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Review of CTIS transparency rules

The public consultation on the CTIS transparency rules, which was open from 3 May to 28 June 2023, is now concluded. EMA is currently reviewing the comments received, with the aim of publishing a concept paper with the proposed simplified transparency rules later this year.

date:  05/07/2023

Over 200 responses were received from CTIS users and stakeholders. The feedback reflects diverse views on the use of deferrals and redaction functionalities, although there was agreement on the need for simplification.

More information will be provided in the September issue of this newsletter.