(Yicai Global) June 12 -- The State Administration for Market Regulation issued a circular to give the green light to breast cancer drug Herceptin’s simultaneous testing in ports and designated centers, a move that will significantly speed up its import to the Chinese market and ease supply shortage in clinical medicine.
The Shanghai municipal food and drug administration said yesterday that China Food and Drug Administration gave go-ahead on June 8 for Herceptin to be imported before Dec. 31 this year can be marketed following site testing and sampling in ports’ drug control centers and designated institutes. The drug can be supplied to the market with the imported drug customs clearance certificate and factory’s self-testing report, online news outlet The Paper reported today.
Under Chinese regulations, general drugs can only be distributed in the market after they pass testing in ports and designated institutions, the report said, citing an insider. Following the approval, Herceptin imports are expected to increase significantly.
China last year included Herceptin in the medical insurance directory, after which patients who previously needed to pay CNY20,000 (USD3,120) per dose could spend only less than one tenth of the original price thanks to the medical insurance system. This has led to a sharp rise in the demand for the drug and a supply shortage in some regions across China.
Swiss pharmaceutical giant Roche Holding, a manufacturer of Herceptin, said that the company has been approved by relevant government departments to change the existing production site supplying Herceptin for the Chinese market to a higher-capacity production base, but it takes a long time to pass inspection process. This means it will take some time to ease the supply shortage.
Editor: Mevlut Katik