EU HTA Regulation: Guidance Released On Joint Clinical Assessment Scoping & Reporting

The European Commission’s Member State Coordination Group on HTA has released two new guidance documents aimed at helping member states and assessors to navigate joint clinical assessments under the Health Technology Assessment Regulation.

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Joint clinical assessments (JCAs) are one of the most important elements of the EU Health Technology Assessment (HTA) Regulation, which will enter into force from January 2025, initially for new cancer medicines and advanced therapy medicinal products that are granted marketing authorizations by the European Commission.

The Member State Coordination Group on HTA (HTA CG), which was established under the new regulation, recently adopted two guidance documents focused on

Key Takeaways
  • The HTA CG, established under the new EU HTA Regulation, has published guidance for member states and assessors around the scoping and reporting of JCAs, a key part of the new regulation.

  • The information is valuable for pharmaceutical companies as it can be used to help them prepare their JCA dossiers

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