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CFDA Unveils Its Legislation Plan in 2018


To implement the spirits of 19th CPC National Congress, following the principle of focus on the central task, serving the overall interests, highlighting priorities and harmonious promotion, and targeting at basic construction of a scientific and complete food and drug safety legal system by 2020, the legislation plan in 2018 is hereby prepared by the CFDA in accordance with the Provisions for Legislative Procedures of China Food and Drug Administration (CFDA Order No. 1) and unveiled upon the approval by CFDA affairs meeting.

There are 36 legislative programs in 2018, including:
3 laws: first, continue to push the amendment of Drug Administration Law of the People's Republic of China; second, continue to push the preparation of Decision of Standing Committee of the National People's Congress on Authorization for Partial Drug Patent Period Compensation Pilots and Exploration of Constructing Drug Patent Linkage System; third, form the drafted amendment of Drug Administration Law of the People's Republic of China to submit to the State Council for review according to relevant procedures.

3 regulations: first, continue to push the amendment of Regulation on the Implementation of the Food Safety Law of the People's Republic of China; second, accelerate the amendment of Regulation on the Supervision and Administration of Medical Devices and strive for submitting the drafted amendment to the State Council in the first quarter, third, continue to push the preparation of Supervision and Administration of Cosmetic Products.

31 policies: first, make and amend 12 supporting food policies centered on the Food Safety Law; second, make and amend 15 drug and medical device policies according to the requirements of deepening the reform of drug and medical device review and approval system; third, make and amend 4 general policies to accelerate the legal construction of food and drugs.

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