Joint Clinical Assessments: How The EMA Will Work With EU Member States On Information Exchange

The European Commission has published draft procedures for how the European Medicines Agency is to share information relating to joint clinical assessments with the Member State Coordination Group on HTA.

Information Exchange
New Draft Implementing Act Focuses on Information Exchanges for Joint Clinical Assessments • Source: Shutterstock

The European Commission is consulting on the next implementing act in preparation for the forthcoming EU-level joint clinical assessments (JCAs) introduced under the 2022 Health Technology Assessment Regulation.

This draft act focuses on information exchange with the European Medicines Agency and is the third of six that will...

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

Engage With HTA Body NICE Before Submitting MAA, UK Govt Tells Companies

 

The government has explained how to navigate the UK’s regulatory and market access funding mechanisms.

EU Pharma Reform: Council Wants Strengthened Member State Powers On Drug Supply

 

The Council of the EU’s vision for the pharma reform package includes a stronger role for member states regarding the supply of medicines and the prevention of indication-stacking for orphan drugs.

EU Sees Unified Pathway For Drug/IVD Studies As Key To Future Research Investment

 
• By 

As the EU tests the feasibility of a radical “all-in-one” procedure for combined drug and IVD studies, sponsors are being urged to approach this novel framework with flexibility and openness.

EU CHMP Opinions And MAA Updates

 

This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.

More from Geography

Quotable: Top Experts On Policy Hot Topics

 

The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.

ACIP ‘Pivot’ May Mean Variable US Coverage For New Vaccines, Higher Copays

 
• By 

Clarity on payer responses to controversial vaccine recommendations from the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices may be coming.

CAR-T Therapy Trials Involving Chinese Labs Will Face Heightened US FDA Scrutiny

 

The FDA wants to ensure participants in clinical trials involving genetic engineering done in China understand what the agency sees as privacy and security risks. The agency also wants cell therapy processing done outside of “hostile” countries.