Last update:
15-Jan-2020

Since the 1980s, attention has been addressed in the European Union (EU) to harmonization of the legislative and regulatory framework in the member states, to facilitate the conduct of clinical trials and reduce their cost. Currently, the EU Commission and Parliament have already approved new legislation, which is pending adoption by the member states and which has already been the subject of extensive reflection and discussion. This review investigates the new EU Regulation no 536/2014 (thereafter referred to as "Regulation") for clinical trials. A systematic literature review produced 39 articles that met the inclusion and exclusion criteria. Optimistic expectations regarding the objectives of the Regulation to facilitate the conduct of clinical trials were expressed by 74% of the articles; 38% of the articles pointed out potential issues relating to reduced security of patients' rights and the importance of ethics committees, while 38% mentioned potential concerns for some of the member states which may not be sufficiently prepared for implementation of the Regulation. The greatest benefit of the Regulation will be the promotion of research and development in the EU, as its main goals are directed towards full harmonization of the European legislation for clinical trials, simplification and improvement of the regulatory framework and the enhancement of transparency of exported data.

Key words: Clinical trials, 2001/20/EU, (EU) no 536/2014, European Regulation.