Hinder China's Pharmaceutical Manufacturers Voluntarily Recalled Reason And Strategy Of The Security Risks Of Drugs

The level of the national drug regulatory is the embodiment of social progress and civilization degree, ensure all members of the drug is safe and effective society, safeguard the fundamental interests of the public, is shouldering the sacred mission of government supervision department. Face the fact that the ADR events have occurred in the face of the weak part of the enterprise honesty and law-abiding consciousness, in the face of increasing public awareness of safe use of antibiotics, scientific and normative drug safety regulation is to control the drug safety risk, the important measures to minimise the risk of the ADR events. At present the U.S. Food and Drug Administration (Food and Drug Administration, FDA) in Drug regulatory has a set of perfect system for Drug recall, for unsafe drugs companies to voluntarily recalled in a timely manner, in order to ensure the safety of the public. In our country, although in2007the "drug recall management method", but in reality drug recall related management system, recognition and recall information main source, drug recall ability of enterprises, government regulation, consumer cognition, media guide, recall risk transfer and so on a series of problems, still hinder is voluntarily recalling the smooth implementation of the drug.This article from the perspective of government regulation of the influence enterprise is voluntarily recalling drug safety hazard factors, this paper probes into the problems in the link of government’s rules and regulations, and put forward the Suggestions and measures to solve the problem, improve the company is voluntarily recalling post-marketing drug safety hazard mechanism, to ensure drug safety for the people.This paper will be divided into five parts:The first part, introduces the research background and significance, the related theory and concept definition, research methods and technical route, the related research literature review.The second part, the drug recall system in China and the United States is voluntarily recalling a comparative analysis.The third part, through the review and analysis of the typical cases, presents the present situation of our country’s implementation of the drug is voluntarily recalling.The fourth part, to hinder our country enterprise is voluntarily recalling safety risk factors of the drug were analyzed.The fifth part, the link of the drug recall system in China is voluntarily recalling the deficiency of government regulation, put forward to perfect the listed drug safety assessment mechanism, establishing the post-marketing drug safety hazard causing harm compensation mechanism, standardize and improve the regulatory responsibilities and so on three aspects of the measures and Suggestions.