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China Brings More New Drugs to Market With Fast-Track Approval

Nine of the 11 domestic drugs are now approved across the world.

China has adopted a fast-track approach in its drug evaluation and approval system, allowing more new domestic, innovative and imported drugs to enter the market in 2018.

Last year, the Center for Drug Evaluation of State Drug Administration (SDA) proposed to approve 59 imported branded drugs and 11 new domestic drugs, including two traditional Chinese medicines, according to an SDA statement.

Nine of the 11 domestic drugs were first approved across the world.

Most of the newly approved were anti-cancer, antiviral and orphan drugs (drugs for the treatment of rare diseases). Among the approved ones, 18 were antineoplastic while many were for tumour 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. In May, China approved Epclusa for the treatment of adults with chronic Hepatitis C virus 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 reduced to 60 days now, if no queries or negative feedback are returned to the applicants. [APBN]

Source: China Daily