At both a national and EU level, measures have been taken over the past number of years to strengthen the European regulatory system and to ensure confidence, continued quality and safety. Enhanced competitiveness and speed of access by patients to therapies are key drivers. The proposal for a Biotech Act, published by the European Commission in late 2025 will also make important changes in the clinical trials regime.
Ireland
In June 2024 the National Clinical Trials Oversight Group (“NCTOG”) was established to examine the clinical trials landscape in Ireland, with a purpose of supporting improved clinical outcomes through increasing the number of trials taking place in Ireland. In November 2024, the NCTOG issued an interim report outlining three priority recommendations relating to pre-agreed model contracts, cost standardisation and data protection. The NCTOG’s final report, published in November 2025, entitled, “Transforming Ireland’s Clinical Trials Landscape” (the “Report”) outlines how it envisages attaining these goals through six key recommendations:
- The implementation and development of a national clinical trials body
- The creation of agile and responsive systems
- Enhancing patient and public engagement
- Promoting value and incentivising activity
- Strategic workforce development
- Promoting the use of innovative technologies
If implemented, it is hoped that these recommendations will enable the State to improve patient access to life-saving therapies and strengthen the resilience and quality of healthcare delivery, whilst simultaneously enhancing Ireland’s global reputation as a leading location for research and innovation. It is expected that the Clinical Trials Advisory Council (“CTAC”) will be created by early 2026, to ensure that the recommendations are implemented before the establishment of a National Clinical Trials Body by Q3 2027.
In addition, the revised Clinical Trial Agreement contract templates across trial models published in recent years have been in use for a sustained time now (read our previous briefing: HSE and IPHA announce model Clinical Trial Agreement for tripartite clinical trials) which should be helping to reduce the lead in time for trials getting off the ground.
The EU
End of the Clinical Trials Regulation transitional period
The beginning of 2025 marked a significant milestone for the EU clinical trials framework. The transitional period for clinical trials authorised under Directive 2001/20/EC on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use (the “Clinical Trials Directive”), concluded on 31 January 2025, requiring all ongoing clinical trials to migrate to Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use (the “Clinical Trials Regulation”). From that date, all active trials have had to operate fully under the Regulation and be managed through the Clinical Trial Information System (“CTIS”).
This shift represents a substantial change for sponsors. CTIS is intended to act as a single EU-wide portal and database, centralising submissions and communications while supporting greater transparency and harmonisation across Member States.
The EU also intensified its compliance focus during 2025, issuing reminders to sponsors who had not met the results‑posting obligations under the Clinical Trials Regulation. This initiative led to a substantial increase in posted trial results across the EU/EEA, although a number of non‑compliant trials remain listed on the EU Clinical Trials Register.
Updated EMA guidance on CTIS
To support sponsors during this transition, the European Medicines Agency (the “EMA”) published updated CTIS guidance in November 2025. This guidance provides detailed direction on the use of CTIS, including:
- Application processes and technical functionality
- User access and role management
- Compliance expectations under the Clinical Trials Regulation
It also sets out the EMA’s approach to commercially confidential information and personal data protection within CTIS – issues that remain critical for sponsors navigating publication obligations and data disclosure.
The EU also intensified its compliance focus during 2025, issuing reminders to sponsors who had not met the results‑posting obligations. This initiative led to a substantial increase in posted trial results across the EU/EEA, although a number of non‑compliant trials remain listed on the EU Clinical Trials Register.
EU Life Sciences Strategy
In July 2025 the European Commission unveiled its strategy entitled, ‘Choose Europe for Life Sciences’, setting out an ambition for the EU to become the world’s most attractive location for life sciences by 2030 (the “Strategy”) (read our previous briefing: Towards 2030: The EU’s vision for life sciences and food innovation | Arthur Cox LLP).
A central pillar of the Strategy is strengthening Europe’s clinical research ecosystem. As part of the Strategy, the Commission emphasised the need for sustained investment in research infrastructure, as well as the continued development of high-quality clinical trial centres and cross-border research networks.
Key measures include advancing multi-country clinical trials through European partnerships, driving regulatory, technological and process innovations through the Accelerating Clinical Trials in the European Union (“ACT EU”) initiative, and encouraging Member States and other partners to scale up targeted research and innovation investment at local, regional and national levels. The Commission will monitor implementation of the Strategy, with a comprehensive progress report expected by 2028.
FAST-EU: A new fast track authorisation pathway
A further development occurred in November 2025 with the introduction of Facilitating and Accelerating Strategic Trials (“FAST-EU“) by a number of National Competent Authorities. FAST-EU is a collaborative initiative led by the Heads of Medicines Agencies (“HMA”), the Clinical Trials Coordination Group (“CTCG”) and MedEthicsEU.
The objective of FAST-EU is to streamline the authorisation process for multi-national clinical trials. The pathway offers a 10-week maximum end-to-end timeline from CTIS submission to final conclusion and facilitates coordinated assessment across participating member states.
FAST-EU was announced in late 2025 and is also intended to serve as a structured learning mechanism to support the implementation of the forthcoming European Biotech Act.
Proposal for a Biotech Act
A significant legislative milestone occurred with the publication of the European Commission’s proposal for a European Biotech Act on 16 December 2025, representing potentially the most substantial update to the EU’s clinical research framework since the adoption of the Clinical Trials Regulation. The proposal introduces accelerated and simplified timelines for trial authorisations – reducing initial approval timelines from approximately 106 days to 75 days, and in some cases to 47 days where no further information is requested.
It also removes the existing extension period for advanced therapy medicinal products (“ATMPs“) and introduces a more risk‑proportionate regulatory approach, an EU‑level investigational medicinal product (IMP) core dossier, and clarifications on data‑processing rules under GDPR.
What this means for sponsors
Sponsors operating in the EU should ensure that they are fully aligned with the requirements of the Clinical Trials Regulation, including CTIS functionality, submission standards and disclosure rules. Those planning multi-national studies may wish to consider whether the FAST-EU pathway could offer strategic advantages.
As well as monitoring the impact of the EU Life Sciences Strategy, it will also be important to follow progress of the draft EU Biotech Act and the expected publication in 2026 of a domestic Life Sciences Strategy. These measures, as well as ongoing progress of the other measures set out in this piece, will undoubtedly impact the regulatory and policy framework in years ahead.
For more information contact our Life Sciences Group.
With thanks to Aoife O’Malley for her contribution to this briefing.
