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Formal adoption of European clinical trial data publication policy to be delayed, EMA says

Out-Law News | 11 Jul 2014 | 5:08 pm | 1 min. read

Proposals which would allow the download, saving and printing of clinical trial data submitted as part of EU marketing authorisation applications will not be formally adopted until October to allow for "clarifications on wording and practical arrangements", according to the European Medicines Authority (EMA).

In a statement, the EMA's management board said that members had confirmed "general support" for the overall aims and objectives of the new policy, including amendments made by the EMA's executive director, Guido Rasi. Rasi's amendments followed concerns raised by the European Ombudsman that the EMA's draft policy only allowed clinical data to be seen on screen, making it more difficult for researchers to use.

The announcement will mean a delay to the introduction of the new policy, which was due to begin on 1 October 2014. Final agreement on and adoption of the policy is expected at the next meeting of the EMA's management board, which takes place on 2 October, according to the statement.

"The Agency welcomes this additional round of joint reflections and respects all opinions, as well as the views expressed by several member states, which largely reproduce the complexity of the debate on both political and technical aspects which have emerged during the previous general and more targeted consultation phases," the board said in its statement. "In the last 12 months the Agency has attempted to strike a balance between proactive data disclosure, the absolute need to protect personal data and the concerns relating to the protection of commercially confidential information."

"The Agency management remains committed to introducing this additional measure towards transparency as soon as possible, so as to enhance citizens' awareness and confidence in the EU authorisation system for medicinal products ... The Agency management is conscious that any delay prevents citizens, and in particular academics and non-commercial researchers, from enjoying the benefits of proactive publication of clinical trial data for a further period," it said.

The EMA's policy on clinical trials data is part of wider measures across the EU to address issues surrounding clinical trials. A new EU Clinical Trials Regulation is due to come into force on 28 Mat 2016, replacing the existing EU Clinical Trials Directive, and is intended to streamline the authorisation process and harmonise requirements for clinical trials in Europe.

The new system will harmonise rules across all 28 EU countries, in contrast to the current situation where each state has its own set of rules to implement the existing directive. Applicants will be able to submit a single application for a clinical trial via a single EU portal.