If the applicant / marketing authorisation holder has submitted an RMP for the product, the RMP submitted later should adopt an updated format. Each RMP submitted shall have a unique version number and date. There is no specific time requirement for the regular RMP update, and RMP is usually required in the following cases: first, the regulatory authority requires the update; The second is the modification of the risk management system, especially the modification caused by the receipt of information that may lead to important changes in the balance of risk and benefit, or as important pharmacovigilance, or reaching risk minimization milestones. (EMA GVP module v-risk management systems (Rev 2))