Reporting of Adverse Events to BfArM

Sorry for mixing German and English in this post.

Over the past days, I had a discussion with our Pharmacovigilance unit on the reporting requirements regarding Adverse Events. I first questioned, whether it is necessary to perform a Sponsor Causality Assessments (SCA) for all non-serious Adverse Events. The German law "Arzneimittelgesetz" (AMG) requires in § 63b (4):

Der zuständigen Bundesoberbehörde sind alle zur Beurteilung von Verdachtsfällen oder beobachteten Missbrauchs vorliegenden Unterlagen sowie eine wissenschaftliche Bewertung vorzulegen.

The previous sections (§ 63b (1)-(3) talk about Suspected Serious Adverse Reactions, whereas (4) only refers to Suspected Adeverse Reactions. This means that all Adverse Events first have to be assessed with regard to relatedness and consequently all Adverse Events where relatedness is "unknown, not likely, likely, possibly, probably", i.e. all AEs where relatedness is not set to "not related", need to be reported.

After having consulted a considerable amount of secondary material I had to conclude that my argumentation did not have sufficient bearing to go away from the current procedure.

However, since this issue only concerns PSURs (Periodic Safety Update reports) and not Clinical Study Reports and does not require blinded data, we could remove this bottleneck from the Clinical Development Process.