CTAG Meeting Minutes: Optimizing Multinational Clinical Trial Processes

In the recent ad-hoc meeting of the Clinical Trial Coordination and Advisory Group (CTAG) on March 15, 2024, the focus was on enhancing the submission process for Substantial Modification and Additional Member States Concerned applications.

During the meeting, the CTAG reached agreements aimed at expediting multinational clinical trial submissions:

• Part II Substantial Modification Application: Sponsors now have the option to promptly submit Part II applications upon trial authorization in a Member State, eliminating the need for ongoing assessments.
• Additional MSC Application: Sponsors can submit additional MSC applications after initial authorization by one of the initial Member States Concerned (MSC) for the clinical trial.
• Outstanding Part II Documents Submission: Sponsors are allowed to provide outstanding Part II documents in Member State A (Art. 11), while Member States B and C handle other applications, provided there are no ongoing assessments in Member State A.

In addition, CTAG members emphasized the importance of submitting complete and high-quality dossier applications (both part I and II simultaneously) in all intended Member States for the clinical trial. While Article 11 of the CTR allows sponsors to initially submit only Part I of the application, a comprehensive approach ensures smoother processes and regulatory compliance.

In my opinion, these clarifications are instrumental as they make decisions clear how to approach the different scenarios and enhance the start of the Clinical Trial in the single MSCs of a Clinical Trial.

For the full Meeting Minutes please refer to: https://ec.europa.eu/transparency/expert-groups-register/core/api/front/document/104269/download

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