CTCG Guidance and Webinar: New Article 11 Workaround for Clinical Trials

The Clinical Trials Coordination Group (CTCG) has published guidance for sponsors on a new workaround for Article 11 of the Clinical Trial Regulation (Regulation (EU) No 536/2014). This approach will apply from 27 April 2026.

The new process applies to clinical trials where Part I-only submissions are planned for some Member States Concerned (MSCs). Currently, if any MSC remains Part I only, sponsors cannot submit substantial modifications or add new MSCs in CTIS.

Under the new approach, clinical trial sponsors may submit Part II placeholder documents for these MSCs as part of the initial application. This will prevent CTIS issues and enable all MSCs to be included in any future substantial modifications to the trial.

Sponsors are encouraged to include all EU/EEA MSCs where the clinical trial is planned to be conducted with the initial clinical trial application. Complete Part II documents for each member state must be submitted and authorised before the trial can start in that country.

CTCG webinar – 15 April 2026

CTCG will host a webinar for sponsors on Wednesday, 15 April 2026, at 1pm Irish time to explain how to apply this new approach. 

The webinar is open to all stakeholders involved in clinical trial submissions and will include a live Q&A session.

No registration is required and access is available through the Teams link provided in the meeting agenda. 

Further information is available on the CTCG news and events page.

Please see our clinical trials webpage for resources on complying with the CTR.