Highlights on the Revised Drug Registration Administrative Measures


The revised Drug Registration Administrative Measures (the “Revised Measures”) promulgated by the State Administrative for Market Regulation (the “SAMR”) of the People’s Republic of China (the “PRC”) on 22 January 2020 will enter into force in less than one month (i.e. as of 1 July 2020).

Upon the entry into force of the Revised Measures, the Drug Registration Administrative Measures promulgated on 10 July 2007 and effective as of 1 October 2007 (the “Previous Measures”) shall be abolished as of 1 July 2020 accordingly. The SAMR also published an announcement on 30 March 2020 regarding some transitional issues between the Previous Measures and the Revised Measures (the “Notice [2020] No. 46”).

The Revised Measures are modified to implement new changes set forth in the revision of the PRC Drug Administration Law which was extensively revised in 2019[1] (the “Revised Drug Administration Law”). Besides, in lights of the Opinions on Deepening the Reform of Evaluation and Approval System and Inspiring Innovation of Drugs and Medical Devices (the “Opinions”) promulgated by the Central Committee of the Communist Party of China and the General Office of the State on 8 October 2017 for the purpose of encouraging the drug and medical device innovation in China, besides the introduction of Market Authorization Holder (the “MAH”) regime, the Revised Drug Administration Law has also introduced a series of new procedures to improve the effectiveness of drug examination, such as implied approval of clinical trial, conditional approval, priority approval, etc.

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[1] For details, please refer to the newsletter Revised Drug Administration Law dated 8 October 2019.