Directives and guidelines of the European Parliament, the Council and the Commission
Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use.
Commission directive 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products.
Regulation of the European Parliament and of the Council on Clinical Trials on Medicinal Products (EU) (536/2014):
Regulation 1901/2006 of the European Parliament and of the Council on Medicinical Products for Paediatric Use:
Regulation 1902/2006 of the European Parliament and of the Council Amending Regulation 1901 on Medicinal Products for Paediatric Use:
Regulation 2016/679 of the Eruopean Parliament and of the Council on the Protection of Natural Persons With Regard to the Processing of Personal Data and on the Free Movement of Such Data: