rec_25

Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC Text with EEA relevance · European Union

(25) In order to increase transparency in the area of clinical trials, data from a clinical trial should only be submitted in support of a clinical trial application if that clinical trial has been recorded in a publicly accessible and free of charge database which is a primary or partner registry of, or a data provider to, the international clinical trials registry platform of the World Health Organization (WHO ICTRP). Data providers to the WHO ICTRP create and manage clinical trial records in a manner that is consistent with the WHO registry criteria. Specific provision should be made for data from clinical trials started before the date of application of this Regulation.

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Source: EUR-Lex (Cellar) · retrieved 2026-11-06 · Text as adopted (Official Journal); later amendments are not incorporated in this text.