rec_13

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

(13) The assessment of the application for a clinical trial should address in particular the anticipated therapeutic and public health benefits (relevance) and the risk and inconvenience for the subject. In respect of the relevance, various aspects should be taken into account, including whether the clinical trial has been recommended or imposed by regulatory authorities in charge of the assessment of medicinal products and the authorisation of their placing on the market and whether surrogate end-points, when they are used, are justified.

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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.