under the state council office of special researcher former deputy director of the state food and drug administration and party member and a speech
children are the future of our motherland, but in terms of child safety administration, but there are still various problems in our country. On December 17, & other; 2017 children safe drug innovation development peak BBS & throughout; Site, the office of special researcher of the state council, former deputy director of the state food and drug administration and a truth, current misunderstanding between two children’s drugs: & other; Basic guess usage, dosage of basic by snapping & throughout; .
children as miniature adults can never be
in clinic, to solve the problem of children’s drugs lack, may choose the related adult medicine break pieces processing, etc. But in fact change of the development of children of different age stages of drug effect and drug doses have great influence. On medication, children can not be regarded as miniature adults, children have their unique disease type, dose, and developmental stage.
Beijing children’s hospital affiliated to the capital university of medical sciences, medicine, children’s safety, director of the department of medicine branch executive President xiao-ling wang director also revealed that the current serious shortage of information leaflet in children’s drugs, paediatric medication guide, lack of standard, evidence-based basis is insufficient, lead to exceed manual medicine pediatrics phenomenon is widespread, not rational drug use and drug risk is significantly higher than adults. At the same time, suitable for young children’s types and specifications are obviously inadequate.
the national health department deputy director of the family planning policy and basic drugs system Zhang Feng pointed out that with the increase of medical and health system reform forward, children’s basic medical conditions improved significantly, children’s health and medical level gradually improve, but still there is a lack of appropriate dosage forms specifications childfriendly medicine, manual medicine for children lack of information, compared to children’s drug problems such as less developed countries. In terms of root cause, relative to adults or children’s drugs and drug co., LTD., research and development production cost is high, clinical trials is difficult, enterprises lack enthusiasm, etc.
Zhang Feng introduction, national health development planning commission aimed at the problem of children’s drugs, also done a lot of work, such as in 2017 has just introduced the new national health insurance directory, added 91 children’s medicine varieties, and the list of drugs specifically applicable to children’s medicines or dosage to about 540.
& other; We have also recently had just solved the children leukaemia life-saving medicine mercaptopurine piece out of stock problem & throughout; , said Zhang Feng similar mercaptopurine life-saving drugs, orphan drug problem have been media reports in recent years, concern for the masses, but & other; Mercaptopurine pricing just a few dollars. To use or want to rely on break, if you don’t want to break, manufacturers to produce different dosage forms, the current pricing, (manufacturers) do not collect their cost & throughout; .
Europe and the United States to pass legislation to promote children’s drug research and development of supply
jing Chen, a researcher at Peking University health science, points out that children’s drugs lack in Europe and the United States is also a problem of concern, but the United States and the European Union have to explore, through legislation to promote children’s medicine research and development and supply, improve children’s health.
pheasant researcher thinks, Europe and the United States legislation experience for reference in China: (1) to pass legislation to promote children’s drug research and development and supply; (2) children’s special regulatory philosophy. (3) combined incentives and compulsory. The United States and the European Union established a priority review, monopoly protection and financial policy support and a series of incentives. In new drug applications at the same time required to provide the safety and efficacy of pediatric group evaluation data; (4) specialized institutional review. The United States and the European Union are the review mechanism, set up a special children’s drugs is conducive to strengthening the protection of pediatric clinical trials of ethics, medicine for children to improve the efficiency and quality of the review.
solve the problem of children’s drugs, traditional Chinese medicine can’t pause
according to the latest release of the 2016 white paper on children’s medication safety report shows that children in our country adverse drug reaction rate is twice the adult, newborn was four times, and our children, drug is less than two percent. While pediatricians loss of talent team, also add fuel to the drug in another degree.
national respiratory disease clinical research center director, director of the Beijing children’s hospital respiratory ShenKun ling introduces, at present the national children’s hospital number is 79, only 0.35% of the total number of hospital; The constituents of the branch of medical practitioners in the whole country, pediatric medical practitioners only account for 3.9% of the physicians category; Pediatrician amount per one thousand is 0.43 per 1000 children (doesn’t even have half a pediatrician); If the reference to the United States the proportion of 1.46 per 1000 children a pediatrician, the shortage of our pediatrician at least more than 200000.
, director of the institute of botany, Chinese academy of medical sciences drugs xiao-bo sun admitted that child safety of drug use is not only an industry, but a relationship to our future generations can healthy growth. In his view, to do a good job in our country children safe drug use the event, Chinese medicine can never & other; Stay put & throughout; , traditional medicine has one thousand years of experience in pediatric medicine, many classical prescriptions now is still the first choice for the treatment of related diseases in children, curative effect is remarkable.
adult data extrapolation for children’s drugs or
drug for children of all sorts of problems, the state food and drug administration of management review centralized medicine clinical zhi-min Yang, a minister, adult medication data extrapolation to pediatric populations may be a good solution.
with adult medication data extrapolation to the pediatric population, not only can encourage development of pediatric drugs, reduce unnecessary pediatric research, also can minimize the number of participants in pediatric clinical trials, maximum use of existing data, through the data extrapolation pediatric drug information, to improve and enrich children to guide clinical drug use.
he suggested priority pediatric population in our country need, clinical widely use, and that adults are on the market in China and abroad in pediatric population has approved indications of medicines for extrapolation; Encourage generic listed abroad, widely used in the study on extrapolation of pediatric drugs. Child safety medication branch recently will assist in the evaluation center, to carry out the adult dosage data extrapolation to technical guiding principles of pediatric population policy, encourage enterprises to conform to the existing standard of adult medicine extrapolation to the child medicine research and development project, make more children’s drugs as soon as possible, solve the problem of accessibility of children’s drugs.
this BBS, child safety drug branch of medical news and information association of China, Beijing children’s hospital affiliated to the capital university of medical sciences, Beijing tiantan hospital affiliated to the capital university of medical sciences, jointly organized, the sunflower pharmaceutical group pharmaceutical co., LTD., Beijing RenTang pharmaceutical technology development co., LTD., xi ‘an lm pharmaceutical co., LTD., shijiazhuang longtzer pharmaceutical co., LTD., Beijing Wan Sheng pharmaceutical co., LTD., neck convalescent pharmaceutical group co., LTD., guangdong dint group pharmaceutical co., LTD., tianjin pharmaceutical co., LTD. Jointly undertake to recognize.
China medical news information association child safety administration branch was formally established
on December 17, Chinese medicine news and information association child safety administration branch was formally established, Beijing tiantan hospital affiliated to the capital university of medical sciences, frank zhao, director of the department as a child safety use branch of medicine, national respiratory disease clinical research center director, director of the Beijing children’s hospital respiratory ShenKun ling served as President of child safety drug branch of medicine.
it is understood that China medical news information association child safety administration branch is made up of pediatric medicine, pharmacy, in the field of Chinese medicine and health care insurance and news agencies and experts composed of voluntary national, professional, non-profit social organization. Chapter is the main task of the organization to carry out the children’s safety medical popular science propaganda and policy, to promote international medical exchange platform structures, promote children’s medication safety specification management and rational drug use.
and also pointed out in his speech, the establishment of child safety administration branch, should serve as the bridge between government, hospitals, between enterprises, strive for policy support, to work, do the work, do a solid, as the voice of enterprises, for the social service, to ensure the safety of our country medicine for children of accessibility.