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

EMA To Clarify Member State-Specific Requirements For New EudraVigilance System

 
• By Neena Brizmohun

Drug makers preparing for the launch of the enhanced EudraVigilance database in the EU will soon be told about any plans, arrangements and requirements that are specific to the national competent authorities.

European Union
Companies will learn about member state-specific Eudravigilance requirements • Source: Shutterstock

Europe’s enhanced EudraVigilance database for managing and analyzing suspected adverse reactions to authorized medicines is still on track to go live on Nov. 22, and drug companies should in September learn about any specific requirements the national competent authorities (NCAs) might have.

Marketing authorization holders (MAHs) and clinical trial sponsors will be given information on such things as the use of local...

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

More from Geography

HHS Wants Employees (And Public?) To Report Diversity, Equity And Inclusion Discrimination

 
• By Sue Sutter

A survey asks FDA staff to disclose whether DEI policies caused discrimination or resulted in disciplinary action against career employees over the past five years, but uses a web form that the general public also can access.

EU Health Chief Declares There Is No Better Alternative Than TEVs to Spark Antibiotic Innovation

 
• By Francesca Bruce

Clarity on what transferable exclusivity vouchers may look like for new antimicrobial drugs could be nearing. Denmark’s new presidency of the Council of the EU has prioritized concluding its negotiations with European Parliament over the legislative overhaul of the EU’s pharmaceutical legislation.

EU Fines Alchem Over Buscopan API Cartel

 
• By Dave Wallace

After pursuing Alchem International for breaches of EU antitrust rules – relating to a cartel over the SNBB pharmaceutical ingredient used in Buscopan and its generics – the European Commission has now hit the firm with a €489,000 fine.