Bi Jingquan: there are many potential risks in drug quality and safety in China

[expert opinion of China Pharmaceutical network] according to the drug management work of bijingquan report, at present, the low-level repetitive problems in the pharmaceutical industry are more prominent, there are more potential risks of drug quality and safety, the contradictions in the field of drug circulation are complex, and the mechanism of shortage drug supply guarantee needs to be improved These problems are analyzed in detail in the report (Bi Jingquan: many pictures of potential risks of drug quality and safety in China source: Baidu pictures) on the morning of June 22, the 28th meeting of the Standing Committee of the 12th National People's Congress was held in Beijing Bi Jingquan, director of the State Food and drug administration, made a report on drug administration by the State Council According to the report, significant progress has been made in drug management in terms of regulatory system construction, R & D and registration management, production and circulation supervision According to the requirements of the drug administration law, all regions and relevant departments continue to improve the drug regulatory laws and policies, strengthen the management of the whole process of drug R & D, production, circulation and use, improve the quality of drug use by the people, and basically solve the problem of drug accessibility The reform of drug review and approval system has also achieved results In August 2015, the State Council issued the opinions on reforming the review and approval system of medical devices (GF [2015] No 44) The reform has progressed smoothly At present, the backlog of drug registration applications has been basically eliminated, and the quality of drug clinical research and the transparency of review and approval have also been improved The report also highlights the main problems still existing in the current drug management work: first, the low-level duplication problem in the pharmaceutical industry is prominent in the era of lack of medicine, the main task is to solve the problem of insufficient quantity of drugs, and the drug listing standard is relatively low; before 2000, the drugs were approved by the provinces (districts, cities), and the standards are not unified The investment in drug R & D is seriously insufficient In 2016, the investment in R & D of national pharmaceutical enterprises was less than that of one of the largest pharmaceutical enterprises in the world There is a shortage of innovative drugs urgently needed in clinic, and structural problems are prominent 2 There are many potential risks in drug quality and safety, especially for injection made from traditional Chinese medicine approved for marketing in the early stage The basic research on safety and effectiveness is weak Part of the production enterprises cut down materials, use fake raw materials and change production process without authorization, which seriously affects the safety and effectiveness of drugs There are hidden quality and safety risks in winning the bid at low price There is a big gap among pharmaceutical technicians, licensed pharmacists and clinical pharmacists Drug recycling and resale often occur 3 There are about 12900 existing drug wholesale enterprises with complex contradictions in the field of drug circulation, and the problems of "small, scattered and disorderly" are prominent The purchase and sale records of some pharmaceutical logistics and distribution enterprises are untrue and incomplete, and the illegal business activities such as fictitious flow direction, separation of tickets and goods, and affiliation and walking tickets are not allowed for many times Some licensed pharmacists practice under the name of registered pharmacists, and illegal behaviors such as prescription drugs not sold according to the prescription, and drugs stored in violation of GSP are common The system of "medical support by drugs" has not been completely broken, and the unhealthy trend in the field of drug purchase and sale and medical treatment still exists 4 The mechanism for ensuring the supply of drugs in short supply needs to be improved to ensure the coexistence of total overcapacity and structural shortage of drugs Some enterprises monopolize the raw materials of some drugs in an improper way, reduce or stop production and sales at will, and drive the price soaring The report also makes an in-depth analysis of the causes of the above problems: first, the system and policies to encourage drug innovation are not perfect; second, the drug management law cannot fully meet the development needs; third, the drug regulatory capacity cannot meet the needs of industrial development; fourth, the reform of the medical and health system needs to be further deepened.