The HMA initiative “clinical trial applications advice pilot”, coordinated by the CTCG, will become a permanent initiative from January 2027. This pilot, developed in close collaboration with the European Medicines Agency (EMA), provides clinical trial sponsors with coordinated technical and regulatory guidance before the submission of clinical trial applications through the Clinical Trials Information System (CTIS). Since its launch in 2024, the initiative has strengthened cooperation across the European medicines regulatory network, helped sponsors improve the quality of their applications through consolidated feedback from participating Member States, and contributed to more efficient clinical trial assessment processes across the European Union.