January 2022: Germany Regulatory Update

An update was posted on the Federal Institute of Drugs and Medical Devices (BfArM) website on January 27, 2022, regarding the Change in the legal requirements for reporting results of clinical trials according to Section 42b of the German Medicinal Products Act (AMG).

When the Act for the Restructuring of the Pharmaceutical Market in Statutory Health Insurance came into force on January 1, 2011, Section 42b – Publication of the results of clinical trials was added to the sixth chapter of the AMG.

From January 27, 2022, the legal requirements for publication of results report according to Section 42b AMG will change as follows:

  • According to subsection 1 sentence 1, the sponsors will now be obligated to report results only for confirmatory clinical trials (to prove efficacy and safety) that are carried out exclusively in third countries, i.e. exclusively in countries outside the European Union and the European Economic Area (EEA), to the responsible higher federal authority.
  • The previously applicable Section 42, sub-section 2 AMG has been repealed, ie., Sponsors of clinical trials with medicinal products which are approved/will be approved by the central procedure will no longer have any obligation to submit results reports to the competent higher federal authority for placing them on the market.
  • Furthermore, the previous notification obligation for generic approvals in connection with bioequivalence studies will no longer apply.

The content requirements for the results reports remain unchanged and can now be found in the new Section 42b sub-section 2 AMG,  that is all the results of the clinical trials must be included in the reports, regardless of whether they are favorable or unfavorable. Subsequent significant changes to the protocol as well as interruptions and terminations of clinical trials are to be included in the report. The report can be written in German or English.

An updated announcement for the publication of the results of clinical trials according to Section 42b AMG will be available shortly on the BfArM website.

More details for this article can be found here.