Publication of and access to clinical-trial data — update - .PDF file.
On 5 December 2013, the Court of Justice of the European Union (CJEU) published its decision on the appeal of the European Medicines Agency (EMA) to the order of the European Union General Court (EGC) for interim measures concerning the access of a third party to documents held by the EMA in relation to an application for authorisation to place a medicinal product on the market. It was reported in November 2013 that, in contrast to the decision of the EMA to grant a third party access to clinical study reports in regard to medicinal products, the EGC had held that the EMA decision be suspended and that the EMA is ordered not to disclose the documents in question…
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