Sharing Taiwan FDA 2020 Annual Report
Nitrosamine related activities (page 52)
Section 6 - Improvement of Drug Quality Inspection Technology
In view of the drug incidents containing nitrosamine impurities such as the N-Nitrosodimethylamine (NDMA) happening around the world, TFDA has collected international literature and has identified 44 high-risk drugs that may produce or contain NDMA by initially checking; in addition, referring to international rules/regulations, the nitrosamine impurities has been included to drugs inspection with scientific methods of monitored the high-risk products by TFDA, and through the alerts and reporting system as well as international cooperation to control the notification and ensure to enhance our capacity and capability of inspection.
2020 Taiwan Food and Drug Administration Annual Report.pdf (1.6 MB)