How to break the "system bottleneck" of domestic new drugs?

Source: on September 19, 2016, science and Technology Daily recently returned to China to contact with many friends in the biomedical industry It was found that there are some problems in the field of medicine and health that need to be solved as soon as possible, especially the urgent need to strengthen the practical functions of the State Food and Drug Administration (CFDA) In order to solve the "bottleneck" problem in the production of domestic new drugs, I suggest deepening the reform and Comprehensively Strengthening the practical functions of CFDA In recent years, the state has invested a lot of funds in the field of basic biology and clinical medicine through the Ministry of science and technology and the health and Family Planning Commission in the form of major new drug innovation projects One of the main goals is to reverse the current situation that our country relies heavily on imported drugs in the treatment of major diseases, gradually develop and establish China's own national pharmaceutical industry, produce new drugs with independent intellectual property rights, and complete the requirements of China's major strategy towards an innovative country in the field of Medicine and health At the same time, through scientific and technological innovation, we will gradually solve the major livelihood problems of "taking imported drugs, expensive medical treatment" I'm encouraged by the country's increased investment in the "upstream" of new drug research and development However, as a whole, the situation of independent research and development of new drugs is not optimistic One of the main reasons is that the role and function of national food and drug supervision and management is far from meeting and adapting to the current national strategic needs There are three main problems: first of all, in the approval and supervision of essential clinical trial applications in the process of new drug development, the State Food and drug administration should change the current working mode and policy, from administrative approval to the form of "Filing" In western countries, pharmaceutical companies and relevant scientific research and medical institutions that apply for clinical trials are fully responsible for the authenticity and accuracy of their applications The responsibility of the drug regulatory bureau is to file on the basis of the applications, and to review, approve and monitor the project at the same time Once there is a problem, FDA can order relevant clinical trials to be modified or even stopped according to the actual situation The current system of China's food and drug administration is that the project approver of CFDA is responsible for the authenticity and accuracy of the clinical trial application, on the one hand, it excessively reduces the requirements of the application related units; on the other hand, it greatly slows down the approval process because the staff of CFDA assume unnecessary responsibilities In the United States, clinical trials submitted to the FDA are usually answered within 30 days, while in China it is now often a year or more The low efficiency of the drug approval will make many promising new drug development miss the good opportunity, or force pharmaceutical factories or research institutions to transfer to foreign development In order to change this situation, it is suggested that the relevant departments should refer to the "Filing" system which has been implemented in Europe and the United States for many years and has been proved effective by practice, that is, the applicant should take the main responsibility for clinical trials, and completely change the current situation that the approval of CFDA has become a "bottleneck" in the process of new drug development Second, the number and level of knowledge of the staff engaged in the approval and supervision of new drugs in China are greatly deficient, which needs to be changed urgently By contrast, the FDA has tens of thousands of staff, more than half of whom have doctorates However, there are only hundreds of people in China, a large part of them are old-fashioned, unable to connect with the basic research and Transformation Research of modern biomedicine Taking stem cell therapy as an example, China's basic and transformation research in this field has reached the world-class level in some aspects, but if there is no corresponding and effective supervision to ensure that China's scientific research and medical personnel meet international standards The implementation of this new treatment method will be difficult to get international recognition, and then it will be limited in patent application and other aspects Our advantages in this area may be lost soon In order to solve this urgent problem, it is suggested that the relevant departments give priority to increasing the establishment of the State Food and drug administration by a large margin as soon as possible, and recruit the urgently needed professionals with higher academic qualifications in the evaluation and supervision of drugs and medical devices At the same time, we should establish a new evaluation system with "third party" as the main body, referring to the consistent practice of European and American countries in approving new drugs The State Food and drug administration may set up special committees according to the main types of human diseases, such as tumors, cardiovascular and cerebrovascular diseases, nervous system, metabolic diseases and infectious diseases, which are composed of clinical experts, researchers of basic and translational medicine, R & D personnel of pharmaceutical industry, government supervision and market management personnel, and representatives of patients with diseases After the review of specific new drug approval applications, the expert committee voted to submit its recommendations to the State Food and drug administration as the scientific basis for final administrative approval The members of the expert committee shall have clear legal responsibilities and obligations, implement regular rotation system, sign confidentiality and avoid conflict of interest agreements, etc., so as to ensure the fairness of the review process Once established, these expert committees can first assist CFDA to sort out the current backlog of tens of thousands of applications and deal with them as soon as possible in different categories to solve the current "bottleneck" problem Under the new management mechanism, it is necessary to distinguish the approval of new drugs from the acceptance of applications for modifying the dosage form and expanding the use of listed drugs, because the approval and supervision of listed drugs should be highly simplified, including the direct acceptance of such applications by the provincial food and drug administration Third, the evaluation and supervision of drugs and medical devices are closely related to clinical application, so most developed countries and developing countries put the drug administration under the jurisdiction of the Ministry of health Based on the actual situation in China, it is suggested to establish a special office to be responsible for the evaluation, approval and supervision of drugs and medical devices