According to section 42b AMG, in certain cases, result reports of clinical trials have to be submitted to the relevant higher federal authority (Bundesinstitut für Arzneimittel und Medizinprodukte or Paul-Ehrlich-Institut). Subsequently they will be published on PharmNet.Bund.

Submission of result reports

Under the new law, according section 42b sub-section 1 AMG, all the results of confirmatory clinical trials in third countries to prove the efficacy and safety of the medicinal product must be reported the competent higher federal authority.
These reports are to be made available within six months subsequent to the granting or modification, if the modification is based on confirmatory clinical trials, of the marketing authorisation or authorisation.

New portal for electronic submissions

The new portal for electronic submissions was redeveloped as part of the implementation of the "Onlinezugangsgesetz" (Online Access Act). The new portal must be used for all new initial submissions for confirmatory clinical trials in third countries under the responsibility of the BfArM according to section 77 AMG.

The medicinal products under the responsibility of the PEI will be included in the next step.
For submissions for medicinal products under the responsibility of the PEI, the previous submission portal will still be available, see below.

Previous portal for electronic submissions

For subsequent submissions or submissions under the old law (transition phase), as well as for medicinal products under the responsibility of the PEI, the previous submission portal will still be available here until the end of 2025:

Publication

The responsible higher federal authority will examine the submitted results and pass them on to BfArM for publication.

The following applications are available for searching for results reports:

• Application "Clinical Trials" on the German website (application partly accessible in English)
• Drug Information System of the National Competent Authorities