| Today (3 February), the European Commission has launched the first request submission period for joint scientific consultations (JSCs) under the Health Technology Assessment Regulation (EU) 2021/2282.The JSCs enable health technology developers (HTDs) to exchange information with regulatory authorities on their development plans for a medicinal product or medical device. They also enable HTDs to obtain guidance on the information, data, analyses, and other evidence that are likely to be required from clinical studies for the joint clinical assessment of those products. The JSCs are conducted by the JSC subgroup of the Member State Coordination Group for health technology assessment (HTA CG).The current request submission period runs from 3 February to 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) Further information: Joint scientific consultations Implementing act on joint scientific consultations on medicinal products Guidance for joint scientific consultationsFactsheet on joint scientific consultations |
In this article:
Click to comment
