What is the Clinical Trial Directive?

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  • Written By: Mary McMahon
  • Edited By: Kristen Osborne
  • Last Modified Date: 05 October 2019
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The Clinical Trial Directive is an act of legislation passed by the European Parliament to regulate the practice of clinical trials in the European Union. Known officially as Directive 2001/20/EC and approved in April 2001, this document creates a framework for regional regulation of clinical trials within the European Union. This was designed to streamline the process while providing appropriate protections for consumers and participants in clinical trials. Like other EU legislation, it creates guidelines for member nations to follow when developing their own laws and policies, with the goal of providing harmonized legal requirements.

There are several sections to the Clinical Trial Directive, defining clinical trials, providing specific safety guidelines, particularly for minors and people with diminished mental capacity, and drafting rules for obtaining approval for clinical trials. People who want to test medications and medical devices in the European Union need ethics board approval for their projects and must provide a detailed application discussing the nature of the trial and the protections being put in place to protect participants.


The directive is very concerned with protecting public health, addressing ethical issues concerning clinical trials, and making sure that trials are safe. Some critics argued that the Clinical Trial Directive limited the scope of medical testing in the European Union, making it harder for companies to innovate. Others felt it streamlined the process by creating a uniform regulatory framework for individual member nations to adopt, making it easier for companies to get clinical trial approval as long as they followed the guidelines in this directive.

Under the Clinical Trial Directive, companies are required to meet certain parameters when they perform clinical trials. Individual member nations can set specific standards for approval of clinical trials and may require additional regulatory steps, depending on their policies. The trial design must demonstrate that the safety needs of participants have been considered as a priority, while showing the function of the trial; if a company cannot show what, exactly, it is aiming to test, the trial will not be cleared.

Companies planning to seek approval for medications in multiple nations may need to conduct different clinical trials to meet the standards set out by regulatory agencies. Many companies have a legal department specializing in clinical trial process. If they don't, they may consult outside counsel in order to ensure clinical trials are performed as efficiently as possible, avoiding pitfalls like failing to comply with regulations like the Clinical Trial Directive and having to start again or redesign a study.


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