Implementation of Clinical Trials Regulation discussed at the meeting in RigaOn 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. In comparison to the Directive 2001/20/EC currently in effect, the Regulation will ensure that there will be a lot more publicly available information regarding clinical trials, this will include an obligation for sponsors to publish all clinical trial results. The results will be published even if they are not positive. The Regulation also stipulates that all clinical trial applications will be submitted into one single Portal, which will be a new European Clinical Trial Database, thus, ensuring the availability of information for all residents. Meeting participants (clinical trial experts from national medicines agencies in Europe and from the European Medicines Agency) also discussed the following topics related to the Regulation:
The Heads of Medicines Agencies (HMA) agreed in 2004 to establish the Clinical Trials Facilitation Group (CTFG) to coordinate the implementation of the European Clinical Trials Directive 2001/20 EC across the Member States. Future CTFG activities are related to the establishment of unified principles and procedures for the evaluation and authorisation of clinical trials throughout Europe. Additional information regarding the Clinical Trials Facilitation Group is available on HMA website.
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Implementation of Clinical Trials Regulation discussed at the meeting in Riga
19.06.2015.