Research On The Management Of Drug Registration About The Medicine Production Enterprise

According to the Drug Registration Regulation Approach, Drug registration is the regulatory process executed by SFDA, according to the legal produces, executing the drug's security, effectiveness and quality control and deciding whether agree the application or not. In fact, Drug registration bring the whole drug development procedure into its management system, which related to the survey, project approval, preclinical studies, clinical reporting, clinical trials, production reporting, production licenses obtaining, etc. Therefore, the management of drug registration consists of the R & D process, contents, technical requirements and organization structure.Along with the development of drug registration, SFDA promulgated new regulations and technical requirements associated with the drug development. Due to these new regulations and technical requirements, pharmaceutical R & D staff must conduct additional studies. Otherwise, problems as increasing the time and cost of R & D and drug registration, then increasing relative risk will appear.This study uses the medicine production enterprise as the entry point and introduces the management of the company systematically.Firstly, according to registration of chemical classification, the Drug registration application includes application for new drug, application for generic drug. This paper divide the registration of the drug development process into six stages and summed up the development process, formed a complete flow chart of drug registration.Secondly, according to the guiding principles and technical requirements published by SFDA, technical requirements of the research in the pharmaceutical R & D are summarized. Those requirements relate to crafts research, quality research, structure confirmation and stability research on API are as the same as the preparation. We can guide the production process and quality control after drug listing by the results of the research.Finally, according to the procedure, technical requirements and problems exist at present, the study discusses the management of Drug registration. The study discusses the drug's surgery, project approval and registration, then forms a whole management mode. Combining the practical situation, it points out the problems needs to be paid attention, the difference between new drug and generic drug, and the management mode about the surgery. It briefly describes the drug research management about crude drug and preparation. It introduces the reporting produce about Drug registration and clearly describes the Drug registration Commissioner, including the definition, job duties, occupation requirement, etc. It arises the management mode of Medicine Production Enterprise and explains the responsibility of different department in the Drug registration system.Through this research, drug developers can get a full understanding of policy on Drug registration, Drug registration's process and technical requirements, and then reduce the risk of drug development and increase the economic efficiency of enterprises.