Amid the recent recall of sitagliptin combination products due to excess detection of impurities, the Ministry of Food and Drug Safety appears to be busy preparing a system to manage unintentional impurities at all times.

The MFDS aims to revise the 'Guideline for Safety Management of Impurities in Drug Products’ within June to establish and advance a permanent pharmaceutical industry-led system for managing unintentional impurities in drugs.

The revised guidelines will reflect the latest advances in Korea and abroad such as new impurity tolerance standards, causes, and reduction strategies, and measures such as information collection, risk assessment, testing, and reduction.