Re: the proportion of children's specific drugs in China is less than 2%.
Why are there so few children's special medicines? Bian Zhenjia, a special researcher of the State Council Counselor's office, said: first, the policy is not matched, and the relevant system of supervision and use lacks cohesion. The examination and approval of drug use for children is in the food and drug administration department, the policy management is in the health department, the clinical use is in the medical institution, the reserve management is in the Department of industry and credit, and the relevant systems and standards are not matched, ununified and disjointed. Two, the risk of clinical trial process is large, affecting the clinical development of new drugs. This is also an international problem that plagued children's pharmaceutical production. In developed countries, the premise of clinical trials is to sign informed consent with volunteers, to insure unwanted insurance and the necessary economic compensation for them, and to develop the biggest expenditure is here. Three, the market level of child medication is not high, the profit of pharmaceutical enterprises is low, and the enthusiasm of production is not high. At present, the number of children in China, the amount of drugs used annually is generally stable, and the size of the drug market for children is not large. Children are not the reduced version of the adult, the immature organs, the characteristics, the process, the absorption mechanism and the compliance of the drugs, and the special formulation, preparation and taste. Many production processes and high costs lead to enterprises unwilling to engage in R & D, production and marketing of children's specific drugs.
data from the China Medical Industry Information Center shows that there are 8812 pharmaceutical manufacturing enterprises nationwide, of which only 0.1% of the enterprises specializing in the production of children are specialized in the production of children. In the registration of pharmaceutical clinical trials, there were 165151 domestic drug registration information, of which only 2698 were children's medicines, accounting for only 1.63%. Only 2.35% of children's drugs registered in clinical trials are relatively small compared with 20% of developed countries such as the United States. "
" because the pricing principle of children's drugs is based on the number of effective components of drugs, the content of effective components in children is much lower than that of adult drugs, the corresponding price is lower than that of adult drugs, which makes the price of children's drugs have no obvious advantages, and the enterprises can not get compensation. " Chen Baohua, general manager of Zhejiang Huahai pharmaceutical Limited by Share Ltd, said that to solve the problem of the shortage of children's drugs, it can be summed up by experts from professional associations to summarize the current situation of epidemiology and the current situation of drug use in children at home and to determine which paediatric diseases are in need of drugs urgently, and according to the domestic and foreign guidelines for pediatric drugs and clinical experience. We should formulate a list of children's medicines to encourage research and development, and give priority to review and approval, and guide enterprises to research and develop drugs.
in addition, related experts found in the study that domestic children's drug instructions are generally lack of pharmacokinetic data, even if there are many foreign children's data. In some domestic drug manuals, children's clinical trial data basically copied the original drug instructions. Relevant experts say there are differences in the data between children and adults and children in different countries, and the clinical data of Chinese children should be needed to make the efficacy more accurate, but the clinical data in our country are far from enough.
encourage the development of children's medicine
"in order to protect children's health rights and interests, encourage children to develop drugs. In recent years, various departments have formulated policies on child medication support. " Zhang Feng, deputy director of the State Health Planning Commission, said that since last year, the Health Planning Commission, the Ministry of education and the General Administration of the food and Drug Administration announced the two batch of drugs to encourage research and application of children, including 71 varieties, and made clear the special channels for the application of drugs in the "list", which had been used for years and clinical treatment in Hong Kong, Macao and Taiwan. Children who have been effective and safe, but not listed in the mainland are in urgent need of drugs, explore the use of pilot imports, and allow direct reference to the data of children's clinical drug use in Hong Kong, Macao and Taiwan as a declaration basis in the registration and review of imported children's medicines, and to speed up the review and approval. In addition, through the national "major new drug creation" major science and technology major, protein biologic drugs and vaccine major innovation and development projects, integrated advantage units to cooperate with innovative research and development, guide and encourage enterprises to give priority to R & D production; in the protection of production supply, the corresponding policy support for the production of drug production enterprises for children is promoted. To carry out the upgrading of the product and the technological transformation of the production line.
Wang Tianyou, Secretary of the Party committee of Beijing Children's Hospital, said that the clinical trials of children's drug use are faced with difficulties in evaluation, high risk assessment, difficult recruitment of subjects and lack of professionals. Beijing Children's Hospital will unite many units during the period of "13th Five-Year" to further strengthen the construction of the supporting system for the clinical evaluation of children's demonstration drugs, through the construction of the key technical platform for the optimization design of the clinical trial of children's drug clinical trials and the construction of the key technical platform for the clinical evaluation of the large data of the children's drug data, to improve the clinical evaluation of the drug for children. Ability. 3 clinical specialties were selected as the representative of children's common diseases, children's major diseases and children's rare diseases, and a demonstration platform for the clinical evaluation of children's new drugs was set up.
at the same time, Ceng Yixin, deputy director of the National Health Planning Commission, said that the six departments, such as the National Health Planning Commission, have issued several opinions to guarantee the use of drugs for children and set up the two batch of encouragement and development lists. Especially in the national major projects for the development of new drugs, the research and development of children's drugs and the accelerated examination and approval have been the key tasks. "The medicines for children should have the appropriate dose according to the weight of different children; the dosage form should be taken by oral liquid; and it should be suitable for children's taste and let the child be willing to drink. This is the key task of '13th Five-Year'. The Ministry of science and technology, the Ministry of finance, the General Administration of food and Drug Administration and the Health Planning Commission jointly accelerate the research and development and examination and approval procedures suitable for Chinese children. It is estimated that the shortage of children's medicines will be effectively resolved in a few years. "
"the healthy growth of children is related to the harmony and happiness of every family and the progress of national health and sustainable development." Zhang Feng said that the problem of safe use of drugs for children needs to be mobilized to give full play to their respective functional advantages, including government organs, social organizations, enterprises, hospitals, media and so on. At the same time, it should also carry out the dissemination and education of the knowledge of scientific medicine for children.