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-wideTwo pilot initiatives launched to coordinate scientific advice between clinical trial approval and design, and pre-clinical trial application regulatory advice, continuing into 2026.
ACT EU - Accelerating Clinical Trials · EU-wideRecommendations to streamline authorisation of new clinical trials and changes to ongoing trials during public health emergencies.
ACT EU - Accelerating Clinical Trials · EU-wideNew scientific advice approach combining clinical trial and ethics expertise to accelerate medicines development for emergencies and antimicrobial resistance.
ACT EU - Accelerating Clinical Trials · EU-wideCall for nominations to the Multi-stakeholder Platform Advisory Group, open until 30 October 2026, to improve the clinical trials environment.
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-wideStakeholder organisations invited to nominate representatives for the ACT EU Multi-stakeholder Platform Advisory Group; deadline 30 October 2026.
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 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-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-wide19 multinational clinical trials authorised above historical average; 40.5% of trials recruit participants within 200 days.
ACT EU - Accelerating Clinical Trials · EU-wideACT EU aims to facilitate activities on methodological aspects for clinical trials. In order to reach this goal, the objectives of the work are to: These objectives ensure that all relevant EU expert groups pool their...
ACT EU - Accelerating Clinical Trials · EU-wideEU aims to authorise 500 additional multinational clinical trials over five years.
ACT EU - Accelerating Clinical Trials · EU-wideImplementation of the Clinical Trials Regulation
ACT EU - Accelerating Clinical Trials · EU-wide