Risk minimisation has become a crucial part of pharmacovigilance activities. Manufacturers and regulatory agencies are required to constantly monitor risks and adverse effects of medicinal products. At the same time, it is widely understood that passive gathering of information regarding the occurrence and severity of adverse reactions is not sufficient to ensure the safety of the patient. The current trends in pharmacovigilance appear to move from the traditional reactive recording of adverse reactions to more pro-active approaches.
Understandably, not all drug effects can be predicted before a new drug entity reaches the larger population but each marketing authorisation holder should be ready to react appropriately to any new information regarding the product. This includes effective communication with all stakeholders, product information updates and forward planning in order to better understand the risks and to avoid or mitigate them efficiently.
In line with legislative focus on risk management systems, the concept of risk minimisation runs through the modules of Good Pharmacovigilance Practices (GVP). Individual GVP modules refer to risk minimisation, often from a different perspective, and they need to be reviewed collectively to fully understand obligations.
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