Pharmacovigilance Boards and Committees at BfArM

Role in National Pharmacovigilance

BfArM collaborates with independent expert advisory bodies to ensure scientifically sound and transparent decision-making in pharmacovigilance. These committees evaluate adverse reaction reports, emerging safety signals, risk management plans, and periodic safety update reports, advising on necessary regulatory measures to protect public health. Boards and committees - BfArM

Key Advisory Bodies

Pharmacovigilance Commission (Kommission Pharmakovigilanz)

• Independent expert panel advising BfArM on pharmacovigilance matters.
• Reviews serious adverse reactions, safety signals, and risk-benefit assessments.
• Composed of physicians, pharmacists, epidemiologists, toxicologists, and patient representatives.
• Meets regularly to discuss complex cases and recommend actions (e.g., label updates, restrictions, suspensions).

PRAC Representatives

• German members of the Pharmacovigilance Risk Assessment Committee (PRAC) at EMA.
• Participate in EU-wide signal detection, risk evaluation, and harmonised risk management.
• Coordinate national input into PRAC discussions and implement EU decisions in Germany.

Further Expert Groups

• Ad-hoc working groups for specific topics (e.g., vaccines, biologics, or emerging risks).
• Collaboration with Paul-Ehrlich-Institut (PEI) committees for vaccines and biologics.
• Involvement of scientific advisory councils for broader regulatory and safety issues.

Functions and Decision-Making Process

• Signal assessment: Committees review potential new risks from national and EU data.
• Benefit-risk evaluation: Advise on whether risks outweigh benefits or require mitigation.
• Recommendation: Provide non-binding but highly influential advice to BfArM leadership.
• Transparency: Meeting minutes and recommendations are published where appropriate.

Practical Impact

These boards ensure that pharmacovigilance decisions in Germany are evidence-based, multidisciplinary, and aligned with EU standards. Their work supports timely safety communications, risk minimisation measures, and regulatory actions, contributing to the safe use of medicines for patients across Germany and the EU. Boards and committees - BfArM