The State Administration for Food and Drug has approved simultaneous port inspection and market sales of Herceptin, the Shanghai Municipal Food and Drug Administration told thepaper.cn Monday.
The move saves two to three months from the time required for the drug to reach the hands of customers amid a shortage in the domestic market.
Herceptin is a targeted therapy for HER2 positive metastatic breast cancer and HER2 positive gastric cancer. Patients who lack the drug might not recover or could risk shortening their lives.
In July 2017, Herceptin was included in the National Reimbursement Drug List. The market price of the drug, which was marked 19,800 yuan ($3,092) for an injection before the inclusion, dropped 60 percent to 7,600 yuan.
As the national reimbursement scheme can cover 70 to 80 percent of the drug's cost in most regions, meaning a customer can buy Herceptin at 1,500 yuan for an injection, demand for the drug skyrocketed.
Swiss-based drug maker Roche Holding AG, the producer and sole supplier of Herceptin in China's market, said on May 31 that the company has taken several measures to deal with the shortage, including implementing the "China market priority" strategy, raising the production capacity to full steam, and optimizing logistics channels.
The company also filed an application with the State Administration for Food and Drug, asking to relocate the production of Herceptin from its current base to a new one with a higher production capacity. The application was approved May 30.
Despite the measures, the company said as it takes longer for production and inspection of the drug, and also time for import and inspection by Chinese authorities before entering the market, it still needs time to fully meet the demand.
