The European Commission has released its fourth implementing act titled “Health Technology Assessment – Joint Scientific Consultations on Medicinal Products for Human Use” for public consultation. This important document outlines how health technology developers can seek early guidance on the evidence and data required for conducting a joint clinical assessment (JCA) of their products.
Key aspects covered by this Regulation include:
- Details on how health technology developers can request Joint Scientific Consultations (JSCs)
- Parallel Consultation with the European Medicines Agency
- Deadlines and procedures for various stages, such as submitting the draft and final briefing package, sending the list of issues, sharing the final briefing package with individual experts, and delivering the JSC outcome document
- Selection and involvement of individual experts and stakeholder organisations
- Correspondence during JSCs on medicinal products and use of the HTA IT platform
- Data protection and confidentiality
This draft act is open for feedback for four weeks, until 29 October, after which the final document will be prepared for implementation.
So What?
This draft document is crucial for health technology developers seeking to engage with EU-level experts for advice prior to the formal JCA of their products. Once feedback is incorporated, the final act is expected to come into effect on 12 January 2025, facilitating the JSC framework under Regulation (EU) 2021/2282 for medicinal products for human use.
Stay tuned—next week, Remap will provide an in-depth analysis of this fourth implementing act, exploring its implications for health technology developers.
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