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EU Pharma Reform & Reducing Reliance On Asian Imports: What To Expect in 2025

 
• By Neena Brizmohun

The European Commission's 100-day countdown to deliver a Critical Medicines Act, aimed at improving the EU's resilience to supply chain disruptions and price volatility, began last December. Meanwhile, negotiations over the proposed package that will reform the over 20-year-old EU pharmaceutical legislation are now in the hands of the Council of the EU. The Pink Sheet examines what to expect for these key pieces of legislation this year.

Brussels Belgium
Key pharma proposals are expected to be discussed by the Council of the EU this year (Shutterstock)

Will the EU’s new health and animal welfare commissioner deliver on his commitment of publishing a proposal for a Critical Medicines Act within 100 days of the new European Commission taking office in December 2024?

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More from Europe

Vertex’s Alyftrek For CF Among Six Orphans On Track For Pan-EU Approval

 
• By Eliza Slawther

The European Medicines Agency has recommended 16 drugs for EU-wide approval, including Vertex’s cystic fibrosis drug Alyftrek and five other orphans.

EMA’s Role In Regulatory Reliance For Post-Approval Changes

 
• By Vibha Sharma

The European Medicines Agency’s assessments of applications for variations play a key role in supporting international regulatory reliance mechanisms. Companies can aid this by ensuring the scope of their post-approval changes is clear, and notifying the EMA when sharing reports with non-EU regulators.

Semaglutide For MASH Among Raft Of New EU Filings

 
• By Neena Brizmohun

Novo Nordisk’s application seeking EU marketing approval to use its GLP-1 receptor agonist to treat cirrhotic metabolic dysfunction-associated steatohepatitis is one of 15 new drug filings the European Medicines Agency has started reviewing. Meanwhile, Arrowhead’s filing for its familial chylomicronemia syndrome, plozasiran, is being fast tracked.

SpringWorks To Make Its Case For Nirogacestat At High-Stakes EMA Meeting

 
• By Francesca Bruce

Nirogacestat was one of four products scheduled for an oral explanation meeting at the European Medicines Agency this week.

More from Pink Sheet Perspectives

US FDA’s Accelerated Approval Council: Bigger Role, More Transparency Coming?

 
• By Sue Sutter

The inspector general said the council should be more involved in specific approval decisions when there is internal disagreement, but FDA said that would preclude some individuals from adjudicating a subsequent withdrawal proceeding.

Confirmatory Trials: US FDA Expectations Become Clearer Amid FDORA Flexibilities

 
• By Sue Sutter

Two recent accelerated approval guidances describe the FDA’s policy expectations for trial timeliness, but recognize the need for case-specific determinations. Regulatory actions in 2024 show the FDA is willing to delay application filing or approval over confirmatory trial status.

Japan In 2025: Policy Give, Pricing Take Set To Continue

 
• By Lisa Takagi

While Japan looks set to further improve policies to support ventures and ease market entry this year, these will contrast with ongoing reimbursement price controls.