The Ethical Surveillance And Control Of Drug Safety In China

Drug safety has become one of the hottest public medical safety issues in 21st century, and the safety inspection is the critical support of the prevention of drug safety problem. On the basis of analyzing the double sides of drugs, drug exploring, producing and potential risks of drug use, this article discussed the inspection of drug safety from the angle of ethics, and initially brought the concept of ethical inspection in drug safety, meanwhile, implemented a systematic research in the importance, imperativeness, feasibility, and methods of ethical inspection of drug safety.This article cut in from the change of moral environment under the background of developed drug market, analyzed the ethical inspection of drug safety, defined initially the function of ethical inspection in drug safety field, constructed the system of the ethical inspection, defined the drug safety inspection before and after marketed as the external ethical inspection of drug safety, and defined the drug exploration, approval, produce, market management, recall of problem drug as the internal ethical inspection, and analyzed the association of two ethical inspection systems.This article initially brought the idea of evaluation system used in ethical inspection of drug safety, analyzed the subject, object and nature of the evaluation system, analyzed the process, differences, dynamic, objectiveness of ethical inspection of drug safety, pointed out the position, function, evaluation criteria, method and procedures of ethical inspection committee in the ethical inspection evaluation.