On the 23 September 2025, the European Commission (EC), Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) announced two new targets for clinical trials in the EU.
- Within five years, they aim to see 500 additional multinational clinical trial authorisations added to the current number; and
- 66% of trials should begin patient recruitment within 200 calendar days of the application submission date.
The new targets are part of a larger project to build a more supportive environment for clinical research within the EU, following the enactment of the Clinical Trials Regulation ((EU) No 536/2014) (the CTR), which became fully applicable across the EU/EEA on 31 January 2025.
In this article we address five important questions that sponsors should consider before they conduct a clinical trial in Ireland under the new regime.
1. What are the core changes under the EU CTR and why do they matter?
The CTR replaces the previous EU Directive with a single, directly applicable regulation. The key changes include:
- A harmonised, EU-wide process: The CTR establishes a single, streamlined application procedure via the EU's Clinical Trials Information System (CTIS). Sponsors no longer face divergent national requirements; a single online submission can now cover all EU countries selected for a trial, greatly simplifying the launch of multi-country studies.
- A single, coordinated approval: The regulation introduces a single combined authorisation procedure. One Member State leads a coordinated scientific review with the others participating in a common assessment. Each country then issues a single national decision based on this shared evaluation.
- Greater transparency: The CTR mandates a high degree of transparency. Most documents submitted to CTIS, including protocols and results summaries, will be made publicly accessible by default on the EU database.
These changes matter because they reduce administrative duplication and provide faster access to trials for patients. However, the unified system means that an application dossier must be of high quality from the outset to satisfy all concerned countries simultaneously.
The transition period for the CTR ended on 31 January 2025, so all trials must now be conducted under the CTR.
2. What are the Irish-specific considerations under the CTR?
The CTIS portal is now the mandatory single-entry point for all new clinical trial applications in Ireland. It serves as a unified workspace for all regulatory tasks, from initial submission to progress reporting, safety updates, and the final posting of trial results. Both the application and review occur through this portal.
Under the CTR, Ireland has moved to a centralised regulatory-ethics review model, managed jointly by the HPRA and the National Office of Research Ethics Committees. On receipt of an application through the CTIS, the HPRA handles the scientific review (Part I) while the NREC handles the ethical and site-specific review (Part II). While sponsors previously had to seek separate approvals from local ethics committees, the NREC now assigns one of its National Research Ethics Committees to each clinical trial.
The process culminates in a single "National Decision" issued by the HPRA on behalf of both bodies, providing a unified and efficient outcome for the sponsor. This system was proactively piloted in Ireland and is now a core feature of the country's streamlined approval process.
Key considerations for sponsors include:
- Language requirements: Documents must be in plain English and meet Irish data protection standards. Documents no longer require an Irish (Gaeilge) translation, simplifying the process.
- Investigator and site suitability: The application must include evidence of qualified investigators and appropriate clinical sites.
- Insurance and indemnity: Ireland mandates a compensation policy for trial-related injuries. Proof of adequate insurance or indemnity must be included in the CTIS submission and is a prerequisite for approval. While CTR defines the standard dossier, sponsors must ensure the inclusion of this Irish-specific documentation.
In Ireland, breaches of the CTR can lead to significant enforcement action, including fines up to €300,000 or a three-year imprisonment for serious offenses.
3. What data protection and transparency obligations apply?
The CTR works in tandem with the GDPR, and Irish law confirms that national privacy laws continue to apply alongside the CTR. Sponsors must have a lawful basis for processing personal data, implement safeguards such as pseudonymisation, and ensure their informed consent processes are fully compliant.
Regarding transparency, sponsors must be prepared for most trial documents submitted to CTIS to be publicly disclosed by default. Key obligations include:
- Uploading a summary of trial results to the public database within 12 months of trial completion.
- Providing a lay-language summary of the results for the general public.
The original text of the CTR created deferral and redaction mechanisms for the publication of clinical trial documentation. In October 2023 these rules were revised in response to feedback from stakeholders. The revised Transparency Rules replace the earlier mechanism with an option to create two versions of the documentation: one “for publication” with redactions for sensitive information, and one “not for publication” without any redactions, which can be used for review by the member state body. These new rules are binding for all sponsors of clinical trials in the EU.
To further the CTR goal of greater transparency, all sponsors not established in the EU/EEA (e.g., a US or UK-based company) must appoint a legal representative within the EU/EEA. This is a mandatory requirement for conducting a trial in Ireland.
4. How can sponsors ensure compliance across multi-jurisdictional EU trials?
Success in multi-country trials under the CTR requires careful coordination and a centralised strategy. Sponsors should:
- Centralise trial management: Use a central team to oversee the CTIS submission for all countries, ensuring the dossier simultaneously meets each country's specific requirements.
- Manage timelines rigorously: CTIS imposes strict, harmonised deadlines. For example, missing an RFI deadline for one country can cause the application to be withdrawn for all countries involved.
5. What strategic advantages does Ireland offer for clinical R&D post-CTR?
With the CTR fully implemented, it is important to choose a strong member state to lead the review. Ireland offers several key advantages, including:
- Efficient and respected regulatory environment: The coordinated HPRA-NREC review provides a streamlined, single-decision process.
- World-class infrastructure and talent: Ireland is home to leading research hospitals, experienced investigators, and a high concentration of global life sciences companies, including major CROs like ICON plc.
- Favourable R&D incentives: The R&D tax credit allows companies to claim a 30% credit on qualifying R&D expenditures, including clinical trial costs, effectively lowering the net cost of research. Ireland also does not place a fee on non-commercial sponsors.
In 2024, the HPRA and NREC authorised 82 clinical trials under the CTR, and this number is expected to grow now that the new regulation is mandatory and fully applicable. This legislative reform supports Ireland’s commitment to become a top destination for clinical research.
As you navigate the complexities of the EU CTR in Ireland, consulting with experts deeply familiar with the local regulatory landscape is crucial.
A&L Goodbody's Life Sciences and Healthcare Regulatory teams provide strategic counsel on trial compliance and can assist in establishing your Irish operations to leverage Ireland's pro-research environment.
For more information in relation to this topic, please contact Cliona Christle, Partner or your usual A&L Goodbody Life Sciences contact.
