Antibiotics used in China should be studied in the study of "human differences/bacterial differences"

"The differences in ethrax/species may affect the safety, effectiveness, dosage and administration of the drug, limiting the acceptance of data for clinical trials abroad in new areas.
the current clinical use of antibiotics in China (including imported) have not been completed in China and the results of drug sensitivity tests have not been released, much less approved by the China Drug Administration.
"global drug resistance is severe, antibiotic research and development and rational application of increasingly important all drugs will have resistance and tolerance problems.
the problem of antibiotic resistance is also one of them, anti-drug-resistant infections are rapidly becoming the norm, multi-drug-resistant bacteria appear in large numbers, seriously threatening human health.
G20 Hangzhou summit, the Chinese government pledged to give priority to supporting Chinese companies in developing new drug-resistant antibiotics.
Under the new IPPS antibiotic use program in the U.S. by 2020, the U.S. encourages clinicians to treat patients with new antibiotics first, so that they can be treated within the effective time window, protect life more effectively, shorten treatment time, save treatment costs, and effectively prevent the production of drug-resistant bacteria.
Drug sensitivity test is no longer "once and for all" drug sensitivity test is an important link in the study and application of antibiotic pharmacology, can be used as the basis of drug resistance epidemiological investigation data, can also be extratroted to the body sterilization effect, predict the clinical treatment effect of antimicrobial drugs, in the choice of drug types to help clinicians to implement individualized treatment.
is a new requirement put forward by clinical research on antibiotics in China in recent years.
for approved antibiotics entering China should be supplemented after the fact, especially the use of bacterial strains in the Chinese region for drug sensitivity research.
that no pharmaceutical company, including Pfizer, has completed the study in China.
Drug sensitivity outcomes between different species and strains tend to vary widely when drugs are registered with the FDA and EMA, requiring clinical trial data on ethloymic differences, at least for whites and blacks, and for a minimum percentage of demand.
-species difference is the clinical response of drugs, including ability and safety, with human sensitivity, its metabolic dynamics, pharmacodynamics, safety in different species often show different characteristics, divided into internal and external causes.
in the case of the new coronavirus, there are five variant families.
strains of new coronavirus from different sources have different infectious effects, and with geographical differences, strains or virus species, a treatment option often does not work completely.
In a drug-sensitive trial study of lactic acid bacteria from different sources, the results of 10 commonly used antibiotics showed that differences in source regions were the more important factors affecting the drug sensitivity of strains in different sources and strains.
all antibiotics have not completed all drug-sensitive tests in China, especially in China's regional strains of drug-sensitive tests in recent years, China and Europe and the United States to speed up the approval of new drugs, to stimulate anti-drug-resistant bacteria drug research and development, market.
in the past decade, China has listed a variety of anti-drug antibiotics, including compound antibiotics, and gradually standardized the rational application of antibiotics to cope with clinical resistance.
, none of the antibiotics currently sold in China have completed all drug-sensitive trials in China.
Intransied domestic clinical response to drug-resistant infections commonly used compound antibiotics, the most widely used cephalosporine Shubatan, pyridoxirintambatan and other drugs, its single product in China sold more than 5 billion yuan per year, clinical application is very widespread, but has not yet completed the study of Chinese groups of drug sensitivity, has not issued China's official approval of the drug sensitivity report and the approval of the China Drug Administration.
China is a country of 1.4 billion people, new drugs or generic drugs on the Chinese market will be more widely used in disease prevention and treatment.
actively carry out research on pharmacodynamics, pharmacodynamics and drug safety data collection and analysis in China, which can provide an important guiding role for the people to use all kinds of new drugs safely and effectively.
The Biosecurity Law should actively respond to microbial resistance and bioterrorism, especially monopoly! !️ On October 17, 2020, the 22nd Session of the Standing Committee of the 13th National People's Congress adopted the Biosecurity Law of the People's Republic of China.
Among them, biosecurity refers to the effective prevention and response of the state to the threat of dangerous biological factors and related factors (including superbugs, etc.), biotechnology can be stable and healthy development, people's life and health and ecosystems are relatively free of danger and threats, the biological field has the ability to maintain national security and sustainable development.
The Biosecurity Act requires an active response to microbial bacterial resistance to protect people's lives and health from threats.
to deal with microbial resistance, China should encourage the development and application of new antibiotics, especially anti-superbug resistant antibiotics, strengthen drug quality management, and improve clinical application guidance.
At the same time, clinical drugs should be prevented from being monopolized by foreign enterprises, in case of a situation, to encourage the use of more affordable domestic drugs to replace U.S. drugs in China, such as domestic I. class (including 1.1 to 1.6 classes) innovative drugs and first generic drugs, but also should be supported, into the Chinese medical insurance directory, in order to ensure the safety of China's pharmaceutical medical supply chain, to protect people's health and safety and national security.
: s1. Evslyn B, Toigo T, Bauls D, et al. Participation of racial / ethnic groups in clinical trials and race-related labeling. A review of new molecular entities approval. 1995-1999. J Nal Med Assoc , 2001, 93 (12): Supplement. International Association for technical requirements for the registration of human medicines, ICH-E5 (R1) - Racial factors in the acceptability of clinical data abroad - 19980205. Li Wei. The Importance of participation of people of all ethnic groups in clinical trials. Journal of Drug Epidemiology, 2002, 11 (3): 122. Zeng Xiaoqun, Pan Daodong, Guo Yuxing, etc. Drug Sensitivity Tests of Lactobacillus from Different Sources, China Food Journal, 2012, 9:179-185. Biosecurity Law of the People's Republic of China