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EMA released a draft policy on the publication and access to clinical-trial data for consultation

The European Medicines Agency (EMA), has released for public consultation, a draft policy on the publication and access to clinical trial data.

The draft policy aims to take into account the different views and concerns brought forward by a broad range of stakeholders and European bodies, balancing out the commitment to give widest possible access to data for independent scrutiny with the need to protect personal data as well as legitimate commercially confidential information. It includes three categories of clinical-trial data corresponding to different levels of access:

  1.     Commercially confidential information: clinical-trial data, information or documents that may contain commercially confidential information (e.g., details of the investigational medicinal product itself, some in-vitro studies or bioanalytical data characterising the product).
  2.     Open access: any clinical-trial data, information or documents that do not contain patients’ personal data. This information will be downloadable from the EMA’s website, at the time of publication of the European public assessment report (EPAR) for positive decisions, negative decisions, or withdrawals.
  3.     Controlled access: clinical-trial data, information or documents containing patients’ personal data. This data will need to be adequately de-identified according to a recommended minimum standard. Access to these data will only be granted after the requester has fulfilled a number of requirements, including the signing of a data-sharing agreement.

Next steps                        

  •     By end 2013: Expected publication of the final policy.
  •     1 January 2014: The EMA expects the policy to come into force. It can depend on the Court decision and the discussions on the Regulation on Clinical Trials.

Comments must be sent not later than 30 September to [email protected] The Draft policy on the publication and access to clinical-trial data is available here.


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