March 2026
Disclosure Roundup

The ANZCTR has introduced a dedicated submission pathway allowing investigators in Australia and New Zealand to add or update local details, such as sponsor, investigator, funder, ethics approval, and data-sharing plan, for trials registered on ClinicalTrials.gov. This does not create a new registration or affect the source record. Submissions undergo a brief staff review before publication.

The MHLW has updated the jRCT registration process for notifications other than regenerative medicine. Sponsors and investigators can now obtain a jRCT number via "provisional registration" before submitting an implementation plan. Information entered at the provisional registration stage will not be publicly visible on jRCT. Regenerative medicine notifications remain unchanged.

The HMA confirmed process refinements to the FAST-EU pilot, including fixed expression of interest windows and a single fixed CTIS submission date to support ethics committee planning. Combined clinical trial and IVD performance study or Medical Device clinical investigation applications are excluded from the pilot, as several Member States cannot assess the IVD/MD component within the required timelines.

The TCTR has advised that studies with an 'Unknown' status will not be imported by the WHO into the ICTRP database, rendering them unsearchable via the WHO platform. Registrants are strongly advised to update their project status before submitting work for publication, as failure to do so may cause issues with medical journal requirements.

The FAMHP has launched a publicly accessible clinical trial dashboard, providing quarterly statistics on all initial CTR submissions decided in Belgium since the CTR entered into force. The dashboard covers trial volumes by phase and therapeutic area, as well as median turnaround times. In 2025, the median turnaround for mononational Phase I trials was 41 days. The dashboard does not impose new obligations on sponsors.

The EMA published version 1.0 of the CTIS Sponsor FAQ, consolidating and superseding two prior Q&A documents on CTIS and CCI/personal data protection. The document addresses operational processes across the trial lifecycle, including application management, disclosure obligations, results submission, and RFI procedures. It complements the Sponsor Handbook as authoritative procedural guidance for sponsors.

The EMA published version 6.2 of the CTIS Sponsor Handbook with operational clarifications. Section 4.3.2 and 4.8.2 specify that sponsors must use the 'update' icon (not 'Add document') when revising existing documents within SM and NSM applications. References to the newly published Sponsor FAQs have been added throughout to supplement procedural guidance.

The European Commission has published version 7.2 of the CTR Q&A, providing operational clarifications on interim results submission mechanics, timelines, and non-publication rules in CTIS (Q&A 6.7); parallel Article 14 submissions (Q&A 2.12); the Article 11 MSC workaround (Q&A 3.6); and language requirements for Croatia and Bulgaria in Annex II.