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

Radical Shake-Up In Store For Entire EU Pharma Legislation

Commission Proposals Tackle Regulation, Pricing, Shortages, Innovation – And Much More

 
• By Ian Schofield

The EU pharmaceutical strategy published on 25 November will be the first step in a “complete overhaul” of the medicines legislative framework to be proposed in about two years’ time, says the European Commission.

Resilience
The EU pharma strategy is intended to make the sector more resilient in future • Source: Shutterstock

The new EU pharmaceutical strategy presented today encompasses a whole raft of proposed legislative and regulatory changes, such as the streamlining of drug approval procedures, better access to affordable medicines, and strengthened EU-level cooperation on pricing and reimbursement.

On the cards are measures to boost competition from cheaper generic and biosimilar drugs, align clinical trials to patient needs,...

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

UK-Wide Strategy Needed To Move Clinical Trial Diversity Plans To Next Stage

 
• By Vibha Sharma

The UK’s research-based pharma industry and medical research charities have set out clear action points to drive greater diversity and inclusion in clinical trials.

Blenrep’s Comeback Continues As England Becomes First To Fund Drug

 
• By Eliza Slawther

Blenrep, GSK’s multiple myeloma therapy, faced a major setback when it was withdrawn from the market in 2022. The drug has since made a return as a second-line therapy, and is on track to being reimbursed in England.

Pharma’s Protests Fall Flat As UK Locks In High Rebate Rates

 
• By Neena Brizmohun

Despite pushback by industry, the government is standing by its new statutory scheme rebate rates for branded medicines, including one that doubles the rate that companies must repay on the sales of newer products to the National Health Service to 31.3%.

EUCOPE Wants Simpler Manufacturing Rules And Framework For Combined Trials Under EU Biotech Act

 
• By Eliza Slawther

EU authorities must “take advantage” of the upcoming Biotech Act to reassess the bloc’s policies and “offset existing challenges” for small and midsized enterprises, trade association EUCOPE has said.

More from Geography

Recent And Upcoming FDA Advisory Committee Meetings

 
• By Sue Sutter

Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.

UK-Wide Strategy Needed To Move Clinical Trial Diversity Plans To Next Stage

 
• By Vibha Sharma

The UK’s research-based pharma industry and medical research charities have set out clear action points to drive greater diversity and inclusion in clinical trials.

Blenrep’s Comeback Continues As England Becomes First To Fund Drug

 
• By Eliza Slawther

Blenrep, GSK’s multiple myeloma therapy, faced a major setback when it was withdrawn from the market in 2022. The drug has since made a return as a second-line therapy, and is on track to being reimbursed in England.