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

Medicinal ProductsClinical Trialinvestigational medicinal 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

Regulation (EC) 1901/2006 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.OJL 378/1, 27.12.2006, as amended by REGULATION (EC) No 1902/2006.

Published by European Parliament and of the Council of the European Union

Medicinal ProductsPaediatric Use 

This Regulation lays down rules concerning the development of medicinal products for human use in order to meet the specific therapeutic needs of the paediatric population, without subjecting the paediatric population to unnecessary clinical or other trials and in compliance with Directive 2001/20/EC.

View this resource Bookmark this resource

F74European Parliament and Council of the European Union. 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 726/2004.

Published by European Commission (EC)

Medicinal ProductsAdvanced Therapy Regulation

This regulation addresses issues related to the definition and  the development of advanced therapies, such as gene therapy, somatic cell therapy, and tissue engineering

View this resource Bookmark this resource

Commission of the European Communities. COMMISSION DIRECTIVE 2009/120/EC of 14 September 2009 amending Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use as regards advanced therapy medicinal products.

Published by European Commission (EC)

Medicinal ProductsAdvanced Therapy Regulation

This Directive addresses the definitions and detailed scientific and technical requirements for gene therapy medicinal products and somatic cell therapy medicinal products should be updated

View this resource Bookmark this resource