Drug regulation is the most important policy to ensure drug safety.In this article,we analyzed institutional changes and problems in China＇s drug regulation.In addition,suggestions were provided to enhance the capacity of drug regulation,including a clearer functional positioning for drug regulation,increased resource inputs in drug regulation at central level,a more rational allocation of vertical drug regulatory functions,and an improved supervision mechanism for regulatory departments.
To evaluate the impact of GMP on Chinese pharmaceutical industry in a quantitative system, we referred to theories on policy evaluation and industrial organization, and conducted literature review, key person interview, multi-round Delphi and field investigation. We set up the principles to construct our indicator system, reviewed based on the policy objectives of the new GMP for drugs systematically, and analysed the influence path of the new GMP for pharmaceutical manufacturers. We proposed a three-dimensional ＂structure-conduct-performance＂ evaluation indicator system. Our evaluation indicator system is accepted by experts and relevant personnel, indicating the three-dimensional evaluation indicator system is feasible to evaluate the impact of the new GMP in Chinese pharmaceutical industry.
Stakeholder analysis was conducted to define stakeholders and their role in clinical trials; a conceptual model and hypotheses regarding the relationship of each stakeholder were then constructed based on pharmaceutical regulations in China and interviews with experts; Amos 17.0 was utilized to test the model and path analysis. We found that government and hospital are the most powerful stakeholders, while the public and sponsor have little impact on clinical trials. Further measures should be taken by sponsors to promote the development of clinical trials, and the public should be more involved in clinical research.
This paper presented detailed information about the timeline of development of drug risk management in FDA. The time process was divided into three stages： the launch of laws and regulations of drug risk management, pre-market approval and post-market safety supervision, adverse drug reaction and risk communication. To address the problems existing in drug risk management in China, suggestions to further and improve the development of drug risk management are proposed.
It is critical to ensure the safety and efficacy of human drugs through drug administration. Drug administration has a long history in developed countries, such as USA, European Union and Japan, and has achieved great success. In this study, we summarized the important changes in the practice of drug administration in USA, European Union and Japan since 1990s. We also discussed how these changes and experience could be applied in the reform plan in drug administration in China Food and Drug Administration （CFDA）. Our suggestions on future development of CFDA include improving post-market surveillance, advancing regulatory science, strengthening service-oriented regulation, and international cooperation.
