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
The German Federal Ministry of Health has published a draft law on the financial stabilization of the statutory health insurance (GKV-FinStG). The subjects of the draft are amendments to the Social Code Book V, in particular Articles § 35 a and § 130 b, which include the early benefit assessment of new active substances and
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