Don't wait for the rejection letter: make pre-submission advice a standard step in every EU trial

A pilot that is about to become infrastructure

The Slovak regulator ŠÚKL has confirmed that the ACT EU pre-submission advice pilot for clinical trials will continue as a permanent initiative from January 2027. It is an EU-level advisory scheme for sponsors who are preparing clinical trial applications. A final report covering about 30 applications is due by the end of 2026.

That is not much to go on. We do not yet know what the report will say, and the information available does not describe how the advice works in practice, what it costs sponsors in time, or whether it changes outcomes. But the decision to make the scheme permanent before the final report is published is itself a signal. The organisers appear to have seen enough to commit.

My position is simple. Sponsors running trials in the EU should stop treating regulatory advice as a rescue tool for troubled dossiers. They should build it into the standard development path, and they should do so before the permanent scheme opens.

Why early advice belongs in the plan

The cost of a weak application is paid late. A clinical trial application raises questions about design, documentation and readiness, and answering them after submission means clock time, amended documents and delayed first-patient-in. Advice that surfaces the same questions before submission moves that work to the cheapest point in the process.

The records offer a useful contrast. In the US, Processa Pharmaceuticals announced FDA clearance of an IND for a Phase 2 study of its oral BTK inhibitor VT-7208 in urticaria. The announcement says nothing about how Processa prepared its filing, and I will not guess. But the US system has long normalised the idea that sponsors talk to the agency before they file. The EU's multi-country clinical trial environment has been harder to navigate. A permanent, EU-level advice channel is a chance to close that gap.

The strongest counter-argument

The best objection is that we are being asked to act on thin evidence. About 30 applications is a small sample, and the final report is not out. Advice also takes time to request and absorb. For a small sponsor with a tight runway, another step before submission can feel like a cost with an uncertain return. And pre-submission advice is no guarantee of authorisation: nothing in the records suggests that following it removes the need for a full assessment.

That objection is fair, and it is a reason to read the final report carefully. It is not a reason to wait. The downside of requesting advice is a modest planning overhead. The downside of ignoring it is learning about a design or documentation problem from a formal assessment, when it is more expensive to fix. Sponsors who build the habit now will be better placed to judge, from their own experience, whether the scheme earns its place.

What a sensible sponsor does next

Treat January 2027 as a planning date. Any EU application you expect to file in 2027 should have an advice decision on the timeline: use it or not, and if not, a documented reason. Decide which questions are worth asking, for example novel design elements or points where national and EU expectations may diverge. Assign someone to bring back the advice and trace each point to a protocol or dossier change.

Then watch for the end-2026 report. Until it appears, we do not know which kinds of application benefited most. Sponsors should not claim more for the scheme than the evidence supports, and regulators should publish enough detail for sponsors to judge for themselves.