New process fast-tracking drug approvals
Print Edition
China has adopted a fast-track approach in its drug evaluation and approval system, allowing more new domestic drugs, innovative drugs and imported drugs to hit the market in 2018.
Last year, the Center for Drug Evaluation of the State Drug Administration recommended approval of 59 imported branded drugs and 11 new domestic drugs, including two traditional Chinese medicines, according to an SDA statement.
Most of the newly approved drugs were anti-cancer, antiviral and orphan drugs (drugs for the treatment of rare diseases). Among them, 18 were antineoplastic while many were for tumor indications, which will bring about more therapy alternatives for chemotherapy, the SDA said.
The speedy approval of some specific medicines has enabled Chinese patients to receive better treatment. For instance, China in May approved Epclusa for the treatment of adults with chronic Hepatitis C infections, the latest treatment for the disease.
China also created a special channel for clinical drug trials, which previously took two to three years after application but is now only 60 days, if there are no queries or negative feedback.
The SDA Center for Drug Evaluation has communicated more with drug enterprises in new drug research and development. As of December 10, the center had received and handled a total of more than 1,500 communication applications, the statement said.
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