FDA will adopt incentive model to promote the development of new antibiotics

[China Pharmaceutical network industry trends] according to the statistics of the Centers for Disease Control and prevention, at least 2 million people are infected with antibiotic resistant bacteria every year, resulting in 23000 deaths every year Behind these alarming figures, the issue of antimicrobial resistance has also been raised in front of various countries Antimicrobial agents are a kind of drugs used to treat bacterial fungal infection, they can kill or inhibit the growth of bacterial fungi Nowadays, antimicrobial resistance has become a major challenge in the field of global public health It is pointed out that the unreasonable use of antibiotics will aggravate the production and spread of resistant microorganisms The lack of infection prevention and control, the imperfect quality assurance system of antibiotics, the lag of new drug development, the incomplete or not established supervision and inspection system directly or indirectly lead to the increasing trend of antibiotic resistance China is a big country in the production and use of antibiotics, accounting for about half of the world's consumption, 48% of which is for human use, and the rest for agriculture From the perspective of China's situation, in the past, the irrational use and even abuse of antibacterial drugs were very prominent In recent years, the management of antibacterial drugs has become a highly valued issue in China It is reported that as early as 2012, China launched the "Anti Japanese order" and has been upgrading in recent years In August 2016, 14 departments including the national health and Family Planning Commission jointly formulated and published the national action plan to curb bacterial drug resistance (2016-2020), which officially opened the prelude to the action to curb antimicrobial drug resistance in China On April 21 this year, the national health and Health Commission issued the key points of the core system of medical quality and safety, including 18 core systems, including the hierarchical management system of antibiotics In May 2018, the national health and Health Commission issued the notice on continuing to do a good job in the management of clinical application of antibacterial drugs, emphasizing further strengthening the management of clinical application of antibacterial drugs, and once again upgrading and restricting the use of antibiotics According to the statistics of 2017 national medical service and quality safety report, the utilization rate of antibacterial drugs in the consultation decreased from 19.4% in 2010 to 7.7% in 2017 The use rate of antibiotics in inpatients decreased from 67.3% in 2010 to 36.8% in 2017 In general, through the efforts of various departments and the popularization of knowledge of antibacterial drugs, the abuse of antibacterial drugs in China has been greatly improved and the overall trend is stable At the kick-off meeting of this week, Zhang Zongjiu, director of the medical administration bureau of the national health and Health Commission, pointed out that at present, the social governance system to curb bacterial drug resistance has been gradually formed in China, the rationalization level of the use of antimicrobial drugs has been continuously improved, and the overall situation of bacterial drug resistance is stable and good In addition, according to the report on China's antimicrobial management and bacterial resistance (2018), the construction of bacterial resistance monitoring system in China is gradually developing and improving It can be seen that the level of rational use of antibiotics in China has been greatly improved, and there is still a long way to go in the construction of monitoring system It is reported that the FDA has been looking for new solutions from all aspects The first is to ensure that antibiotics are well regulated and used under reasonable clinical conditions Second, it will promote the development of new antibiotics, for example, based on the consideration of economic environment and drug use, to adopt a new incentive model for researchers The industry believes that the rational use of antibiotics requires the public to strengthen the understanding of antibiotic drugs, and in the aspect of antibiotic development, because the project needs certain research and development investment, and needs to take greater risks, it needs the support of relevant policies.