China: Imported Drugs Must Have Local eMonitoring Representative

Drugmakers importing drugs into China must designate a local pharmaceutical company, wholesaler, subsidiary or other office as their electronic monitoring agent in the country, according to the State Food and Drug Administration (SFDA). In a Jan. 29 notice, the SFDA said overseas drugmakers must appoint a Chinese agent to handle all emonitoring activities, including uploading product barcodes and facilitating drug recalls. Additionally, the local agent will be responsible for reporting vigilance findings to the SFDA. The requirements take effect Dec. 31.
International Pharmaceutical Regulatory Monitor