According to the Drug Administration Law of the People's Republic of China, the Implementation Regulations of the Drug Administration Law of the People's Republic of China and the Measures for Drug Registration Administration, before the listing of generic drugs, the drug applicant shall, as required, submit the relevant drug registration application to the Center for Drug Evaluation (CDE) of the State Drug Administration. After acceptance by CDE and completion of technical review, it is transferred to the National Drug Administration (NMPA) for approval or not.

The applicant shall file an application for registration of imported or domestic generic drugs with the Center for Drug Evaluation (CDE) of the State Drug Administration in accordance with the law. For imported or domestic generic drugs, the domestic applicant is an enterprise or drug development institution that is legally registered in the People's Republic of China and can independently bear the corresponding legal responsibility; The overseas applicant shall be a legitimate overseas pharmaceutical manufacturer, and the overseas applicant shall designate an enterprise legal person in China to handle the relevant drug registration matters. Registration objective: to obtain Import Drug Registration Certificate/Pharmaceutical Product Registration Certificate or drug approval number. After obtaining the drug registration certificate, the applicant shall be the holder of the drug marketing authorization.

Type of registration Imported or domestic generic drugs, drug registration according to traditional Chinese medicine, chemical drugs and biological products classification registration management. Registration data requirements Chinese medicine should meet the requirements of the "Notice of the State Food and Drug Administration on the Release of Chinese Medicine Registration Classification and Application data Requirements" (No. 68, 2020). Chemical drugs shall meet the requirements in the Notice of the State Food and Drug Administration on the Release of Registration Classification and Declaration Data Requirements of Chemical Drugs (No. 44 of 2020). Biological products should meet the requirements of the Notice of the State Food and Drug Administration on the Release of biological products Registration Classification and Declaration Data requirements (No. 43 of 2020).

• Analysis of the feasibility of the product for drug registration in China according to Chinese regulations (including whether it is suitable for expedited listing registration procedures)

• Provide an outline list of declaration materials;

• Gap analysis of registration data, pre-examination combined with variety information, and put forward modification suggestions to customers

• Review, translation, preparation and submission of registration materials in CTD format

• Registration inspection sampling, application, tracking and problem solving

• Full tracking of the official review of drug registration, CDE issued answers to questions and submitted supplementary reply materials.