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

 
• By Vibha Sharma
  
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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.

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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.

The Medicines and Healthcare products Regulatory Agency wants to narrow the ILAP’s entry criteria to ensure that it focuses on...

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