Arzneimittelaufsicht

Arzneimittelaufsicht is the public oversight of medicines to ensure their quality, safety and efficacy throughout the product life cycle, from development and authorization to manufacturing, distribution and post‑marketing surveillance. It encompasses licensing, manufacturing controls, pharmacovigilance and enforcement actions designed to protect public health and to provide reliable medicinal products for patients.

In Germany, responsibility for Arzneimittelaufsicht is shared mainly by the Federal Institute for Drugs and Medical Devices (BfArM) and the Paul‑Ehrlich‑Institut (PEI). BfArM handles marketing authorizations for most human medicinal products, evaluates new applications, and conducts inspections of manufacturers, wholesalers and distributors. PEI primarily oversees vaccines and certain biologics. Both agencies operate under national legislation such as the Arzneimittelgesetz (AMG) and EU law, coordinating with the Länder on enforcement and pharmacovigilance tasks.

Key processes include the licensing of medicines (Zulassung) after assessment of quality, safety and efficacy; ongoing pharmacovigilance with adverse drug reaction reporting and periodic safety update reports (PSURs); and risk management planning. Compliance with good manufacturing practice (GMP) and good distribution practice (GDP) is required, with inspections and corrective actions as needed. Post‑marketing actions may include safety communications, recalls, or market withdrawal.

EU context shapes the framework through directives and regulations, with the European Medicines Agency (EMA) coordinating central procedures and national authorities implementing national authorizations and surveillance. This system aims to balance timely access to innovative therapies with rigorous safety and quality standards for medicines available to patients.