Bach Karin Friis, Jørgensen Annette
Sektion for Samfundsfarmaci og Klinisk Farmaci, Det Sundhedsvidenskabelige Fakultet, Københavns Universitet, Universitetsparken 2, 2100 København Ø.
Ugeskr Laeger. 2013 Nov 11;175(46):2778-81.
A proposal for a new regulation on clinical trials that will replace the Clinical Trials Directive has been launched by the EU Commission the 17 July 2012. The proposal contains ideas that undoubtedly will lead to a greater harmonisation within the EU, a more smooth approval procedure, and a lowering of the administrative burden. Details are still to be discussed, and waiting until 2016 when the new rules are adopted is definitely a problem, but all together the new proposal is to be regarded as good news for clinical drug research.
欧盟委员会于2012年7月17日提出了一项关于临床试验的新法规提案，该提案将取代《临床试验指令》。该提案中的想法无疑将使欧盟内部实现更大程度的协调统一、审批程序更加顺畅，并减轻行政负担。细节仍有待讨论，而且要等到2016年新规则通过显然是个问题，但总体而言，这项新提案对临床药物研究来说是个好消息。
