The Drug Import Regulation, issued by the State Food and Drug Administration and in effect since January 1, 2004, allows for the faster sale of imported medicine. Imported drugs can now be sold immediately upon clearing customs. Previously, the sale of imported drugs was delayed for 30 to 90 days while local authorities inspected and tested the products. This process of sampling and inspection will now take place while imported drugs are on the market. Importers and manufacturers are responsible for ensuring quality control and consistency during the inspection phase.
Drugs coming to China for the first time or those belonging to one of 32 categories of biomedicines, such as vaccines and blood test reagents, must pass customs in Beijing, Shanghai, or Guangzhou. These branches are equipped with world-class facilities and personnel. Otherwise, drugs can go through customs offices in one of 18 cities.
In another development, imported drugs must be reported to newly created offices at local customs branches, then go through testing with the drug inspection services.