Pharmacovigilance Services in Germany

The Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) is responsible for overseeing post-market safety surveillance for pharmaceutical and allied Pharmacovigilance products services in Germany. Clinical trials cannot capture the entire safety profile of a pharmaceutical product since these investigations are conducted on a small number of subjects which typically do not represent the entire public with respect to medical practices. Thus, not all adverse drug reactions are shown and cannot be observed. It is these rare reactions that provide important information about the safety profile of a pharmaceutical product. Indeed, new findings associated with the safety profile of a pharmaceutical product can emerge after it has reached the market. Under the German Medicines Act, BfArM are required to continuously monitor and systematically collect & evaluate safety information for a pharmaceutical product that has obtained approval. This responsibility is of the Pharmacovigilance Division who also ensure that patients, healthcare professionals, and other stakeholders are made aware of these risks and ways to mitigate them, if applicable.

DDReg is a leading global contender within pharmacovigilance services and understands the importance of identifying crucial safety information and reporting it in a timely manner. Post market safety surveillance is a crucial part of DDReg’s pharmacovigilance services in Germany that constitute adverse drug reaction reporting, signal detection & management, development & submission of aggregate reports and risk management plans.