One Step Away: European Parliament Approves New Clinical Trials Regulation

by Ropes & Gray LLP
Contact

On April 2, 2014, the European Parliament approved the new clinical trials regulation (the “Regulation”) for the European Union (“EU”), with 594 votes in favor, 17 opposed and 13 abstentions. The European Parliament approved the Regulation in substantially the same form as the proposed draft regulation endorsed by the Committee of Permanent Representatives of the European Union on December 20, 2013. 

For it to become law across the EU, the Regulation needs to be adopted formally by the European Council of Ministers. That is expected to occur on April 14, 2014. Significant changes are not anticipated at this final stage of the process. After formal approval by the European Council of Ministers, the Regulation is expected to be signed into law on April 16, 2014. Following the signing, the Regulation will be published in the Official Journal of the European Union Publication, which is expected to happen at the end of June. This Regulation will replace the existing clinical trials Directive 2001/20EC, and will be binding in its entirety and automatically incorporated into the national laws for all EU Member States.

Notably, the Regulation establishes a new streamlined application and review process for research sponsors wishing to site clinical trials in the EU, including a web-based portal for submission of all clinical trials applications (the “EU Portal”). Additionally, the Regulation increases transparency of data collected from clinical trials performed in the EU. The Regulation requires sponsors who have been approved to hold clinical trials within the EU to post detailed summaries of clinical trial data, including a plain-language summary, within one year of the termination of the clinical trial (e.g., last visit by the last subject or as otherwise defined in the protocol). All summaries will be centralized on a publicly accessible, free and searchable database of all approved clinical trial data relating to medicinal products. On the same database, within 30 days of the marketing application’s authorization, rejection or withdrawal, sponsors will be required to post full clinical study reports that were submitted to EMA in support of the marketing application. Failure to post the summaries or final clinical study reports will result in fines. For a summary on the other notable provisions of the Regulation, see our January alert.

The Regulation will not be enforced until six months after the EU Portal is fully functional. While the EU Portal is currently being developed by the European Medicines Agency, no deadline has been set. In light of that process, the Regulation is not expected to become effective until sometime in mid-2016, at the earliest.

The European Parliament stated its hope that the new Regulation will “streamline the rules on clinical trials across Europe, facilitating cross-border cooperation to enable larger, more reliable trials,” and that “[b]y working at EU level we can reduce the huge cost and burden of conducting trials across borders.” The EU Health Commissioner, Tonia Borg, announced that, in the aggregate, the Regulation would save research sponsors with clinical trials in the EU approximately $1.1 billion dollars in regulatory costs annually.
 

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

© Ropes & Gray LLP | Attorney Advertising

Written by:

Ropes & Gray LLP
Contact
more
less

Ropes & Gray LLP on:

Readers' Choice 2017
Reporters on Deadline

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up using*

Already signed up? Log in here

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
Privacy Policy (Updated: October 8, 2015):
hide

JD Supra provides users with access to its legal industry publishing services (the "Service") through its website (the "Website") as well as through other sources. Our policies with regard to data collection and use of personal information of users of the Service, regardless of the manner in which users access the Service, and visitors to the Website are set forth in this statement ("Policy"). By using the Service, you signify your acceptance of this Policy.

Information Collection and Use by JD Supra

JD Supra collects users' names, companies, titles, e-mail address and industry. JD Supra also tracks the pages that users visit, logs IP addresses and aggregates non-personally identifiable user data and browser type. This data is gathered using cookies and other technologies.

The information and data collected is used to authenticate users and to send notifications relating to the Service, including email alerts to which users have subscribed; to manage the Service and Website, to improve the Service and to customize the user's experience. This information is also provided to the authors of the content to give them insight into their readership and help them to improve their content, so that it is most useful for our users.

JD Supra does not sell, rent or otherwise provide your details to third parties, other than to the authors of the content on JD Supra.

If you prefer not to enable cookies, you may change your browser settings to disable cookies; however, please note that rejecting cookies while visiting the Website may result in certain parts of the Website not operating correctly or as efficiently as if cookies were allowed.

Email Choice/Opt-out

Users who opt in to receive emails may choose to no longer receive e-mail updates and newsletters by selecting the "opt-out of future email" option in the email they receive from JD Supra or in their JD Supra account management screen.

Security

JD Supra takes reasonable precautions to insure that user information is kept private. We restrict access to user information to those individuals who reasonably need access to perform their job functions, such as our third party email service, customer service personnel and technical staff. However, please note that no method of transmitting or storing data is completely secure and we cannot guarantee the security of user information. Unauthorized entry or use, hardware or software failure, and other factors may compromise the security of user information at any time.

If you have reason to believe that your interaction with us is no longer secure, you must immediately notify us of the problem by contacting us at info@jdsupra.com. In the unlikely event that we believe that the security of your user information in our possession or control may have been compromised, we may seek to notify you of that development and, if so, will endeavor to do so as promptly as practicable under the circumstances.

Sharing and Disclosure of Information JD Supra Collects

Except as otherwise described in this privacy statement, JD Supra will not disclose personal information to any third party unless we believe that disclosure is necessary to: (1) comply with applicable laws; (2) respond to governmental inquiries or requests; (3) comply with valid legal process; (4) protect the rights, privacy, safety or property of JD Supra, users of the Service, Website visitors or the public; (5) permit us to pursue available remedies or limit the damages that we may sustain; and (6) enforce our Terms & Conditions of Use.

In the event there is a change in the corporate structure of JD Supra such as, but not limited to, merger, consolidation, sale, liquidation or transfer of substantial assets, JD Supra may, in its sole discretion, transfer, sell or assign information collected on and through the Service to one or more affiliated or unaffiliated third parties.

Links to Other Websites

This Website and the Service may contain links to other websites. The operator of such other websites may collect information about you, including through cookies or other technologies. If you are using the Service through the Website and link to another site, you will leave the Website and this Policy will not apply to your use of and activity on those other sites. We encourage you to read the legal notices posted on those sites, including their privacy policies. We shall have no responsibility or liability for your visitation to, and the data collection and use practices of, such other sites. This Policy applies solely to the information collected in connection with your use of this Website and does not apply to any practices conducted offline or in connection with any other websites.

Changes in Our Privacy Policy

We reserve the right to change this Policy at any time. Please refer to the date at the top of this page to determine when this Policy was last revised. Any changes to our privacy policy will become effective upon posting of the revised policy on the Website. By continuing to use the Service or Website following such changes, you will be deemed to have agreed to such changes. If you do not agree with the terms of this Policy, as it may be amended from time to time, in whole or part, please do not continue using the Service or the Website.

Contacting JD Supra

If you have any questions about this privacy statement, the practices of this site, your dealings with this Web site, or if you would like to change any of the information you have provided to us, please contact us at: info@jdsupra.com.

- hide
*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.