Risk Management Plan Its Importance and Emphasys on Pharmacovigilance Activities

Abstract

Risk is probability of harm being caused. Risks related to the medicinal products may be any risk relating to quality, safety or efficacy of medicinal product as regards to patient’s health or public health and any risk of undesirable effect on environment. Risk management system is a series of pharmacological activities for identification of risk, its assessment, minimization or prevention and its communication [1,2]. Risk management plan (RMP) is the complete description of risk management system. Main aim of RMP is to ensure safety of the patient using the drug. RMP’s are required to be submitted during the authorization of a drug. An updated RMP should now be submitted at the request of the national competent authority, whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the risk-benefit balance or as a result of an important pharmacovigilance or risk minimization milestone being reached.