Action Needed To Prevent Post-Brexit Catastrophe In Northern Ireland

BGMA Warns That Market Could Become ‘Unviable’ Without Fresh Approach

Action is needed from both the UK government and the European Commission to prevent a collapse of Northern Ireland’s generics market, according to the BGMA.

Northern Ireland Map
Northern Ireland’s market is suffering from the fallout of Brexit • Source: Alamy

Increasing regulatory burdens and complexity linked to Northern Ireland mean that the region could soon become an unviable market for UK generics suppliers, the British Generic Manufacturers Association has warned.

The association has called for fresh action from both the UK government and European Commission to resolve the complexities resulting from Brexit and the related Northern Ireland Protocol, cautioning that without a longer-term political resolution the market risks

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

More from Regulation

Teva And Alvotech Celebrate Interchangeability For US Ustekinumab

 
• By 

The market for biosimilar rivals to Stelara continues to be hotly contested in the US, with partners Teva and Alvotech claiming a boost from an interchangeability designation at the same time as Biocon Biologics highlighted fresh market access agreements.

Sandoz Slims Down Pembrolizumab Trial As Regulators Streamline Requirements

 
• By 

As Sandoz continues development of its planned pembrolizumab biosimilar rival to Keytruda, the company has revealed plans to slim down its Phase III trial amid the latest moves from regulators towards streamlining clinical study requirements for biosimilar registration.

Rage Against The Machine: Generics CEOs Slam Systemic Problems In The US

 
• By 

During the “CEOs Unplugged” panel at the AAM’s annual conference in February, leaders from Sandoz, Lupin and Amneal discussed the various ways in which the US framework is making life difficult for generics and biosimilars.

US FDA Shows Support For Generic Drug User Fee Goals Amid Cutbacks

 

The FDA struck an upbeat tone during its annual Generic Drugs Forum despite an unprecedented period of cutbacks and disruptions and reiterated a desire to continue meeting user fee goals.

More from Policy & Regulation