The number of national drug review experts is less than 1/20 of the United States

Business Club March 7th The application of medical technology involves people's health and life safety, national stability and social progress. Scientific, accurate and timely assessment of the safety and effectiveness of medical technology products is the primary task of ensuring the safety of public diet drugs. Professor Han Zhongchao, a member of the Standing Committee of the Chinese People's Political Consultative Conference and professor of the Institute of Hematology at the Chinese Academy of Medical Sciences, called for participation in this year's National Conference.

According to Han Zhongchao, the "Twelfth Five-Year Plan" has listed biotechnologies including biomedicine and biomedical engineering products as the key supporting industries, which is an important strategy for improving the pharmaceutical industry and the core competitiveness of biotechnology. significance. However, due to various factors such as the organizational structure, policies and regulations, human and financial resources, and review mechanisms in China, there is a large gap between developed countries and developed countries in the review of drug technologies. Specifically, the number of personnel in the evaluation agency is too small; the professional division of labor is not clear, which seriously affects the scientific nature of the review work; the academic support system is weak and systematic biases are prone to occur; the review task cannot be completed in time.

Han Zhongchao analyzed that China, as a large country with a population of 1.4 billion, has a severe shortage of personnel in the field of drug technology review. Data for 2008 show that the total number of personnel in the Center for Drug Evaluation of the State Food and Drug Administration is 120, while counterparts in the United States, the European Union, Japan, and Taiwan are 2632, 530, 521, and 130, respectively, less than the United States. /20. Through simple comparison of the number of personnel, it can be seen that the ratio between the amount of human resources owned by the China Food and Drug Review Center and the number of review tasks is seriously out of balance.

Han Zhongchao believes that the drug technology review work is faced with brand-new drugs, with unknown and high-risk characteristics. It is necessary to carry out professional evaluations from various disciplines such as pharmacy, pharmacology and toxicology, clinical and biological statistics according to relevant procedures. And on this basis, a comprehensive analysis of the benefits of risk, weighing the advantages and disadvantages, and combined with the sample inspection and on-site verification to make the final evaluation and judgment. Due to the lack of multi-discipline and multi-disciplinary personnel in our country, our basic professional division of labor is not clear, and we cannot organize reviews according to scientific principles. Most of the current time and effort of the reviewers are on the "progressive schedule" and "clearance tasks". This may lead to systemic deviations in work due to personal professional knowledge defects or preferences, and it is difficult to follow scientific supervision. The request for a rigorous review will, to a large extent, lead to potential safety risks in the marketed drugs.

In view of the fact that drug safety is related to people's health and life safety, Han Zhongchao appealed on this issue. It is necessary to strengthen the construction of the review mechanism of the State Food and Drug Administration and improve its functions as soon as possible so as to create an innovative management environment for the development of innovative medical technology products.

He suggested that, first of all, it is necessary to greatly increase the staffing of the review center, and at the same time, it should be equipped with adequate facilities and facilities to build a good support system for drug review. To adapt the review to the increasing demands of the people for the high quality, high level and high efficacy of medicines.

In addition, the government should further improve the “Approval Methods for Approval of New Drugs” in the “Drug Administration Law.” For some innovative drugs with independent intellectual property rights and high technical content, there must be specific measures for clinical trial approval and market access. Measures will be advanced.