December 2020: Germany Regulatory Update

Update from BfArM on How Should the Final Report be Submitted?

An update was posted on the BfArM website on December 29, 2020:

FAQ section of observational studies has been updated with How should the final report be submitted?

The final report should be submitted as a non-copy-protected PDF document in electronic form within 12 months after the end of data collection. The reports must contain all results regardless of whether they are favorable or unfavorable. According to Section 42b, Paragraph 3, Clause 4 AMG, the following applies: With the exception of the name and address of the pharmaceutical company or the sponsor and the indication of the name and address of investigators, the reports under Clause 1 may not contain any personal, in particular patient-related data. The submitter must blackout the relevant information. The final reports submitted are made available to the public by the competent higher federal authority via an internet portal.

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