ACT EU initiative identifies regulatory and operational bottlenecks for non-commercial clinical trial sponsors and establishes support measures including a helpdesk for CTIS navigation and regulatory guidance.
ACT EU - Accelerating Clinical Trials · EU-wideNew guidance documents published to support sponsors implementing the Clinical Trials Regulation, addressing frequent assessment issues and decentralised trial elements.
ACT EU - Accelerating Clinical Trials · EU-wideEU-wide call for participation in COMBINE pilot coordinated assessment programme; expressions of interest open until 31 August 2025.
ACT EU - Accelerating Clinical Trials · EU-wideEU Clinical Trials Information System designated as WHO primary registry to facilitate data sharing and promote transparency in clinical research.
ACT EU - Accelerating Clinical Trials · EU-wideReport from the third annual ACT EU Multi-stakeholder platform meeting (29 October 2025) summarising discussions on patient-centred research, methodologies, biotechnology, AI, digitalisation and ethics to inform workplan revision.
ACT EU - Accelerating Clinical Trials · EU-wideEU regulatory network publishes statistics and progress reports on Clinical Trials Regulation implementation and CTIS usage across EU/EEA.
ACT EU - Accelerating Clinical Trials · EU-wideACT EU published its 2026-2027 workplan aligned with updated objectives, informed by the proposed Biotech Act, Clinical Research Investment Plan and EU4Health initiatives.
ACT EU - Accelerating Clinical Trials · EU-wideACT EU initiative to collect stakeholder use cases and research priorities for analysis of clinical trial data from regulatory registers and CTIS.
ACT EU - Accelerating Clinical Trials · EU-wide