Workplan and performance indicators
The ACT EU workplan for 2026 to 2027 was adopted in May 2026 and rests on seven revised objectives. By March 2026, 19 multinational trials beyond the historical trend had been authorised, against a target of 500 additional trials by 2030. 41% of trials met the recruitment target, against a goal of 66% recruiting within 200 days of application submission. Work continues on streamlining sponsor serious breach reporting, and consolidated advice for trials is being considered for a permanent pre-CTA offering.
Biotech Act
Council and Parliament discussions are progressing, with trilogues expected in early 2027. Measures relevant to clinical trials include:
- Shorter authorisation timelines and greater reliance on the reporting Member State assessment.
- Tailored procedures for public health emergencies and more harmonised data governance.
- Provisions supporting decentralised elements and the use of artificial intelligence.
The Commission’s supporting analysis estimates that the package could increase clinical trial activity in the EU by 10 to 30%.
EU4Health and ethics review
Two joint actions are planned: support for non-commercial sponsors, led by Czechia, and Clinical Trials Regulation implementation and capacity building, led by Austria. A EUR 10.9 million call to support one or two multinational trials using innovative approaches, including decentralised elements and artificial intelligence, is under discussion. MedEthicsEU has finalised a harmonised template for recruitment and informed consent, developed with the CTCG, and is working on conditional approvals. Members noted the wide variation in ethics committee resources across Member States.
Patient involvement
Follow-up on the 12 patient priorities continued with a meeting of the signatory organisations on 10 July. Disease-specific patient panels, co-created with patient organisations, are targeted for a pilot in the first quarter of 2027, when a workshop on patient experience data is also under consideration. An update is planned for the September meeting.
Nuclear medicine trials
A European Association of Nuclear Medicine survey identified regulatory complexity and fragmented requirements, limited funding, administrative burden, restricted access to novel radiopharmaceuticals, and infrastructure and staff shortages as the main barriers to non-commercial trials. Proposed remedies were regulatory harmonisation, dedicated funding, more centralised approval and stronger academic networks. Germany’s parallel assessment model was cited as useful for diagnostic studies, while therapeutic trials face further challenges.
Dates for stakeholders
- 30 September 2026: deadline for the Advisory Group feedback survey on mandate and working methods.
- 17 September to 29 October 2026: call for expressions of interest for the renewed Advisory Group, whose mandate begins in March 2027.
- Annual meeting postponed: the ACT EU MSP annual meeting in Amsterdam, planned for 22 October 2026, was postponed on 9 September 2026. The Advisory Group meeting on 18 September confirmed that it will now take place in early 2027.
Source: ACT EU Multi-stakeholder Platform Advisory Group, meeting highlights, 18 June 2026.
