The Ministry of Food and Drug Safety (Minister Yu-Kyoung Oh) will change and ease the stability test submission data requirements for approvals (and changes) of metformin-containing preparation that had been strengthened following the detection of an impurity (N-nitrosodimethylamine (NDMA, NDMA).

Metformin is used for the treatment of Type 2 diabetes and has been approved for 120 single-agent and 1,227 combination drug products.

The government’s action follows a scientific analysis of NDMA-related stability test data that have been submitted to the MFDS to date and the conclusion that the changed data requirements are sufficient to ensure the quality of the drugs within their expiration