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European Commission Prioritises Health Technology Assessment with New Scientific Consultations

In a move highlighting the critical importance of Health Technology Assessment (HTA), the European Commission has officially launched its first request submission period for joint scientific consultations (JSCs) under the Health Technology Assessment Regulation (EU) 2021/2282. This initiative underscores the Commission’s commitment to facilitating informed development and assessment of new health technologies.

The JSCs are designed to provide a valuable platform for health technology developers (HTDs) to interact with regulatory authorities. Through these consultations, developers can share their development plans for medicinal products or medical devices and receive essential guidance on the type of information, data, analyses, and evidence required for joint clinical assessments. The consultations are managed by the JSC subgroup of the Member State Coordination Group for HTA.

Developers can submit their requests for consultations between 3 February and 3 March 2025. In their requests, HTDs can apply for the following consultation slots for medicinal products:

  • Start of the procedure 2–5 June 2025 (Briefing document by 5 May 2025)
  • Start of the procedure 7–10 July 2025 (Briefing document by 2 June 2025)
  • Start of the procedure 1–4 September 2025 (Briefing document by 7 July 2025)

This initiative highlights the Commission’s proactive role in ensuring that developments in health technology are rigorously assessed, thereby maintaining high standards of safety and efficacy in healthcare innovations.

The EDiHTA consortium recognises the vital importance of providing the EU life science ecosystem with a new and innovative framework — one that thoroughly integrates the diverse perspectives of users in Digital Health Technologies (DHTs), including DHTs. We aim to support technology developers by accelerating the path to market access for DHTs. EDiHTA will provide relevant guidance on the requisite evidence for each DHT and TRLs  –  contributing to the goal of providing European citizens with faster access to safe and effective technologies, while also increasing trust in these innovations.

For further information and to apply, follow this link.

Funded by the European Union (GA no. 101136424). Views and opinions expressed are however those of the author(s) only and do not necessarily reflect those of the European Union the European Health or the Digital Executive Agency (HADEA). Neither the European Union nor the granting authority can be held responsible for them.
The UK participant is supported by UKRI grant No 10106869 (National Institute for Health and Care Excellence).
The Swiss participant is supported by the Swiss State Secretariat for Education, Research and Innovation (SERI).

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