Joint clinical assessment of medicinal products: Submission of early information by health technology developers
After 12 January 2025, medicinal products falling under the scope of Article 7(2), point (a) of Regulation (EU) 2021/2282 (the HTA Regulation) will be subject to a Joint Clinical Assessment (JCA). The EMA published guidance on 21 June 2024 to applicants/health technology developers on how to declare in the EMA Letter of Intent whether their application falls under the scope of the Health Technology Assessment Regulation ((EU) 2021/2282 Article 7) and, therefore, is subject to JCA.
Read the news announcement published by EC Directorate-General for Health and Food Safety on 21 June 2024.
OpenEdition vous propose de citer ce billet de la manière suivante :
lsgilbert (8 juillet 2024). Joint clinical assessment of medicinal products: Submission of early information by health technology developers. ELSIBI. Consulté le 7 octobre 2026 à l’adresse https://doi.org/10.58079/11ymq
