Regulatory Focus™ > News Articles > EMA Prepares to Free up Clinical Trials Results Starting Next Month

EMA Prepares to Free up Clinical Trials Results Starting Next Month

Posted 20 June 2014 | By Alexander Gaffney, RAC

EMA Prepares to Free up Clinical Trials Results Starting Next Month

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 even broader policy of clinical trials transparency, which is expected to come into effect in October 2014.

 

EMA Statement

EMA Guidance on EudraCT

Categories: Regulatory News

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