CTR / CTIS Guidance Update

Monoclonal Antibodies - From Concept to Approval

Recommendation

20/21 May 2025
Vienna, Austria

Monoclonal Antibodies - From Concept to Approval
With a workshop about the development of ADCs

The EMA and the HMA published the following revised guidance documents relating to the CTIS transparency rules and the transition of clinical trials.

CTIS Transparency Rules

The questions and answers on the protection of commercially confidential information (CCI) and personal data in CTIS have been updated, and a quick guide for users has also been published on the ACT-EU website. The Q&As intend to provide more clarity on main aspects that have been discussed with the Clinical Trials Coordination Group (CTCG), and it should be read in conjunction with the Guidance document on how to approach protection of personal data and CCI while using the CTIS. The Q&A document (version 1.3) now includes a new section on the interim period until the technical implementation of the revised CTIS transparency rules on the CTIS public website and on historical trials (all studies submitted up to that date). The quick guide summarizes what will be published under the revised rules, the relevant publication dates and the new Q&A section mentioned above.

Transition of Studies to the CTR

The CTCG has published revised versions of the best practice guide (Vs.3) and the cover letter template for sponsors transitioning multinational clinical trials to the Clinical Trials Regulation (CTR) and CTIS. The revised guide clarifies the concept of consolidated protocols by providing an example illustrating the transition of a Clinical Trials Directive (CTD) trial to the CTR with different protocol versions approved in the Member States Concerned (MSC).

In addition, the document includes clarifications on background treatment and the status of non–Investigational Medicinal Products (non-IMPs) under the CTD regarded as IMP or AxMP under the CTR. Changes in vs. 2 compared to the earlier version already affected the Consolidated Investigator’s brochure (IB) and/or Investigational Medicinal Product Dossier (IMPD) not previously harmonized under the CTD.

More information is available at the CLINICAL TRIALS COORDINATION GROUP (CTCG) website.