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

EMA Updates Pre-Authorization Procedural Advice To Cover Joint Clinical Assessments

 
• By Francesca Bruce

Two new pieces of guidance, from the EMA and the HTA coordination group respectively, should help companies understand which drugs must undergo an EU-wide joint clinical assessment and how to notify the relevant authorities about them.

Compass
New guidance offers developers direction on joint clinical assessments • Source: Shutterstock

The European Medicines Agency has updated its procedural guidance for developers that need to declare that their products will be subject to forthcoming EU-level joint clinical assessments (JCAs), including advice on ensuring that the pre-submission phase for both JCAs and marketing authorization applications (MAAs) can begin at the same time.

Meanwhile, the EU's Member State Coordination Group on Health Technology Assessment (HTACG) has published a guide to help developers identify...

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

Semaglutide: EMA Safety Probe Confirms Rare Eye Disorder Risk

 
• By Neena Brizmohun

The EU product information for Novo Nordisk’s semaglutide medicines is to be updated to include non-arteritic anterior ischemic optic neuropathy as a side effect with a frequency of “very rare.”

Infographic: Leqembi – A Geographical Comparison

 
• By Anabel Costa-Ferreira

The Pink Sheet explores how regulatory approvals for Leqembi differ around the world, and looks at what is coming next.

To Compete With China, US FDA Must Deregulate Early Gene Therapy Studies, CAR-T Inventor Says

 
• By Sarah Karlin-Smith

FDA regulation was painted as an obstacle to US dominance in the cell and gene therapy space even as panelists at an agency event praised the Office of Therapeutic Products' track record under Nicole Verdun.