| Pharmaceutical products (drugs), as a special kind of goods, are closely related to public health and life safety. Drug registration administration is the first step for Drug Administration. For this reason, the management of review and approval process during drug registration is an important component of drug administration efforts in all countries. The United States is the most developed country in the world in terms of medical economy. US Food and Drug Administration (FDA), with its hundred-year history of drug administration, is the first regulatory agency responsible for drug registration and management in the world. It is a reference of the development of drug regulatory authorities in other countries. At present, drug registration administration in our country is also an important part of drug management efforts. As the development of market economy system and legal system is pushed forward more and more after China joining WTO, and the improved public awareness of safety in drug use, in recent years, the emerging issues associated with the positioning, efficiency, decision-making procedure and service function of drug regulatory system in China are increasingly becoming the focus of Central Government’s concern, public attention and industry appeal. The regulatory absence in the drug regulatory system has seriously impaired the public trust or credibility of government in terms of drug administration; hampered the persistent and healthy development of our medical economy. Therefore, it is important and realistic to actively examine and adopt the experience of developed countries, and explore the construction of a drug regulatory system suitable for our country. This will be helpful for ensuring the safety and effectiveness of public drug use, guiding pharmaceutical companies to perform with integrity and self-discipline, and enhancing the long-acting regulatory mechanism for drug safety and effectiveness. This process will finally lead to the development of a drug regulatory system characterized by fair and just, standard and order, efficiency and transparency. Based on the above-stated background, in this paper, we intend to explore the framework of drug regulatory system appropriate for the actual situations in our country by combining the basic framework of drug administration with the particularity of drug regulatory process.This paper deeply analyzed and examined the current status of drug regulatory system in China and the US by systematology theory, and by contrast, explored the phenomena and reasons of regulatory absence during drug registration in our country in terms of organization structure, decision-making procedure, policy and regulation, technology standards and regulatory service. These issues can interfere with the full building of our drug regulatory system. It is concluded that the regulatory absence in drug regulatory system in our country is caused by multiple factors. The essential solution is reform to improve the drug regulatory system by targeting specific issues.Based on theoretical analysis and actual data analysis, in this paper, we used the successful experience of developed countries in building and maintaining their drug regulatory system for reference, proposed some strategic suggestions for building and improving drug regulatory system in our country. The strategy includes two major aspects: First, macroscopically put forward the basic considerations for building our drug regulatory system; Second, microscopically describe the specific strategies for establishing our drug regulatory system from the perspective of multi-dimension and full-spectrum, including establishment of new organization structure for drug regulatory processes, development of strict and controlled decision-making algorithm, improvement of legal and regulatory system, creation of highly efficient and connected supporting system for registration data, and establishment of scientific and standard technical evaluation system for registration administration. |
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