14 August 2018 - The European Medicines Agency has scaled back its landmark clinical trial data policies, the drug regulator has announced.

Policy 0043, which granted public access to documents in the regulators’ archives, including clinical trial data, is now limited to EU citizens only, and work related to publishing new data packages under its clinical data publication policy (policy 0070) has been suspended. The agency said that the cutbacks were a response to an “excessive workload” and were part of its planning amid substantial staff loss as it prepared for Brexit.

Transparency advocates have described it as a blow to critical transparency efforts with potential patient safety ramifications.

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