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Shanghai Free Trade Zone 9 years on / Reform and Innovation

Shanghai FTZ contributes to new drug development

en.china-shftz.gov.cn | Updated: 2022-11-01
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China (Shanghai) Pilot Free Trade Zone, which is also known as Shanghai FTZ, was established in 2013. After its establishment, the continuous implementation of a series of measures closely linked to international trade rules has benefited new drug development a great deal.

According to Tian Wenzhi, founder of ImmuneOnco, which is a biopharmaceutical enterprise, registration itself took more than a month in the past, but currently, with more efficiency brought by Shanghai FTZ, clearance time for medical materials has been reduced to a few hours.

Marketing Authorization Holder is a system introduced to lighten enterprises’ burdens. 

Before its introduction, clinical trials could only be done after a series of procedures including the production of the drug, the construction of a workshop that meets GMP standards and the inspections carried out by relevant departments. Currently, marketing authorization holders enjoy more autonomy. They can either produce drugs in their own workshops or outsource them, which has greatly enhanced the efficiency of the research and development of new drugs.

In the first half of the year, the total revenue of Shanghai's biopharmaceutical industry reached 386.8 billion yuan ($53.12 billion), an increase of 0.4 percent year-on-year. By August, the output value reached 116.16 billion yuan, an increase of 3.9 percent year-on-year.

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