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Announcement of the General Administration of the People's Republic of China on Publishing the Catalogue of Listed Drugs in China (2017 No. 172)

According to the requirements of the General Office of the Central Committee of the Communist Party of China and the General Office of the State Council on Opinions on Deepening the Reform of the Review and Approval System to Encourage Drug and Medical Device Innovation (Tingzi [2017] No. 42), in order to protect the public's rights to use drugs, improve drug quality, and reduce the burden of drug use, Encourage drug R & D and innovation. The State Food and Drug Administration has formulated the "List of Listed Drugs in China". The relevant matters are now announced as follows:

I. "China's List of Listed Drugs" is a carrier for the release of information on approved drugs from the State Food and Drug Administration. It contains innovative drugs, improved new drugs, generic drugs with newly registered classification of approved drugs, and consistency of quality and efficacy Evaluate specific information on medicines. Designate reference and standard preparations of generic drugs, and mark the specific generic drugs that can replace the original research drugs, etc., for the pharmaceutical industry and medical personnel and the public to understand and query.

2. The "Chinese List of Listed Drugs" is published on the government website of the State Food and Drug Administration in an online version and linked to databases such as drug review reports, instructions, and patent information.

3. The "China List of Listed Drugs" currently released includes 131 varieties and 203 varieties and specifications, including 13 varieties and 17 varieties and specifications that have passed the consistency evaluation of the quality and efficacy of generic drugs. The State Food and Drug Administration will directly incorporate the newly registered and classified drugs that have been approved for marketing and the drugs that have passed the consistency evaluation of the quality and efficacy of generic drugs into the China List of Listed Drugs, which will be updated in real time.

  Special announcement.State Food and Drug Administration

December 28, 2017