We are independent & ad-supported. We may earn a commission for purchases made through our links.
Advertiser Disclosure
Our website is an independent, advertising-supported platform. We provide our content free of charge to our readers, and to keep it that way, we rely on revenue generated through advertisements and affiliate partnerships. This means that when you click on certain links on our site and make a purchase, we may earn a commission. Learn more.
How We Make Money
We sustain our operations through affiliate commissions and advertising. If you click on an affiliate link and make a purchase, we may receive a commission from the merchant at no additional cost to you. We also display advertisements on our website, which help generate revenue to support our work and keep our content free for readers. Our editorial team operates independently of our advertising and affiliate partnerships to ensure that our content remains unbiased and focused on providing you with the best information and recommendations based on thorough research and honest evaluations. To remain transparent, we’ve provided a list of our current affiliate partners here.
Health

Our Promise to you

Founded in 2002, our company has been a trusted resource for readers seeking informative and engaging content. Our dedication to quality remains unwavering—and will never change. We follow a strict editorial policy, ensuring that our content is authored by highly qualified professionals and edited by subject matter experts. This guarantees that everything we publish is objective, accurate, and trustworthy.

Over the years, we've refined our approach to cover a wide range of topics, providing readers with reliable and practical advice to enhance their knowledge and skills. That's why millions of readers turn to us each year. Join us in celebrating the joy of learning, guided by standards you can trust.

What is the Clinical Trial Directive?

Mary McMahon
By
Updated: May 17, 2024
Views: 5,111
Share

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.

Share
WiseGeek is dedicated to providing accurate and trustworthy information. We carefully select reputable sources and employ a rigorous fact-checking process to maintain the highest standards. To learn more about our commitment to accuracy, read our editorial process.
Mary McMahon
By Mary McMahon

Ever since she began contributing to the site several years ago, Mary has embraced the exciting challenge of being a WiseGeek researcher and writer. Mary has a liberal arts degree from Goddard College and spends her free time reading, cooking, and exploring the great outdoors.

Editors' Picks

Discussion Comments
Mary McMahon
Mary McMahon

Ever since she began contributing to the site several years ago, Mary has embraced the exciting challenge of being a...

Learn more
Share
https://www.wisegeek.net/what-is-the-clinical-trial-directive.htm
Copy this link
WiseGeek, in your inbox

Our latest articles, guides, and more, delivered daily.

WiseGeek, in your inbox

Our latest articles, guides, and more, delivered daily.