Pharmacovigilance Inspections by BfArM

Legal Basis and Objectives

Pharmacovigilance inspections in Germany are conducted under the German Medicines Act (AMG), EU pharmacovigilance legislation (Regulation (EU) No 1235/2010 and Directive 2010/84/EU), and Good Pharmacovigilance Practices (GVP) guidelines. The primary objective is to assess whether marketing authorisation holders (MAHs) have established and maintain an effective pharmacovigilance system capable of monitoring and evaluating the safety of authorised medicinal products throughout their lifecycle. Inspections help ensure timely detection of risks, appropriate risk minimisation, and compliance with reporting obligations. Pharmacovigilance inspections - BfArM

Scope of Inspections

BfArM inspects:

• Marketing authorisation holders (including those without manufacturing sites in Germany)
• Pharmacovigilance service providers acting on behalf of MAHs
• Contract research organisations involved in pharmacovigilance activities
• Systems covering adverse reaction collection, case processing, signal management, periodic safety update reports (PSURs), risk management plans (RMPs), and post-authorisation safety studies

Inspections cover both routine (systematic) and for-cause (triggered by specific concerns) types.

Inspection Process

• Announcement: Routine inspections are usually announced in advance; for-cause inspections may be unannounced.
• Preparation: MAHs receive a notification letter with scope, requested documents, and timeline for submission.
• On-site/Remote Inspection: Assessors review documentation, interview personnel, and evaluate IT systems and processes.
• Findings and Report: A report is issued detailing observations, deficiencies (critical/major/minor), and required corrective/preventive actions (CAPA).
• Follow-up: MAHs must submit CAPA plans; BfArM verifies implementation through follow-up inspections or document review if needed.

Compliance Classification and Consequences

• Critical findings may lead to immediate regulatory actions (e.g., variation to suspend marketing authorisation, urgent safety restrictions).
• Major findings require prompt CAPA with timelines; persistent non-compliance can result in sanctions.
• Minor findings are addressed in routine CAPA without immediate enforcement.

Practical Guidance for MAHs

• Maintain robust pharmacovigilance systems compliant with GVP Modules I, II, and VI.
• Prepare for inspections by conducting internal audits and mock inspections.
• Ensure all pharmacovigilance data and records are readily accessible and complete.
• Respond promptly to inspection findings with realistic, effective CAPA plans.

Pharmacovigilance inspections by BfArM are essential to safeguard public health by confirming that post-authorisation safety monitoring is effective and compliant across the EU pharmacovigilance framework. Pharmacovigilance inspections - BfArM