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Ethical considerations for clinical trials on medicinal products conducted with minors. Recommendations of the expert group on clinical trials for the implementation of 12 Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use (2017).

Published by EC

AdolescentAssent Clinical TrialsConsentEthics CommitteeMinorNeonate

The document provides recommendations on various ethical aspects of clinical trials performed in children from birth up to the legal age of adulthood.

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Commission Implementing Regulation (EU) 2022/20 of 7 January 2022 laying down rules for the application of Regulation (EU) No 536/2014 of the European Parliament and of the Council as regards setting up the rules and procedures for the cooperation of the Member States in safety assessment of clinical trials (Text with EEA relevance)

Published by EC

Clinical Trialinvestigational medicinal productsMedicinal Products

EU Regulation setting up the rules and procedures for the cooperation of the Member States in safety assessment of clinical trials

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REGULATION (EC) No 1394/2007 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2003

Published by EC

Advanced TherapyMarketing Authorisation

This Regulation lays down specific rules concerning the authorisation, supervision and pharmacovigilance of advanced therapy medicinal products.

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The Need for Non-Human Primates in Biomedical Research, Production and Testing of Products and Devices (Update 2017)

Published by EC

Non-Human Primate Model

EU opinon and legilastion on the suse of Non-human Primate in Biomedical Research. The European Commission strongly advocates the “3Rs principle”. now a legal obligation embedded in the EU legislation to: Replace non-human primates with viable alternatives whenever feasible, Reduce the use of non-human primates and Refine scientific procedures and the care and treatment of the animals

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