Clinical Trials Directive Explained

The Clinical Trials Directive (Officially Directive 2001/20/EC of 4 April 2001, of the European Parliament and of the Council on the approximation of the laws, regulations and administrative provisions of the Member States relating to implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use) is a European Union directive that aimed at facilitating the internal market in medicinal products within the European Union, while at the same time maintaining an appropriate level of protection for public health. It seeks to simplify and harmonise the administrative provisions governing clinical trials in the European Community, by establishing a clear, transparent procedure.

The Member States of the European Union had to adopt and publish before 1 May 2003 the laws, regulations and administrative provisions necessary to comply with this Directive. The Member States had to apply these provisions at the latest with effect from 1 May 2004.

The Articles of the Directive

The Articles of the Directive:

The effects of the directive

It increased the costs of doing clinical trials in the EU, and a reduction in the number of such trials followed its implementation,[1] especially of academic-led studies, and ones looking at new uses for old drugs.[2] Germany derogated from the directive.[2] It is due to be replaced by the EU Clinical Trials Regulation in 2016.[1] The changes are due to come into effect in the second half of 2019.[3]

See also

References

Notes and References

  1. http://vertassets.blob.core.windows.net/download/a78320af/a78320af-1b65-4bbe-b603-bb0540285015/synhcr_eu_ct_regulation.pdf The New EU Clinical Trials Regulation: The Good, the Bad, the Ugly
  2. News: We can now revive clinical trials killed by the EU . 8 October 2016 . A Dalgleish . The Daily Telegraph . London . 21 . print and online
  3. Web site: European Medicines Agency - Clinical trials - Clinical Trial Regulation . https://web.archive.org/web/20180315003521/http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000629.jsp&mid=WC0b01ac05808768df . 2018-03-15 . ema.europa.eu.