China Orders Foreign Drug Companies to Designate Local Agents
China's State Food and Drug Administration (SFDA) issued a Notice on 29 January 2013 to provinces, municipalities and ports concerning the implementation of the national electronic monitoring system for imported pharmaceuticals, which will require foreign-based companies to have a local designate.
Foreign companies must designate a local Chinese pharmaceutical company, pharmaceutical wholesaler, subsidiaries or offices as their electronic monitoring agent in China. The local agent will be responsible for complying with the electronic monitoring requirements for the foreign company's imported drugs, and reporting to SFDA.
The requirement will take effect as of 31 December 2013. The notice includes links to the following registration forms:
- Imported drugs electronic supervision agency reporting formats and requirements (RAR File)
- Imported pharmaceutical enterprise network registration format and requirements (RAR File)