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

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

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

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”.

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 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

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

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

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

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)

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