Industry Heralds Progress On Northern Ireland

BGMA Says Commission Proposals ‘Go A Long Way To Addressing Concerns’

Fresh proposals from the European Commission on how to regulate the supply of medicines in Northern Ireland offer cause for optimism, the BGMA believes, with the move going “a long way to addressing the significant concerns we had about supply to the region.”

World Map UK Northern Ireland
The latest EU proposals represent progress for Northern Ireland • Source: boldg / Alamy Stock Vector

Fresh proposals from the European Commission over the regulation of medicines supplied in Northern Ireland have received an optimistic welcome from the British Generic Manufacturers Association, as well as brand industry bodies the Association of the British Pharmaceutical Industry and European Federation of Pharmaceutical Industries and Associations.

More from Regulation

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.

OGD’s Policy Office Cut To Have ‘Profound’ Impact On New Generic Approvals, Warns Former FDA Head Gottlieb

 

The elimination of the policy division at the Office of Generic Drugs, tariffs, the Section 232 investigation, and a new executive order to promote lower drug prices seem to both cause and purport to solve the same problem: supply chain disruption.

Cardinal Looks Ahead To A New Decade For US Biosimilars

 
• By 

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.

More from Policy & Regulation

Cardinal Looks Ahead To A New Decade For US Biosimilars

 
• By 

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

 

Generics Bulletin reviews global regulatory developments across the world.

As US Launches Pharma Probe, AAM Warns Tariffs ‘Will Only Amplify Problems’

 
• By 

News of a fresh US investigation into the pharma sector has sparked renewed concerns over the impact that US trade tariffs would have on the generics and biosimilars industry. The AAM has responded with a warning over the potential effects on shortages and access, while Medicines for Europe has proposed five key action areas to bolster the sector in Europe.