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...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.展开更多
文摘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.
