to innovative medicines.

  • The MHRA’s current definition of innovation is too broad and it wants to ensure that the revised ILAP focuses on products that are truly transformative and address unmet needs.

  • A recent review found that “too many products” were being assigned to the ILAP, “overwhelming regulator capacity and leading to slow processing of applications

The Medicines and Healthcare products Regulatory Agency wants to narrow the ILAP’s entry criteria to ensure that it focuses on products that are truly transformative and address areas of unmet

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

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.

UK MHRA Tackles Staff Burnout As It Eliminates Filings Backlog

 
• By Vibha Sharma

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

Raising Drug Prices In The EU Could Take Years, Even If Pharma Effort Succeeds

 
• By Cathy Kelly

Manufacturers are engaging the European Commission and individual countries to allocate more health care spending to innovative medicines and align prices more closely to those in the US.

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.