Research On Improving Pharmaceutical Qualified Person System In China

Drugs quality and safety is the most important common concern for global authorities of drug administration, international organizations and pharmacy enterprises. In China, along with the continuously developing of the social economy, there are still very stand out conflict of people's health care increased demand with relatively shortage of health care supply. The problems on drug safety and quality risk management divulge and appear continuously at our country now, which make big austere challenge for our countries' drug safety administration, but those problems appeared by stages in developed countries when came into the modernization, industrialization situation.Qualified person institution is an important measure to assure drug quality, is also an important part of the drug quality administration system in developed countries. Researching this institution on category, method, application, laws and experience, summarizing other countries mature experience will be very useful for our country to establish and perfect this institution based on our industry situation.This thesis used document research and comparison methods, through compare Sino-foreign institutions of qualified person's, and theories of quality management, quality control and agent of quality manager, analyzed problems of the institution of our country, the put suggestion on how to perfect this institution. Our country should define the role in law and function of qualified person firstly, enactment clear engage qualification and administration requirement at the same time; and subdivide the quality responsibility; strengthen their continuing developing management.