The Accelerating Clinical Trials in the EU (ACT EU) quarterly performance reports will add a results-reporting metric, with the first expected before the end of the year. Here’s what sponsors need to know.
The EU will publish the share of trials in the Clinical Trials Information System (CTIS) that meet results-reporting requirements, with the first report expected before the end of 2026. The European Medicines Agency (EMA) has not said which parts of the compliance standard the rate will measure, or who will check the content of results documents. For multinational studies, the deadline can arrive before the global study ends.
EU regulators launched a campaign Sept. 21 aimed at trials with a missing summary of results, a missing layperson summary, or both. The EMA told Pink Sheet that these documents had been submitted for 87.2% of the trials for which results reporting was legally required. That leaves 12.8% missing one or both. Of those trials, 49% had commercial sponsors and 51% had non-commercial sponsors.
The Accelerating Clinical Trials in the EU (ACT EU) quarterly performance reports will add a results-reporting metric, with the first expected before the end of the year. In July, the European regulatory network told advocacy groups the reports would include the number of trials with available summaries of results. The EMA now describes a percentage of trials that comply with the requirements.
The EMA also said that uploading a document does not demonstrate that its content meets the requirements, and that the network will consider actions to verify completeness and quality. It has not described a method or a date.
The regulation standard is clear: Both documents must be submitted by the applicable deadline, with the content Annexes IV and V require. As reported, the 87.2% describes documents submitted. It does not say whether they were on time or whether anyone checked their content. A rate based on submission alone can only overstate compliance. The European Federation of Pharmaceutical Industries and Associations (EFPIA) has asked that compliance be assessed against a shared understanding of the regulation, and the EMA has not said which parts of the standard its rate will test.
The EMA’s July letter describes monitoring compliance and content quality as a shared responsibility of the Member States, the European Commission, and the EMA, and assigns each a role. Member States authorize and supervise trials; the Commission oversees implementation, and the EMA maintains CTIS. The EMA’s own tools as system owner are reminders, monitoring, and now a published rate.
Penalties belong to the Member States under Article 94, and they are not uniform. Citeline’s 2025 Trial and Consequence: The Global Enforcement Landscape of Clinical Trial Disclosure found fines in each European Economic Area (EEA) country that had publicly specified penalties, with amounts that varied widely. Some countries also provide criminal sanctions, license revocation, refusal to authorize new trials, or public notices.
None of the EMA statements we reviewed indicate who will check the content of results documents or when. A task shared among three bodies and assigned to none is likely to go undone. Reminders are already built into CTIS and a campaign followed in September, yet 12.8% of trials requiring results are still missing a document. CTIS has not yet published sponsor-level compliance.
Regulators in some other jurisdictions also publish noncompliance notices, and globally the most common visible form of enforcement is reputational. Refusal to authorize new trials is, in our experience, rarely announced, so the absence of announcements does not show the absence of enforcement.
Article 37(4) of the Clinical Trials Regulation (EU-CTR) sets the deadline for the summary of results at one year from the end of the trial in all Member States. The end of the trial in third countries, or countries not within the EEA, is a separate notification under Article 37(3). A multinational study can end in the EU and still be running elsewhere a year later, causing tension where results are due before the database is locked for analysis.
The regulation allows for later submission where scientific reasons are detailed in the protocol, and the protocol must then state when results will be submitted and why. That flexibility must be planned before the study starts. Where it was not, the requirement can be inherently hard to meet. The mismatch between the regulatory trigger and how multinational studies operate applies regardless of how many trials are affected.
While sponsors and investigators do provide the timeline for submitting results after global end of study to the Member States through the CTIS, this information is not published on the public portal.
Sponsors and investigators should assess their current state to prepare for questions about results compliance. Here are a few steps to take:
Clinical trial disclosure and transparency continue to be monitored by regulators, transparency advocates, and the public. Global oversight of your portfolio can help you avoid the risk of noncompliance. See how Citeline’s regulatory solutions and services can help you manage submissions, track regulations, and promote transparency.
