HM8: How the new EU regulation on health technology assessment (HTA) will change clinical drug development and regulatory affairs
Key points:
- The new European Health Technology Assessment Regulation (HTAR) needs health technology assessment (HTA) requirements to be considered at an earlier stage of medicinal product development. HTA and regulatory activities need closer integration during both the drug development and registration process in the EU
- Joint scientific consultation (JSC) and joint clinical assessment (JCA) are the two products of HTAR. It is important for regulatory professionals to understand these frameworks to ensure better collaboration and more streamlined processes
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