European court affirms EMA's policy on study data

By AuntMinnieEurope.com staff writers

January 23, 2020 -- The European Court of Justice has affirmed a policy maintained by the European Medicines Agency (EMA) on the transparency of data from clinical studies and toxicology reports.

Two companies had filed complaints with the EMA charging that its release of clinical study reports and toxicology reports might pose a threat to their commercial interests, according to an article by the Regulatory Affairs Professionals Society.

However, the Court of Justice reaffirmed the principle of the widest possible public access to EMA data. An exception would be made only if the holder of a marketing authorization could show that disclosure would "pose concrete harm to the commercial interests" of those involved.

That standard was not met in the current case, and therefore the judges ruled that exceptions to the transparency rule must be applied narrowly.


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