March 2022: Germany Regulatory Update

The German authority (BfArM) had recently updated the requirement for results posting according to Section 42b of the German Medicines Act (AMG) for trials conducted for medicinal products in humans on January 27, 2022.

According to this update, as of January 27, 2022, the previously applicable Section 42b paragraph 2 AMG has been repealed, i.e., there is no longer any obligation for the sponsors of clinical trials with medicinal products that have been approved/approved in the central procedure for placing them on the market to submit results reports to the competent higher federal authority.

The German authorities were asked a few questions to clarify the period/timeline from when this new regulation would be applicable.

The authorities confirmed that the new regulations do not provide for a transition period for the amendment of Section 42b AMG. The amendment applies directly as of January 27, 2022. Therefore, any studies that had a deadline to report results after January 27, 2022, no longer have to submit the results after January 27, 2022, regardless of when the study ended.

Further, it was also stated that for submissions of results reports according to Section 42b paragraph 2 AMG, which should have been done regularly until January 27, 2022, and for which the requirement was not met in time, the obligation to submit a result report remains unchanged.