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Parliamentary question - E-000001/2020Parliamentary question

Unpublished results of clinical trials on medicinal products

Question for written answer E-000001/2020
to the Commission
Rule 138
Patrick Breyer (Verts/ALE)

At the end of 2019, the BUKO Pharma Campaign and TranspariMED organisations reported that German university hospitals had entered the results of only 32 clinical trials out of the 477 undertaken (6.7%) into the EudraCT database. Under EU law, results must be entered within 12 months. The Paul Ehrlich Institute, which is the responsible body in Germany, is said to have told a university that, in accordance with Section 13(9) of the GCP Regulation, there is no obligation on sponsors to publish the results of trials in the EudraCT database in Germany. [1]

Last updated: 25 September 2020
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