In 2021, a total of 47 children's drugs were approved for marketing in China, of which 14 were included in the priority review and approval, which promoted the marketing process of children's drugs and significantly improved the level of children's clinical medication. At present, more children's drug use is in the process of application, and the problem of children's drug use in China will be further improved. The new version of the national medical insurance drug catalogue will be officially implemented on March 1, 2023. The total number of drugs in the adjusted national medical insurance drug catalog reached 2967, and the new drugs covered 22 children's drugs. The body of children is still in the stage of growth and development, and the organ development is still incomplete. Their liver and kidney functions are significantly different from those of adults in terms of drug metabolism and adverse reaction tolerance. Children's medication refers to a class of drugs that are suitable for the special physique and needs of minors under the age of 14. The Notice on Further Strengthening the Management of Children's Clinical Drug Use (hereinafter referred to as the Notice) issued by the National Health and Health Commission recently proposed that when selecting drugs for children (only those drugs with clear indications for children and dosage for children in the drug instructions), the scope of drug use for children can be further expanded without the restriction of "one product, two regulations" and the total number of drugs. The Notice also pointed out that medical institutions should accurately dispense drugs for children according to the prescription dose, especially for the dispensing of drugs for young children, encourage the development of new technologies and methods that can flexibly adjust the dose, strengthen the standardized management and quality control of personalized drug administration, and reduce the inaccurate and unsafe problems caused by "guess the dose and break the drug". The main data of the seventh national population census released in 2021 shows that the population of children aged 0-14 years in China is 253.38 million, accounting for 17.95% of the total population. According to the 2021 China Health Statistics Yearbook, the number of pediatric outpatients in China's general hospitals will be 230 million in 2020. Although the proportion of the population is not small and there are many children patients, compared with adult drugs, the research on children's drug use still faces the dilemma of late start, great difficulty and weak foundation. At present, there are few kinds of drugs for children in China. Chen Ruijie, director of the pharmacy department of the Second Affiliated Hospital of Wenzhou Medical University and Yuying Children's Hospital, said that the drugs for children in China are mainly used in the respiratory system and digestive system. In addition, granules, tablets and oral solutions are mainly used, while inhalers, chewing agents and patches are more suitable for children. The data shows that the market shares of respiratory system drugs, digestive system drugs, anti-infective drugs and nutritional supplements in China's children's drug market are 39.2%, 20.5%, 17.6% and 15.8% respectively, and there are few special drugs for tumor diseases, cardiovascular diseases, nervous system diseases, etc. Since 2011, China has issued a number of favorable policies to encourage and support the development and production of drugs for children. The newly revised Drug Administration Law of the People's Republic of China in 2019 clearly supports the development of new varieties, dosage forms and specifications of drugs for children that meet the physiological characteristics of children, and gives priority to the review and approval of drugs for children. The State Food and Drug Administration has opened a green channel for children's drug use
Edit：Ying Ying Responsible editor：Shen Chen
Source：digitalpaper.stdaily.com
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