Implementation of Clinical Trials Regulation discussed at the meeting in Riga

Implementation of Clinical Trials Regulation discussed at the meeting in Riga

On 16-17 June 2015 the meeting of the Heads of Medicines Agencies (HMA) Clinical Trials Facilitation Group (CTFG) took place in Riga. The main focus was on the implementation of the Regulation (EU) No 536/2004 of the European Parliament and of the Council on Clinical Trials on Medicinal Products for Human Use which came into force in June 2014 and will be applied no sooner than 28 May 2016.

Clinical research is a very important and mandatory step in the process of developing new medicines. It is necessary to obtain data regarding the effectiveness and safety of these medicines. A harmonised approach ensures unified principles in the evaluation of applications for clinical trials throughout Europe and a competent benefit/risk assessment. Read more