More Work Needed On GDPR And CTR Interplay, Says EU Pharma

Various EU member states have taken different positions on the General Data Protection Regulation when it comes to whether consent should be the only legal ground for processing clinical trial data. Pharma companies have welcomed the European Data Protection Board's recent opinion on this topic, but say that more work is needed to support a harmonized approach. 

Directions
EU Countries Are Applying The GDPR Inconsistently For Health Research • Source: Shutterstock

The European Data Protection Board's recent opinion on the interplay between the Clinical Trials Regulation and the General Data Protection Regulation provides some "welcome clarification" on the relationship and the legal basis under which trial data may be processed in compliance with the GDPR, but "a great deal more needs to be done" on this front, the pharmaceutical industry has said.

Ever since the GDPR came into force in May 2018, various EU member states have taken contradictory approaches to how...

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

More from Europe

More from Geography

‘Prices Can Remain Contaminated Indefinitely’: Advanz Brushed Aside On UK Liothyronine Appeal

 
• By 

England’s Court of Appeal has upheld a Competition Appeal Tribunal’s 2023 finding that Advanz and its former owner Cinven abused their dominant position in the UK market for liothyronine tablets by charging prices that were many orders of magnitude higher than the benchmark for fair pricing.

New EU Filings

 

Linerixibat, GSK's treatment for cholestatic pruritus in patients with primary biliary cholangitis, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.

Podium Policy Returns To US FDA, Or Is It Podcast Policy?

 

US FDA critics have long decried the practice of using informal communications to convey regulatory expectations as podium policy. In the Makary era, the phrase may need to be updated because the agency now seems to be specializing in policy by podcast.