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EU nations approve law to overhaul clinical trials

BMJ 2013; 347 doi: http://dx.doi.org/10.1136/bmj.f7682 (Published 23 December 2013) Cite this as: BMJ 2013;347:f7682
  1. Rory Watson
  1. 1Brussels

European Union governments have given their support to pan-European legislation that would speed up authorisation procedures for clinical trials and ensure that all trials were registered in a central database and their results made publicly available.

The new measures, which had been politically agreed by governments and the European Parliament in the second week of December, will replace rules that have operated since 2001 with simpler, more uniform requirements. The current rules have been widely criticised for being excessively bureaucratic, leading to a sharp decline in the European Union in trials of drugs for humans. In 2007 the number of …

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