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