EMA Guidance: ETF Scientific Advice that facilitates Clinical Trial Authorisations (SA-CTA) and 2025–2027 IRIS Roadmap

The European Medicines Agency (EMA) recently published new guidance titled “Guidance for applicants: the ETF Scientific Advice that facilitates Clinical Trial Authorisations (SA-CTA)”, outlining how sponsors and applicants can benefit from harmonised scientific advice to accelerate clinical trial authorisation across the EU.

1. What the SA-CTA Scientific Advice Is

The guidance explains that the SA-CTA scientific advice is a specialised type of EMA advice developed under the mandate of the Emergency Task Force (ETF) to support medicines aimed at public health emergencies.The purpose of SA-CTA is to harmonise scientific expectations across EU regulatory bodies for both CTA and MAA development plans.

The guidance states that SA-CTA brings together the ETF, the Clinical Trial Coordination Group (CTCG), Member States (MSs), National Competent Authorities (NCAs), and an ethics expert group known as the Public Health Emergency Ethics Advisory Group (PHE EAG).

This creates a single, consolidated scientific advice platform that reduces discrepancies between Member States and accelerates clinical trial planning.

2. How SA-CTA Fits Within the EU Scientific Advice Landscape

According to the guidance, the EU offers several scientific advice routes, including standard EMA Scientific Advice (SAWP) and the SAWP/CTCG pilot.The SA-CTA, as explained in the guidance, is the formal route for advice when the product falls under the ETF’s remit, especially for pathogens with pandemic potential or declared public health emergency situations.

The guidance highlights that the SA-CTA shares similar principles with the SAWP/CTCG pilot but is a fully established, formalised procedure under EMA’s emergency preparedness framework.

3. Main Features of the SA-CTA Procedure

The guidance emphasises that applicants must use the IRIS platform to submit an SA-CTA request.The IRIS application form now includes specific fields for identifying whether the applicant seeks clinical trial–related advice and which Member States are involved in the planned CTA.

The guidance explains that this information triggers the SA-CTA process and ensures the correct assessors from RMS (Reporting Member State) and MSCs (Member States Concerned) are involved from the beginning.

The process includes a unique Assessors’ Roundtable (ART), where national clinical trial experts, ETF coordinators, and ethics representatives exchange views before the consolidated advice is drafted.

4. Eligibility Criteria to Apply for SA-CTA

The guidance clearly states that the only criterion for using SA-CTA is that the clinical trial must be conducted in the EU/EEA and must fall within the ETF remit.

The guidance also notes what does not fall under SA-CTA—such as questions belonging to the SAWP/CTCG pilot or preparatory regulatory questions better handled in pre-CTA CTCG interactions.Applicants are encouraged to submit a mature clinical trial protocol or, when unavailable, a high-level protocol synopsis.

5. How to Apply for SA-CTA

The guidance explains that applications must be submitted in IRIS, using the same route as standard EMA scientific advice procedure.

To activate SA-CTA, the applicant must explicitly identify:

• The proposed Reporting Member State (RMS)

• The Member States Concerned (MSCs)

• The planned EU countries for the clinical trial

• The trial’s EUDRACT/CTIS information

• The advanced protocol or protocol synopsis

The guidance highlights that applicants do not need to prepare separate sets of questions for RMS/MSCs and ethics experts; the ETF will coordinate all assessments jointly.

6. Member State Participation

The guidance clarifies that the RMS or Lead-MS will lead the CTA-related assessment.All MSCs contribute through the Assessors’ Roundtable to ensure alignment.The guidance also describes how ethics input is provided by PHE EAG experts, who represent a collective ethics position rather than individual national ethics committees.

7. Duration and Timeline of SA-CTA

The guidance confirms that the SA-CTA follows the standard SAWP/ETF timelines, with no additional extensions required. The timeline remains consistent with normal EMA scientific advice cycles, and a process flow is included in the annex to illustrate each step from submission to the final advice letter.

8. Committees and Interactions During the Procedure

The guidance explains that the ETF already includes representatives from relevant EU regulatory, patient, and healthcare professional groups.Depending on the scientific questions, committees such as PDCO or working parties like NcWP or MWP may also be consulted on an ad-hoc basis.

9. Outcome of the SA-CTA Procedure

The outcome, as stated in the guidance, is a single consolidated scientific advice letter issued by the CHMP.This letter includes:

• Clinical trial–related regulatory perspectives

• Ethics considerations from PHE EAG

• Marketing authorisation–related advice

• Any additional Member State comments

The guidance emphasises that scientific advice is not legally binding, but applicants must justify deviations in subsequent CTA or MAA submissions.

10. Fees, Confidentiality, and Success Measures

The guidance confirms that existing EMA scientific advice fees apply; no additional fee is charged for SA-CTA. Confidentiality rules remain identical to standard CHMP scientific advice. Success is measured through applicant feedback, both immediate and long-term, to evaluate the usefulness and impact of SA-CTA on regulatory consistency and approval outcomes.

For comprehensive steps and process details, refer to the official EMA document, which provides a full breakdown of criteria, workflow, and participant roles.

Also on 21st November, 2025 the EMA has published its Regulatory Procedure Management in IRIS Roadmap (Epic 3), outlining how IRIS will evolve from 2025 to 2027. This upgraded roadmap focuses on marketing authorisations, pre-submission processes, variations, clinical data publication, ATMP certification, and fee automation.