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As Vote Nears, EFPIA Chief Sounds The Alarm Over Data Protection Cuts

 
• By Ian Schofield

Nathalie Moll says that the European Commission’s estimates of the costs to EU member states of regulatory data protection are “incorrect and over-estimated.”

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The European Commission wants to cut data protection to allow earlier access to cheaper generics • Source: Shutterstock

With a key parliamentary committee preparing to vote on revisions to the EU’s pharmaceutical legislation, European R&D-based industry group EFPIA has reiterated its concerns over a proposal to slice two years off the baseline period of regulatory data protection (RDP) in an effort to foster earlier generic and biosimilar competition.

The group has also taken issue with recent claims by the European Commission about the costs to the EU member...

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More from Europe

UK Needs Specialist Scientific Knowledge To Stay Competitive Post-Brexit, AstraZeneca Says

 
• By Eliza Slawther

A senior AstraZeneca executive says the UK MHRA must develop specialist expertise and create incentives for companies to file marketing authorizations nationally if it wants to stand out to strategic decision-makers.

Novel Alzheimer’s Drug Blarcamesine Scheduled For High-Stakes EMA Oral Explanation

 
• By Neena Brizmohun

The EMA has scheduled oral explanation meetings this week for Anavex’s blarcamesine and three other products that are nearing the end of the regulatory review cycle. These meetings usually represent the final chance for sponsors to persuade the agency that their product merits approval.

UK Targets Contamination Tests & Pharmacokinetic Studies In Animal Testing Phase Out

 
• By Eliza Slawther

Pharmaceutical companies will be expected to phase out certain animal tests in the drug development process under a UK roadmap aimed at pivoting towards using alternative models, such as organ-on-a-chip systems and artificial intelligence.

EU Moment Of Truth For Teplizumab, Etuvetidigene Autotemcel & Other Drugs

 
• By Neena Brizmohun

The sponsors of a number of drugs could this week learn whether the European Medicines Agency will recommend in favor of approving their products. And while teplizumab was approved in the US in 2022, Sanofi told the Pink Sheet why it waited to submit the drug for regulatory review in the EU.

More from Geography

‘Why We Would Do It Again’ – Gilead & Roche On Pioneering Global Initiative For Manufacturing Change

Gilead and Roche reflect on their experiences with a global initiative that delivered aligned regulatory decisions through joint hybrid inspections and synchronized review of post-approval changes.

Novel Alzheimer’s Drug Blarcamesine Scheduled For High-Stakes EMA Oral Explanation

 
• By Neena Brizmohun

The EMA has scheduled oral explanation meetings this week for Anavex’s blarcamesine and three other products that are nearing the end of the regulatory review cycle. These meetings usually represent the final chance for sponsors to persuade the agency that their product merits approval.

Hope For Stability, Credibility As US FDA Vet Pazdur Takes Over CDER

 
• By Sarah Karlin-Smith

The appointment of longtime FDA oncology leader Richard Pazdur to lead FDA's Center for Drug Evaluation and Research is being well received.