Company profile · Bonn, Germany

BfArM Bonn

Federal Medicines Regulation, Medical Devices, Pharmacovigilance, and National Risk Assessment · Federal medicines and devices authority

GermanyRegulatory anchorBonn

Federal medicines authority governing Germany's authorisation, device oversight, and post-market surveillance backbone.

Lead
Karl Broich (verified ↗)
Address
Kurt-Georg-Kiesinger-Allee 3, 53175 Bonn, Germany (source ↗)
Compliance
Not yet on record
Last reviewed
15 Mar 2026 (3mo ago)
Scale
Federal medicines and devices authority
Capabilities
Marketing authorisation assessment · Risk information · Medical-device oversight
Founded
1994
Headcount
1001-5000
LinkedIn
Company page (open ↗)
Site and address
Clinical profileSTATUS: VERIFIED MARCH 2026

Karl Broich

President

Check official leadership source
Full addressKurt-Georg-Kiesinger-Allee 3, 53175 Bonn, Germany
Site coordinatesVerification evidence is still being completed.
Review cycleMay 2026
Physical site source

Official BfArM contact page naming Kurt-Georg-Kiesinger-Allee 3 in Bonn.

Open source
Operating profile

Federal medicines and devices authority

Bonn, Germany. Federal Medicines Regulation, Medical Devices, Pharmacovigilance, and National Risk Assessment. Review completed on 15 Mar 2026.

2026 technical specializationFederal Medicines Regulation, Medical Devices, Pharmacovigilance, and National Risk Assessment
Core capabilities
Marketing authorisation assessmentRisk informationMedical-device oversightFederal vigilance and reporting
Governance

Federal Ministry of Health and EU medicines regulatory framework

Federal medicines authority, German and EU regulatory enforcement

Editorial note

Federal Medicines Regulation, Medical Devices, Pharmacovigilance, and National Risk Assessment

Federal medicines authority governing Germany's authorisation, device oversight, and post-market surveillance backbone.

Related companies
Editorial note

BfArM is the federal German medicines and medical-devices authority that sets the regulatory reference frame for major cluster anchors in Germany.

FULL TRUST REVIEW COMPLETE
Shown only when all seven trust checks are fully mapped in the directory.
Current review cycleMarch 2026Last reviewed: 15 March 2026
Capabilities

Core capabilities

Primary declared technical activities and areas of operating focus.

Marketing authorisation assessment
Risk information
Medical-device oversight
Federal vigilance and reporting
Verification source dossier

Verification source dossier

Official source set used to support leadership, physical-site, certification, and watch-note evidence.

Leadership evidenceBfArM official head page confirming Karl Broich as President.Source origin: bfarm.deOpen source
Supporting evidenceBfArM public organisational overview and tasks surface.Source origin: bfarm.deOpen source
Physical-site evidenceOfficial BfArM contact page naming Kurt-Georg-Kiesinger-Allee 3 in Bonn.Source origin: bfarm.deOpen source
Infrastructure

Declared infrastructure

Risk assessment units
Licensing directorates
Federal reporting systems
Regulatory posture

Quality system coverage

GMP / GLP / ISO-13485 / FDA-Inspected are global quality-system standards. "Verified active" means the directory confirmed the certification is current; "Review in progress" means the cert status is currently being re-verified.

GMP
REVIEW IN PROGRESS 2026
GLP
REVIEW IN PROGRESS 2026
ISO-13485
REVIEW IN PROGRESS 2026
FDA-Inspected
REVIEW IN PROGRESS 2026
Verification history

Verification history

15 Mar 2026: Executive identity confirmed via official management disclosure.
15 Mar 2026: Full trust review completed.
FAQ

Frequently asked questions

Where is BfArM Bonn located?
BfArM Bonn operates from Kurt-Georg-Kiesinger-Allee 3, 53175 Bonn, Germany, Bonn, Germany.
Who runs BfArM Bonn?
BfArM Bonn is led by Karl Broich, President. Verified 15 Mar 2026.
What does BfArM Bonn do?
Federal medicines authority governing Germany's authorisation, device oversight, and post-market surveillance backbone. Core capabilities: Marketing authorisation assessment, Risk information, Medical-device oversight, Federal vigilance and reporting.
Editorial context

Related technical briefs

Briefs that name Bonn as a covered market or city.