Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM)

This sponsor has funded 5 studies across 9 countries.

PAS funded by this sponsor.
EU PAS ID Status RMP requirement Title Protocol uploaded Results uploaded
3435 Ongoing Not included in RMP The safety of anti-tumor necrosis factor-α (TNF-α) agents in pregnancy. An observational prospective multicenter study (TNF-α Blocker in Pregnancy) No No
3953 Ongoing Unspecified Pharmacovigilance in gerontopsychiatric patients (GAP) No No
6539 Finalised Not included in RMP Pharmacoepidemiological Safety Study of Neuroleptics and Antidepressants in the Area of Geriatric Psychiatrics (PhaSiNAg) No Yes
7034 Finalised Not included in RMP Off-label use of neuroleptics and antidepressants and risks of psychostimulant use in ADHD patients during childhood and adolescents (OLUNAR) No No
49089 Planned Not included in RMP Endogenous formation of nitrosamines from drug substance (GITox) Yes No

PAS by Risk Management Plan (RMP) requirement

Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM)

The RMP for a medical product outlines strategies to identify, assess, and mitigate risks, including PAS for further evaluation.

Category 1 studies are imposed as condition of marketing authorisation.
Category 2 studies are imposed as specific obligation of marketing authorisation.
Category 3 studies are required under other circumstances.