Items that can change the risk management plan (RMP) cycle up to three years have been determined. The Ministry of Food and Drug Safety recently enacted an amendment (draft) to the 'drug risk management plan guidelines and specifically included the targets for changing the RMP reporting cycle, related documents, and procedures for reviewing the feasibility of the change.

In the case of RMP-submitted drugs, safety evaluation or benefit/risk evaluation, such as clue analysis, is conducted every 6 months from item approval until 2 years, and every 1 year after 2 years have elapsed, and the results are submitted after the expiration of the relevant period. It must be reported to the Ministry of Food and Dru