Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at raps@raps.org if you need assistance.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
The highly-anticipated fifth edition is here! Get the must-have resource for achieving compliance with medical device regulations.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
In less than a month, pharmaceutical companies operating in the EU will need to begin posting clinical trial results in the European Clinical Trials Database (EudraCT) under a new plan meant to expand the amount of information available to consumers.
Background
The plan was first announced by the European Medicines Agency (EMA) in October 2013, when it said that an update to EudraCT, dubbed EudraCT V9, would enable pharmaceutical companies to post new types of information to the database.
The end goal of the system, EMA said, was to move beyond having just basic trial protocol information in the registry, toward a system capable of providing public access to the results of trials, including those with negative results.
EMA opened the system last year to companies, saying they could voluntarily begin uploading the results of their trials to the system immediately. However, it was only slated to become mandatory in "mid-2014," regulators said at the time.
EudraCT V9 Launch
In an announcement on 19 June 2014, EMA regulators said the system is now ready and its launch date is fast approaching.
The new system will become mandatory as of 21 July 2014, EMA said.
EMA explained:
"This date corresponds to the finalisation of the programming of the database as referred to in a European Commission guideline, in application of the current clinical trials Directive 2001/20/EC and the Paediatric Regulation. Under these frameworks, since the result-related information is fed into the publicly accessible European Union Clinical Trials Register, summary results of clinical trials will become available to the public as sponsors start to comply with their legal obligations."
Requirements
Henceforth, EMA said, all interventional trials ending after 21 July 2014 will need to have their results entered into the EudraCT database within six months (or 12 months for some types of trials).
For trials ending prior to 21 July 2014 (but after 21 July 2013), EMA said sponsors will need to submit the results of those trials within one year. Sponsors have two years to post the results of all trials data for trials which concluded prior to 21 July 2013.
The database will also include information on pediatric trials. That data formerly resided on EMA's website, and not EudraCT's website.
The change comes just days after EMA committed to an
EMA Statement
Tags: EudraCT, Clinical Trials Transparency, Clinical Data Transparency, Clinical Trials Reporting