The MFDS received the results of testing and testing of Nitrosamine impurities from domestic pharmaceutical companies, and prepared safety management guidelines as a follow-up measure.

This guideline is for safety management of N-Nitrosamines, a mutagenic and carcinogenic impurity among drugs, and it should be implemented by raw and finished drug manufacturers and importers to reduce or prevent impurities within the daily intake allowance.

Starting with high blood pressure medicine (Valsartan) in 2018, tuberculosis medicine (Rifampicin) in 2021 as Nitrosamines were detected in drugs every year until Rifampicin), and new mutagenic impurities were recently detected, the MFDS received a test