The first Joint Clinical Assessment (JCA) submissions under the HTA Regulation are underway. For new cancer medicines and ATMPs, since January 2025 the Regulatory submissions through the centralised procedure to the European Medicines Agency (EMA) will also trigger the JCA process. Both processes will run in parallel and the new legislative framework for exchange of information between regulators and HTA will take effect. The new process will require a close collaboration between the regulatory and HTA/market access teams at company level.

This course will discuss regulatory preparedness for the JCA process, explain the interface between regulators and EU HTA Coordination Group and which information is shared by the two.

It will inform you about practical strategic and operational challenges and how to solve them. Preparation early on in development is key, hence two workshops in small groups will focus on the role of prospective evidence planning/Joint Scientific consultation and the operational aspects of writing and submitting the JCA dossier.

The instructors have been very close to the HTA Regulation implementation activities in companies and with the policymakers.