Clinical trial applications advice pilot becomes permanent

EMA reports that the ACT EU advice pilot will become permanent from January 2027, continuing technical and regulatory support for sponsors preparing clinical trial applications. The procedure, coordinated by HMA through CTCG, provides feedback from the Member States concerned before submission through CTIS.

Why it matters: EMA says sponsors will retain access to coordinated pre-submission support, with updated guidance and templates available in January 2027.