New rules pave the way for faster sales of imported medicines, cutting customs waiting time by about a month.
Regulations that came into effect Thursday eliminate the practice of holding imported medicines at customs while local drug-inspection institutions check them.
Reporting, issuing customs clearance forms, inspecting samples and issuing a final pass for drug shipments would take at least 30 days.
Sometimes, inspecting samples could take up to 90 days.
Now, however, the new Drug Import Regulation from the State Food and Drug Administration will cut importers' waiting time for sample inspection, said an official surnamed Ding, of the Registration Department of the administration.
The drugs will be sold in the market as soon as they come out of customs. Samples will be tested while the drugs are already on the market.
The new rules put the onus for quality control and consistency directly on the importers' and manufacturers' shoulders.
All imported drugs must go through dedicated customs office in 18 cities.
Moreover, drugs that come to China for the first time or belong to one of 32 kinds of bio-medicines, such as vaccines and blood test reagents, have to go through customs in Beijing, Shanghai and Guangzhou. These sites have world-class facilities and personnel, said Ding.
Drugs are the only products required, by law, to go through specifically assigned customs when imported, he said.
Another change is that imported drugs must first be reported to the newly-established drug supervisory office of local customs, then go through sample testing at drug inspection institutions.
In the past drugs were reported and tested only at the latter.
(China Daily January 2, 2004)
