Submission of Clinical Trial Applications
As of 31 January 2023, clinical trial sponsors must enter all new clinical trial applications into the Clinical Trials Information System (CTIS) pursuant to Regulation (EU) No. 536/2014 on clinical trials on medicinal products for human use.
Submissions Must Be Made in Electronic Form via CESP in Accordance with GCP-V
In some cases, ongoing clinical trials are still running under the provisions of the Ordinance on the implementation of Good Clinical Practice in the conduct of clinical trials on medicinal products for use in humans (GCP-V). The Paul-Ehrlich-Institut requests that applications for such trials regarding subsequent amendments that require approval be submitted exclusively in electronic form pursuant to section 10 of the GCP-V.
This also applies to other communications, such as terminations, Development Safety Update Reports (DSURs), temporary holds, urgent safety measures (USM), and result summary reports in accordance with GCP-V for which the initial application was not submitted electronically.
Electronic submissions must be made via the Common European Submission Portal (CESP). Applications via Eudralink or by email will not be accepted and will not be considered as submitted.
Information on Format of Submissions
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