1. Pink Sheet
  2. >>Geography
  3. >>Europe

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)
Key Takeaways
  • The European Commission is planning to propose a Critical Medicines Act soon to tackle the EU’s reliance on imports of active pharmaceutical ingredients and finished medicines from Asia.
  • The Council of the EU is expected to begin formal discussions for the Critical Medicines Act on 13 June.
  • The council is also expected to discuss the EU’s pharmaceutical package of reforms at the 13 June meeting.
  • The council’s new Polish presidency said it would continue the previous presidency’s efforts to clinch a deal on a general approach on the two files of the pharmaceutical package, as comprehensive drug safety is among its priorities.
  • Lawyer, Elisabethann Wright, says that the question remains as to whether either the pharmaceutical reform package or the proposed Critical Medicines Act will be a priority for the Polish presidency.
  • She adds that the suggestion that any anticipated progress for the pharma package would be limited to having a deal concerning a general approach to the two files would indicate that any progress may be limited.

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

The act will aim to tackle severe shortages of essential medicines in the EU by reducing the bloc’s reliance on imports of active

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
Start Free Trial

Already a subscriber?

More from Europe

ClinicalTrials.gov Or ISRCTN: Getting Transparency Right For UK Trials

 
• By Vibha Sharma

ISRCTN’s systems are being redesigned to facilitate compliance with upcoming requirements in the UK’s clinical trials legislation.

Spain Slashes Wait Between EU Drug Authorization And Financing Decisions

 
• By Francesca Bruce

Spanish authorities say that that timelines for drug reimbursement decisions can be improved further with the right submissions from companies.

Spain Beats England To Tevimbra Reimbursement Recommendations

 
• By Francesca Bruce

Spanish authorities have published more pricing and reimbursement reports as part of a new drive to increase transparency.

Commission Taking ‘Due Account’ Of Scathing Report On EU Clinical Trial Bottlenecks

 
• By Vibha Sharma

A report by the European pharmaceutical industry criticizes the EU’s clinical trials framework, highlighting regulatory fragmentation, inefficiencies and the need for targeted reforms.

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.