EMA Turns Its Pre-CTA Advice Pilot Into a Standing Service

The European Medicines Agency is converting its Pre-CTA advice pilot into a permanent service. Sponsors preparing a clinical trial application for the EU will be able to get consolidated technical and regulatory advice on the dossier before filing it in the Clinical Trials Information System as a standing offering from January 2027, rather than a time-limited pilot sponsors had to weigh against an uncertain future.

What Pre-CTA advice actually does

A clinical trial application in the EU goes through CTIS, the centralized Clinical Trials Information System, where a reporting member state and the concerned member states assess it under the Clinical Trial Regulation. The Pre-CTA pilot inserts a step before that filing: the sponsor submits the dossier to the CTCG, which coordinates feedback from the relevant national competent authorities on the technical and regulatory substance of the application before it becomes a formal, clock-starting submission. Done well, that catches problems — a missing justification, a protocol element a reporting state is likely to query — while they are still cheap to fix, rather than after a 10-day validation clock or a request for information has already started running.

Pilot to permanent: what actually changes

The practical difference for a sponsor is less about the advice itself — the pilot's mechanics carry over — and more about whether to build Pre-CTA engagement into a standard development timeline. A pilot can lapse, change scope, or simply not get renewed; a permanent service is something a regulatory affairs team can plan a program around without hedging. ACT EU will keep running applications already in its pipeline through the end of 2026 and publish a final report covering the roughly 30 applications the pilot handled since its June 2024 launch. Updated guidance documents and submission templates for the permanent service are due on the CTCG website in January 2027, when the standing service takes over from the pilot.

The pilot that did not graduate — yet

EMA launched two advice pilots together in June 2024, and only one of them is becoming permanent. The second pairs EMA's Scientific Advice Working Party (SAWP) with the CTCG to give sponsors consolidated advice spanning both the clinical trial application and the eventual marketing authorisation application — a more ambitious scope, since it asks reviewers to weigh in on development and regulatory strategy years before an approval filing. Industry feedback presented to ACT EU in March 2026 described that pilot as still being tested, with no parallel permanence decision attached. A sponsor relying on Pre-CTA advice can now treat it as routine infrastructure; a sponsor hoping for the broader consolidated scientific-and-regulatory advice track should keep treating it as provisional until EMA says otherwise.

Why it sits inside ACT EU

Both pilots run under Accelerating Clinical Trials in the EU (ACT EU), the joint EMA/European Commission/Heads of Medicines Agencies initiative launched to speed up and simplify EU clinical trials following the bloc's move to the unified Clinical Trial Regulation and CTIS. The ACT EU Steering Group holds decision-making authority over which pilots graduate, continue, or wind down, reporting to the EMA Management Board and the Heads of Medicines Agencies — the body that made this permanence call.

Frequently asked questions

What is becoming permanent, and when?

The Pre-CTA pilot — consolidated technical and regulatory advice on a clinical trial application dossier before its submission in CTIS. EMA announced around 9 October 2026 that it becomes a standing service from January 2027, coordinated by the CTCG.

Does this cover scientific advice on the eventual marketing authorisation too?

No. The companion SAWP-CTCG pilot, which launched alongside Pre-CTA in June 2024 to cover both clinical trial and marketing authorisation advice, remains under evaluation and has not been made permanent.

What happens to pilot applications already in progress?

ACT EU continues administering applications already submitted through the end of 2026, including a final report covering roughly 30 applications. Updated guidance and templates for the permanent service are due on the CTCG website in January 2027.

Who decided this?

The ACT EU Steering Group, which holds decision-making authority over the initiative and reports to the EMA Management Board and the Heads of Medicines Agencies.