How To Get Orphan Drug Status In Great Britain From 2021

Post-Brexit Rules Broadly In Line With EU

Updated guidance from the UK regulator, the MHRA, outlines the rules on orphan drug applications, criteria and exclusivity periods that will apply in Great Britain after the end of the Brexit transition period.

Brexit_Pills
The UK MHRA has issued guidance on orphan designation in Great Britain • Source: Shutterstock

From the beginning of 2021, companies wanting an orphan drug designation in Great Britain will need to apply for it at the same time as they file the marketing authorization application (MAA), using a new application form. There will be "no pre-marketing authorization orphan designation” for Great Britain, says new guidance on post-Brexit medicines regulation.

Incentives for orphan drug development will be provided in the form of market exclusivity and “full or partial refunds for...

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

More from United Kingdom

UK MHRA: Bacteriophage Developers Wanted ‘More Clarity’ On UK Framework

 

Julian Beach, interim executive director of healthcare quality and access at the UK drug regulator, the MHRA, tells the Pink Sheet how the agency is responding to increased efforts to develop bacteriophage therapies.

Respiratory Treatments Hit Hardest By HTA Terminations In England

 
• By 

Exclusive analysis by the Pink Sheet explores how non-submissions by pharmaceutical companies to England’s health technology appraisal body are impacting the availability of medicines on the National Health Service.

MHRA Backs Bacteriophage Innovation To Fight Antimicrobial Resistance

 

The UK regulator wants to help companies to develop bacteriophages for the treatment of infections. Its first guidance on this topic offers advice to researchers and sets out the regulatory requirements they will need to meet.

Scientists Work With AI To Uncover ‘Unexpected’ Drug Combos For Breast Cancer

 

A UK research team has used artificial intelligence to find new treatments for cancer using existing US Food and Drug Administration-approved medicines that are not normally not used for the disease.

More from Europe

EU Pharma Reform Package Clears Big Political Hurdle After Council Adopts Position

 

The Council of the EU has made several key amendments to the legislative reform package, which it will now negotiate with the European Parliament.

MHRA Backs Bacteriophage Innovation To Fight Antimicrobial Resistance

 

The UK regulator wants to help companies to develop bacteriophages for the treatment of infections. Its first guidance on this topic offers advice to researchers and sets out the regulatory requirements they will need to meet.

Scientists Work With AI To Uncover ‘Unexpected’ Drug Combos For Breast Cancer

 

A UK research team has used artificial intelligence to find new treatments for cancer using existing US Food and Drug Administration-approved medicines that are not normally not used for the disease.