Tasks undertaken by cde in drug registration

The task of Cde in drug registration is to provide technical support for drug registration.

The Chinese name is Drug Evaluation Center, mbth is CFDA Drug Evaluation Center, referred to as CDE, and the State Food and Drug Administration provides technical support.

CDE Drug Evaluation Center) is a technical evaluation institution for drug registration of the State Pharmaceutical Product Supervision and Administration, which provides technical support for drug registration. Responsible for organizing the technical review of drug registration application according to the regulations on drug registration management promulgated by the State Pharmaceutical Products Supervision and Administration. To undertake other tasks assigned by the State Administration of Pharmaceutical Products.

Its main functions: clinical trials, acceptance and evaluation of listing applications; Technical review of emerging medical products; Consistency evaluation of generic drugs; Inspection and verification work; Theoretical and technical research, academic exchanges and others.

The development of administrative acceptance of drug registration in China;

Based on the development history of domestic drug registration laws and regulations, this study divides the development process of administrative acceptance of drug registration in China into four stages: initial stage, formation stage, development stage and perfection stage.

The initial stage-accepted by the provincial health department and approved by the provincial health department, the formation stage-accepted by the provincial health department and approved by the national health department, the development stage-accepted by the provincial drug supervision department and approved by the national drug supervision department, and the improvement stage-accepted by the national drug supervision department and approved by the national drug supervision department.

The present situation and related contents of administrative acceptance of drug registration in China;

20 16 the former CFDA set up a leading group for administrative acceptance reform according to the general requirements of "improving the quality of application materials and establishing a more scientific and efficient drug evaluation and approval system" in the State Council, and responding to the reform concept of combining decentralization with administration in the State Council.

According to the proposed work plan of administrative acceptance reform, the administrative acceptance function of drug registration was adjusted from the original CFDA administrative matter acceptance service and complaint reporting center to the original CFDA drug evaluation center, and the administrative acceptance of drug registration was undertaken by the business management office of the drug evaluation center, which promoted the further integration of administrative acceptance and technical evaluation.

At present, the administrative acceptance of drug registration in China is based on the Administrative Licensing Law of People's Republic of China (PRC) (20 19) and revolves around the Drug Administration Law of People's Republic of China (PRC) (Presidential Decree No.31), the Regulations for the Implementation of the Drug Administration Law (the State Council Decree No.360) and the Measures for the Administration of Drug Registration (Order No.27 of the General Administration).

In the initial stage and formation of the drug registration management system, the provincial health administrative department or drug regulatory department exercised the function of receiving the application materials for drug registration, which was not mentioned separately in the rules and regulations, but was vague in the preliminary examination and approval. It was not until the first "Measures for the Administration of Drug Registration" was promulgated in 2002 that the "acceptance" behavior as a part of the registration management appeared in the drug management rules and regulations.

In 2003, the Administrative Licensing Law of People's Republic of China (PRC) solidified the status of administrative acceptance in the form of legal provisions, determined it as the initial link of administrative procedures, and further defined the implementing institutions and functional scope.

With the continuous advancement of the reform of drug review and approval system, the power of administrative examination and approval for drug registration is gradually concentrated in National Medical Products Administration, and the administrative acceptance function of drug registration is also concentrated in National Medical Products Administration according to the general requirements of document No.44 to improve the quality of registration application materials and the principles of "whoever reviews and accepts" and "whoever approves and accepts", and National Medical Products Administration entrusts its directly affiliated unit Drug Review Center to exercise it on its behalf.