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07-31

Provisions for Post-marketing Changes of Drugs (Interim)

Article 1 [Objective] These Provisions are formulated for the purpose of further regulating post-marketing changes of drugs and strengthening administrative responsibilities of drug marketing authori
Provisions for Post-marketing Changes of Drugs (Interim)
04-23

Good Clinical Practice

　　Article 1 In order to ensure the standardization of drug clinical trial conduct, the scien- tific integrity, authenticity and reliability of data and results, and the protection of rights, safety
Good Clinical Practice
06-30

Registration Classification and Requirements for Application Dossiers of Chemical Drugs

　I. Registration Classification of Chemical Drugs 　　The registration classification of chemical drugs includes innovative drugs, modified new drugs, generic drugs, and chemical drugs overseas markete
Registration Classification and Requirements for Application Dossiers of Chemical Drugs
01-15

Provisions for Bundling Review and Approval of Chemical Drug Substances, Pharmaceutical Excipients, Pharmaceutical Packaging Materials and Drug Product (Draft for Comments)

　　Article 1 (Basis & Purpose) In order to improve the quality and efficiency of drug registration and ensure the safety, effectiveness and quality controllability of drugs, the Provisions have been formulated in accordance with the “Drug Administration Law of The People’s Republic of China” and the “Drug Registration Regulation”.
Provisions for Bundling Review and Approval of Chemical Drug Substances, Pharmaceutical Excipients, Pharmaceutical Packaging Materials and Drug Product (Draft for Comments)
10-16

The registration classification and documents requirements of biological products

　Biological products are preparations that are manufactured from microorganisms, cells, animal- or human-derived tissues, body fluids etc. as starting raw materials making by biological technologies,
The registration classification and documents requirements of biological products
10-19

“The requirements for application documents for selection of reference drug of generic chemical drugs” issued by CDE (No.32 2020)

　In order to better serve the applicants and further improve the quality and efficiency of the selection of reference drug, CDE has developed “The requirements for application documents for selection
“The requirements for application documents for selection of reference drug of generic chemical drugs” issued by CDE (No.32 2020)
03-15

Provisions for Drug Insert Sheets and Labels

　　The Provisions for Drug Insert Sheets and Labels, adopted at the executive meeting of the State Food and Drug Administration on March 10, 2006, is hereby promulgated and shall go into effect as of J
Provisions for Drug Insert Sheets and Labels
01-15

Information Supplement Procedure of the Center for Drug Evaluation

　　Article 1 To standardize the management of information supplement required during drug application review, clarify the basis and requirements for information supplement, and improve the quality and
Information Supplement Procedure of the Center for Drug Evaluation
01-18

Drug Administration Law of the People’s Republic of China (2019 Revision)

　　The revised Drug Administration Law of the People's Republic of China passed by the 12th Session of the Standing Committee of the 13th National People's Congress on 26 August 2019 is hereby promulga
Drug Administration Law of the People’s Republic of China (2019 Revision)
06-29

Provisions of Drug Registration

　　（The measure of Drug Registration is approved by State Administration for Market Regulation in Order No.27 on January 22，2020）
Provisions of Drug Registration
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