The Measures applies to the overseas pharmaceutical manufacturers having gained or applying for Imported Drug License (for foreign pharmaceutical manufacturers) or the Pharmaceutical Product License (for pharmaceutical manufacturers of HK, Macau and Taiwan of China). The on-site inspection covers whether the actual production process is in accordance with the pharmaceutical registration application dossiers and the required materials submitted by the corresponding representative agency in China of the overseas manufacturer after receiving SFDA’s inspection notice; whether the production process complies with the GMP requirements (Good Manufacturing Practice for Drugs, 2010 Revision), etc. Any overseas pharmaceutical manufacturer refuses to take the inspection without any due reasons or don’t cooperate with the SFDA’s inspectors will be determined as it fails the inspection directly.

If the manufacturer fails the inspection with an inspection conclusion of non-conformance to requirements, its representative agency in China will receive the Warning Letter from SFDA, which orders a suspension of the drug import or the drug registration. The suspension will last until the manufacturer passes the next on-site inspection. At the same time, SFDA will inform all the Drug Administrations at ports to stop the issue of relevant Drug Import Note temporarily. Before passing the next inspection, the drug will have no access to China. As for the already imported drugs, they will be ordered to withdraw or to be handled by other measures accordingly. The table below is three inspection conclusions and their corresponding situations for reference: