March 2022: Germany Regulatory Update

An announcement was published on March 07, 2022, on the BfArM website regarding the publication of the results of clinical trials according to Section 42b of the Medicines Act (AMG).

This announcement is an addition to the update posted by the BfArM on January 27, 2022 (Changes in the legal requirements according to  Section 42b AMG). It mainly addresses questions regarding results reporting that are frequently asked to the authorities. The important question answered in this notice are:

  • Who is legally obliged to submit results reports on clinical trials to the higher federal authority for publication in a database according to Section 67a sub-section 2 AMG?

Section 42b sub-section 1 AMG applies to the pharmaceutical companies based in Germany, in other member states of the European Union, or a Contracting state of the Agreement on the European Economic Area. These companies will need to report the results of clinical trials with medicinal products for human use to the higher federal authority only for trials conducted in any third country.

  • When are the results reports on clinical trials to be submitted?

According to section 42b sub-section 1 AMG, the results reports for clinical trials must be submitted within 6 months after the approval has been granted (this also applies to subsequent changes to the approval). To speed up the process, the results report should preferably be submitted to the competent higher federal authority together with the application for approval of the trial, according to Section 21 AMG.

If a report required under Section 42b sub-section 1 AMG is already published in the database under Section 67a AMG, a reference for the result should be provided. Further details on the referencing will be specified in a separate notice.

In addition to the above-mentioned questions, the notice also clarifies the type of clinical trials requiring results reporting, requirements for bioequivalence studies per Section 42b, the format in which the results need to be reported, etc.

More information on this announcement can be found here.