A drug is authorized by an agency only when it demonstrates a positive risk-benefit balance or safety profile for the target population. It is a key component of Pharmacovigilance (PV) to safeguard public health. However, information on drug safety gathered from clinical trials is limited and, at times, not relevant to the larger population that shall consume the drug once it has been marketed. Consequently, information available at the time of approval is usually sufficient only to provide a preliminary assessment of the balance between benefit and risk. Thus, Regulatory Authorities have mandated the submission of a Risk Management Plan as part of drug safety surveillance.
What is a Risk Management Plan?
- safety specification, which elaborates the current knowledge of the safety profile of the drug,
- the pharmacovigilance plan, which aims to add to the knowledge of suspected risks and fill gaps where knowledge is absent; and
- an assessment of the requirement for risk-minimization activities.
Routine minimization or more
Risk Management Guidelines: EU vs. US
RMP and REMS capabilities at DDReg
References and further reading:
 European Medicines Agency. Guideline on Good Pharmacovigilance Practices (GVP): Module V- Risk management systems. 2017
 European Medicines Agency. Guidance on the format of the risk management plan (RMP) in the EU- in integrated format. 2018
 United States Food and Drug Administration. Risk Evaluation and Mitigation Strategies (REMS). 2021