EMA: Clinical Trials Information System CTIS mandatory in 2023

As of 31 January 2023, using the new Clinical Trials Information System (CTIS) will become mandatory. CTIS serves as a single entry point of contact for the submission and assessment of clinical trial data in all EU and EEA countries. This facilitates the daily business of sponsors in the EU immensely. In the past sponsors had to submit clinical trial applications separately to competent national authorities (NCAs) and ethics committees in each European country to gain regulatory approval. Publication of the trial information is built into the system, as well.

The timeline:

• Until 30 January 2023, clinical trial sponsors can choose whether to submit an initial clinical trial application in line with the Clinical Trials Directive (EC) No. 2001/20/EC or via CTIS.
• From 31 January 2023, submission of initial clinical trial applications via CTIS becomes mandatory.
• By 31 January 2025, all ongoing trials approved under the Clinical Trials Directive No. 2001/20/EC will be governed by the new Regulation and must be transitioned to CTIS.

Revised Q&A document:

Matching the timeline, the EMA published a revised version 6.2 of the Q&A on the new clinical trial regulation, as well as descriptive material and YouTube videos on the subject.

New is

• Q&A 1.24 How are patient facing documents expected to be
  submitted?

Revised are:

• Q&A 2.6 (point 94.) Chapter X and Annex VI of the Clinical Trials
  Regulation refer to the content of the labelling of the investigational
  medicinal product (IMP). Does this mean a mock-up needs to be
  submitted?
• Q&A 3.8 (point 171.) How should a sponsor proceed when a substantial
  modification is related to a document common to various clinical trials of
  the same sponsor and same IMP?
• Chapter 11 was updated regarding the arrangements for the transitional periods and the language requirements for part I documents.

Sources:

EC: New Clinical Trial Regulation (EU) 536/2014
EMA: Clinical Trials Information System
EMA: Clinical Trials Regulation
EMA: Q&A