1. Generics Bulletin
  2. >>Policy & Regulation
  3. >>Regulation

UK Body Urges Action On Licensing Delays As MHRA Unveils Guidance For Established Products

Regulator Aims To Shorten Timeframes For Assessment Of Established Medicines

 
• By Dave Wallace

UK MHRA guidance outlining process changes aimed at shortening timeframes for assessing established medicines has been welcomed by the BGMA, which has emphasized the need to clear the regulator’s current approvals backlog that the association says is exacerbating shortages.

Clock moving fast with blur, high speed concept
Speedier approvals are needed to clear the MHRA backlog • Source: Shutterstock

Guidance has been unveiled by the UK Medicines and Healthcare products Regulatory Agency outlining process changes for assessing established medicines that are aimed at shortening timeframes for assessment.

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Generics Bulletin 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 Regulation

Cardinal Looks Ahead To A New Decade For US Biosimilars

 
• By Dave Wallace

In the wake of a report marking 10 years since the first US biosimilar launch, Cardinal Health’s Dracey Poore speaks to Generics Bulletin about the successes seen so far and the obstacles that must be overcome if the market is to thrive in the decade ahead.

Regulatory Recap: UK To Capture £1bn Savings With Framework For Best-Value Biologics

 
• By Urtė Fultinavičiūtė

Generics Bulletin reviews global regulatory developments across the world.

US Bill Recap: Senate Judiciary Committee Offers Fresh Start For Reintroduced Off-Patent Drug Bills

 
• By Urtė Fultinavičiūtė

The US Senate Judiciary Committee’s Chairman Chuck Grassley criticized the Senate’s reduced working hours as six previously introduced bills once again land on their desk.

Henlius And Outlook Move Forward With Ophthalmic Bevacizumab

 
• By Dave Wallace

Henlius has reported progress in its development of a bevacizumab product for treating ophthalmic diseases, with its Essex-partnered HLX04-O candidate meeting its primary endpoint in a Phase III trial. Meanwhile, Outlook Therapeutics has taken another shot at getting its own ophthalmic bevacizumab approved in the US after resubmitting its filing.

More from Policy & Regulation

Missing BsUFA Revenue Trigger Could Open US FDA Staff To Criminal Penalty

 
• By Derrick Gingery

Massive layoffs and the biosimilar user fee program’s historic flirtation with the non-user fee spending requirements raise concerns that the FDA could lose its ability to collect BsUFA revenue, which could mean a fine or jail time for agency staff.

Henlius And Outlook Move Forward With Ophthalmic Bevacizumab

 
• By Dave Wallace

Henlius has reported progress in its development of a bevacizumab product for treating ophthalmic diseases, with its Essex-partnered HLX04-O candidate meeting its primary endpoint in a Phase III trial. Meanwhile, Outlook Therapeutics has taken another shot at getting its own ophthalmic bevacizumab approved in the US after resubmitting its filing.

Pulling Together: Global Regulators Discuss Convergence On Biosimilars

 
• By Dave Wallace

While the biosimilars industry has welcomed individual pockets of progress around regulatory streamlining, it is essential that approaches from global authorities move forward together if they are to have a meaningful impact on biosimilar development. At Medicines for Europe’s annual biosimilars conference, regulators from around the world talked about how their thinking is converging.