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Clinical trial data to be made available for download.

June 30, 2014

Clinical trial data submitted for market authorization in the European Union must be made available for downloading for academic and non-commercial research purposes.

Clinical trial data submitted as part of marketing authorization applications in the European Union will be available for downloading, saving and printing for academic and non-commercial research purposes, the European Medicines Agency (EMA) has said.

The EMA has been planning such a move since 2012, but a policy update revealed in May suggested the results would only be viewable on-screen rather than downloadable. A move more favored by the pharmaceutical companies for reasons such as patient privacy.

The change in policy followed concerns from the European Ombudsman Emily O'Reilly, who felt that clinical data only to be seen on-screen would prevent researchers from downloading the data.

The change to the draft disclosure policy announced last month by the EMA "will not only allow the agency to proactively publish clinical trial data that are submitted as part of marketing authorization applications, but also give the possibility to download, save and print the trial data for academic and non-commercial research purposes."

The European Medicines Agency (EMA) is a decentralized agency of the European Union (EU), located in London. It is responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in the EU.

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