Ethic and Legal Issues

In this section you will find relevant documents to guide you on ethical and legal issues in the RD field

  1. Showing 96 results for:
  2. Regulatory Science
  3. Ethic and Legal Issues
All Subjects

European Medicines Agency. Committee for Medicinal Products for Human Use (CHMP). ICH S5 (R3) Guideline on Reproductive Toxicology: Detection of Toxicity to Reproduction for Human Pharmaceuticals. Step 5. 17 February 2020. EMA/CHMP/ICH/544278/1998

Published by European Medicines Agency (EMA)

Animal ModelsClinical TrialsEMAGuidelinePharmaceuticals ToxicityVaccine

This guideline applies to all pharmaceuticals, including biopharmaceuticals, vaccines (and their novel constitutive ingredients) for infectious diseases, and novel excipients that are part of the final pharmaceutical product. 

View this resource Bookmark this resource

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.

View this resource Bookmark this resource

Commission Notice Guideline on the format and content of applications for designation as orphan medicinal products and on the transfer of designations from one sponsor to another 2022/C 440/02

Published by European Commission (EC)

Guideline on the format and content of applications for designation as orphan medicinal products and on the transfer of designations from one sponsor to another

Bookmark this resource

COMMISSION DIRECTIVE 2006/86/EC of 24 October 2006 implementing Directive 2004/23/EC of the European Parliament and of the Council as regards traceability requirements, notification of serious adverse reactions and events and certain technical requirements for the coding, processing, preservation, storage and distribution of human tissues and cells

Published by European Commission (EC)

human cellshuman tissues

EC Directive on traceability requirements, notification of serious adverse reactions and events and certain technical requirements for the coding, processing, preservation, storage and distribution of human tissues and cells.

View this resource Bookmark this resource

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

View this resource Bookmark this resource