The first ever Joint Clinical Assessment (JCA) submissions under the HTA Regulation are about to start. Regulatory submissions through the centralized procedure after 12 January 2025 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. The instructors have been very close to the HTA Regulation implementation activities in companies and with the policymakers.