1.

The reporting Member State shall assess the application with regard to the following aspects: Whether the clinical trial is a low-intervention clinical trial, where claimed by the sponsor; Compliance with Chapter V with respect to the following: The anticipated therapeutic and public health benefits taking account of all of the following: the characteristics of and knowledge about the investigational medicinal products; the relevance of the clinical trial, including whether the groups of subjects participating in the clinical trial represent the population to be treated, or if not, the explanation and justification provided in accordance with point (y) of paragraph 17 of Annex I to this Regulation; the current state of scientific knowledge; whether the clinical trial has been recommended or imposed by regulatory authorities in charge of the assessment and authorisation of the placing on the market of medicinal products; and, where applicable, any opinion formulated by the Paediatric Committee on a paediatric investigation plan in accordance with Regulation (EC) No 1901/2006 of the European Parliament and of the Council Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ L 378, 27.11.2006, p. 1). ; the reliability and robustness of the data generated in the clinical trial, taking account of statistical approaches, design of the clinical trial and methodology, including sample size and randomisation, comparator and endpoints; The risks and inconveniences for the subject, taking account of all of the following: the characteristics of and knowledge about the investigational medicinal products and the auxiliary medicinal products; the characteristics of the intervention compared to normal clinical practice; the safety measures, including provisions for risk minimisation measures, monitoring, safety reporting, and the safety plan; the risk to subject health posed by the medical condition for which the investigational medicinal product is being investigated; Compliance with the requirements concerning the manufacturing and import of investigational medicinal products and auxiliary medicinal products set out in Chapter IX; Compliance with the labelling requirements set out in Chapter X; The completeness and adequateness of the investigator's brochure.

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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.