Overview of our services Strategic advice Regulation (EU) 2021/2282 Article 7 (1) of Regulation (EU) 2021/2282 specifies when a health technology must undergo a Joint Clinical Assessment (JCA). Paragraph 1a stipulates that the time of initial market authorization application (MAA) is decisive. A JCA of the new health technology only needs to be
EUnetHTA21 offers early dialogue Joint Scientific Consultations (JSC) in parallel to the EMA scientific advice for medicinal products which are to undergo the EU Joint Clinical Assessments starting in 2025. In 2022, five JCS slots are available. Health technology developers can apply for a JCS during the open call from June 6 to August 31,
The first medicinal products used to treat oncologic diseases and ATMPs will be assessed within the framework of the Joint Clinical Assessments on the level of the European Union (EU) starting in 2025. Until then, the necessary health technology assessment (HTA) process needs to be defined and refined. Today, we were honored to present our
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