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Breast cancer life-saving drug Herceptin is synchronized with port inspection and marketing
Medical Network June 12 news that breast cancer patients "life-saving drugs" Herceptin clinical shortage will be alleviated.
According to the news, the demand for breast cancer drug Herceptin has surged after it was included in medical insurance, and it is out of stock in many parts of the country. On June 11, the 澎湃 journalist learned from the Shanghai Food and Drug Administration that at present, the State Drug Administration has issued a notice allowing the drug port inspection to be synchronized with the listing. Only the port inspection will save 2-3 months.
In July 2017, Herceptin was included in the National Health Insurance Catalogue. This kind of breast cancer treatment drug, which cost about 20,000 yuan each, can be used only for less than one tenth of the original price. The demand for Herceptin has soared and there is a shortage in many places across the country.
In this regard, on the afternoon of May 31, 2018, the pharmaceutical company Roche Pharmaceuticals replied that the company had applied to the State Drug Administration to apply Hercein, which supplies the Chinese market, from the existing production base to a higher capacity. Production base. At present, this request has been approved, but the production and inspection release of the product takes a long time, and it will take some time to comprehensively improve the supply of Herceptin in the Chinese market.
On June 11, the 澎湃 journalist learned from the Shanghai Food and Drug Administration that on June 8, the bureau had received relevant approval from the State Drug Administration, and agreed to conduct port inspection and listing sales for Herceptin in a certain period of time. .
It is reported that for Herceptin, which applied for import before December 31, 2018, the port drug inspection institute will be allowed to import and record after on-site verification and sampling. The products are listed and sold on the “Imported Drugs Customs Clearance Form†and the factory self-inspection report.
At the same time, the drug inspection work after sampling continues to be carried out in accordance with the normal procedures. If the inspection does not meet the standards, it shall be handled in accordance with the relevant provisions of the Measures for the Administration of Pharmaceutical Imports.
On the other hand, Shanghai Roche Pharmaceutical Co., Ltd. should fulfill its obligations related to drug quality management and assume responsibility for risk prevention and handling during use.
澎湃News reporters learned from relevant people in the industry that it takes a long time for enterprises to organize the production of biological products and inspection release. After importing drugs, according to the relevant national regulations, they must also pass the designated drug inspection agencies, and they can be put on the market after passing the inspection. After the port inspection and the listing and sales are synchronized, the import speed of Herceptin can be shortened by 2-3 months only by one port inspection.