27.5.2014 Official Journal of the European Union L 158/1 (Legislative acts) REGULATIONS REGULATION (EU) No 536/2014 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 (Text with EEA relevance) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Articles 114 and 168(4)(c) thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Economic and Social Committee (}), After consulting the Committee of the Regions, Acting in accordance with the ordinary legislative procedure (), Whereas: (1)  In a clinical trial the rights, safety, dignity and well-being of subjects should be protected and the data generated should be reliable and robust. The interests of the subjects should always take priority over all other interests. (2)  In order to allow for independent control as to whether these principles are adhered to, a clinical trial should be subject to prior authorisation. (3)  The existing definition of a clinical trial as contained in Directive 2001/20/EC of the European Parliament and of the Council (*) should be clarified. For that purpose, the concept of clinical trial should be more precisely defined by introducing the broader concept of ‘clinical study’ of which the clinical trial is a category. That category should be defined on the basis of specific criteria. This approach takes due account of international guidelines, and is in line with the Union law governing medicinal products, which builds on the dichotomy of ‘clinical trial’ and ‘non-interventional study’. (4)  Directive 2001/20/EC aims to simplify and harmonise the administrative provisions governing clinical trials in the Union. However, experience shows that a harmonised approach to the regulation of clinical trials has only been partly achieved. This makes it in particular difficult to perform a given clinical trial in several Member (i) OJ C44,15.2.2013,p. 99. (}) Position of the European Parliament of 3 April 2014 (not yet published in the Official Journal) and decision of the Council of 14 April 2014. () 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 (O] L 121, 1.5.2001, p. 34).