EU Biotech Act would rebuild CTIS for faster multinational trials

The European Union's proposed Biotech Act would change about 70% of the system that every clinical trial in the EU runs through, the European Medicines Agency (EMA) has told its Management Board. The EMA says the first changes to the bloc's clinical trial rules could apply as early as 2028, and that work on a new version of the Clinical Trials Information System (CTIS) will start in early 2027.

The update is in the highlights of the EMA Management Board's September 2026 meeting, published on 1 October 2026. It comes as a separate pilot, FAST-EU, tests whether multinational trials can be authorised within 70 days under the current rules.

What CTIS is

CTIS is the single online system through which sponsors apply to run clinical trials in EU and European Economic Area countries, and through which national regulators and ethics committees assess them. It underpins the Clinical Trials Regulation, which replaced a patchwork of national processes.

According to the EMA, since its launch in 2022 CTIS has supported the authorisation and management of more than 14,000 clinical trials in Europe, and receives more than 200 new trial applications each month. That load keeps growing. A modernisation initiative started in 2025 to prepare the system for it.

The EMA says CTIS makes the Clinical Trials Regulation work in practice, supports cross-border collaboration, and increases transparency and public trust in medicines development.

What the Biotech Act would change

The European Commission adopted its proposal for a Biotech Act in December 2025. The proposal is now being discussed by the Council and the European Parliament.

The EMA says the proposed changes to how trials are authorised and supervised affect "approximately 70% of the current CTIS functionality." They include:

• faster clinical trial assessments
• more flexibility for major modifications to ongoing trials
• stronger collaboration between member states
• more proportionate, risk-based authorisation procedures
• common medicinal product dossiers
• simpler assessment of combined studies involving medicines, medical devices and in vitro diagnostics

The last point addresses a long-standing complaint. Trials that test a medicine alongside a device or diagnostic test can currently face separate assessments under different EU laws.

The timetable

The EMA described the legislative timetable as ambitious. "According to the ambitious timeframe set for the legislative procedure, first changes to the clinical trials regulation could already come into force in early 2028," it said.

The European Commission, supported by Board members, "expressed urgency for EMA to advance preparations." The Board stressed the importance of delivering key CTIS functions, including accelerated assessment timelines, as early as possible.

The EMA's plan has two tracks:

• immediate investment in the current CTIS platform, so it can deliver priority changes in time
• a new, modern CTIS platform to deliver all the trial functions foreseen by the Biotech Act, with work starting in early 2027

A detailed roadmap, including the resources needed, will go to the Board in December 2026.

FAST-EU, a test under current rules

While the Biotech Act moves through the legislative process, regulators are already testing faster multinational authorisation. FAST-EU was launched in February 2026 within the existing Clinical Trials Regulation and CTIS. It is run by the Clinical Trials Coordination Group, which brings together national regulators, and MedEthics EU, which brings together ethics committees.

According to a Heads of Medicines Agencies update published on 20 May 2026:

• 68 expressions of interest were received
• 15 trials were selected
• 7 of those are in oncology and haematology, 2 in neurology, 2 in cardiovascular and pulmonary vascular disease, and 2 in immunology
• the selected trials involve an average of 7.33 member states each, and up to 14
• the first three procedures met or came close to the 70-day target

The pilot's design includes validation carried out in parallel across countries and a single round of requests for information on Part I of the application, which covers the scientific and medicinal product aspects assessed jointly by member states.

The Austrian medicines agency AGES, one of the national regulators taking part, has published its own update on the pilot.

Why speed matters in Europe

European regulators and policymakers have argued that the EU has been losing share of global clinical trials to the US and Asia. Multinational trials in the EU can involve many national regulators and ethics committees, each with questions, even under the single CTIS process.

Faster and more predictable authorisation is meant to make the EU more attractive to sponsors. For patients, that could mean more trials open in more countries.

How it fits with other EU reforms

The Biotech Act is separate from the EU pharmaceutical package, which the Council adopted on 28 September 2026 and which changes regulatory protection periods, orphan incentives and EMA assessment times for marketing authorisations. The pharmaceutical package also offers an extra year of market protection for medicines that meet criteria including trials run in more than one member state. We cover it in our article on the EU pharma package.

The EMA's September Board meeting also noted progress on preparing for the pharmaceutical package, with priority given to early measures such as transferable exclusivity vouchers for priority antibiotics, a regulatory sandbox and the management of shortages.

How it compares with the UK and US

Other regulators are also moving to speed up trial approvals. In the UK, new clinical trials regulations took effect on 28 April 2026 with a combined MHRA and ethics review, and the MHRA's Strategy 2030 promises a 14-day initial assessment for first-in-human trials. See our article on the UK regulations at six months.

In the US, the FDA opened applications in September for an Expedited IND Pilot to speed up first-in-human trials. See our article on the FDA Expedited IND Pilot.

Open questions

Several questions remain as the Biotech Act is negotiated:

• how far assessment timelines will be cut in the final text
• how risk-based procedures will decide which trials get lighter review
• how the combined assessment of medicines, devices and diagnostics will work in practice
• whether national regulators and ethics committees have the staff to meet shorter deadlines
• how quickly the EMA can deliver the CTIS changes, given that the new platform work only begins in 2027

The final shape of the trial provisions depends on negotiations between the Council and Parliament.

What it means for patients

If the reforms work, patients in Europe could see more trials open, more of them running across several countries, and less delay between a trial being designed and its first participant being enrolled. Safety and ethics review remain part of every authorisation. CTIS also publishes information about trials, which patients can search on the EU's public clinical trials website.

Our guide on how to find and join a clinical trial explains how to search EU, UK and US registries.

What happens next

The EMA will present its detailed CTIS roadmap to the Management Board in December 2026, and work on the new platform is due to start in early 2027. The Biotech Act remains under negotiation, with first changes to the clinical trial rules possible from early 2028. FAST-EU continues to run under the current rules.

Related reading

• EU Council adopts pharma package with new data protection rules
• MHRA Strategy 2030 targets faster approvals and trials

This article is for general information and is not medical advice. Please talk to your own doctor before joining a trial or changing any treatment.