1. 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;European Parliament, Council of the European Union;Offic J Eur Union,2001
2. Regulation (EU) 536/2014 on of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC;European Parliament, Council of the European Union;Offic J Eur Union,2014
3. Petrini C . What is the role of ethics committees after Regulation (EU) 536/2014? J Med Ethics. Westra AE, Ambiguous articles in new EU Regulation may lead to exploitation of vulnerable research subjects. J Med Ethics.
4. Clinical trials abroad: the marketable ethics, weak protections and vulnerable subjects of EU law;Flear,2014