The Drug Marketing Authorization Holder Mechanism: Moving Forward through Exploration
摘要
On 6 June 2016, 7 months after the China Food and Drug Administration published the Pilot Plan for the Drug Marketing Authorization Holder Mechanism (Draft for Public Opinions), the General Office of the State Council officially released the Pilot Plan for the Drug Marketing Authorization Holder Mechanism (Guo Ban Fa [2016] No. 41) (“Pilot Plan”), which attracted public attention. According to the Pilot Plan, ten provinces and municipalities, including Beijing Municipality, Tianjin Municipality, Hebei Province, Shanghai Municipality, Jiangsu Province, Zhejiang Province, Fujian Province, Shandong Province, Guangdong Province, and Sichuan Province will implement the pilot drug marketing authorization holder mechanism. This means that drug research and development (“R&D”) institutions and research personnel within the pilot regions are now eligible to apply and obtain drug marketing authorizations and drug approval numbers. The Pilot Plan will be in effect until 4 November 2018. It demonstrates China’s strong momentum to reform the drug registration mechanism in China, to stimulate drug R&D, and push for the specialization of drug R&D and manufacturing.
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