Month: September 2022

“Divide one adult standard tablet into 1/2 tablets, 1/4 tablets, or even 1/8 tablets, which is a children’s tablet.” This common misunderstanding of pediatric medication-“children are young adults” actually reflects the reality of “shortage of children’s medicine” in China. According to the statistics of the National Federation of Industry and Commerce Pharmaceutical Chamber of Commerce, there are about 6,000 pharmaceutical enterprises in China, and only 10 pharmaceutical enterprises specialize in the production of children’s medication. In addition, 90% of drugs in our country do not have “children’s version”. In september 2016, the white paper on the investigation report on children’s drug safety in 2016 released by the southern institute of medicine and economics of the state administration of supervise and management on food and drug showed that there were about 30000 deaf children in china every year due to improper medication. Among the children Group, the proportion of drug poisoning in all poisoned children increased from 53% in 2012 to 73% in 2014. “Children have their growth and development rules and physiological and pathological characteristics, and have their particularity in the occurrence, development and prognosis of diseases. Even if children and adults get the same disease, its development rules are different, and the prescription selection, precautions and medication rules are also different.” Li Lianda, an academician of Chinese Academy of Engineering and a expert in pharmacology of traditional Chinese medicine, said in an interview with the media before, “it is wrong to think that children’s medicine is the medicine of Internal Medicine, which is half and reduced.” This situation is expected to be alleviated. On May 12, the State Health Planning Commission announced the second batch of recommendations for encouraging research and development to declare children’s drugs. 40 drugs including erythromycin and omeprazole were not registered and listed in mainland China, and children’s drugs urgently needed in clinic are “on the list”. The reporter of surging News (www.thepaper.cn) noticed that, including the first 32 varieties of public cloth in June 2016, 72 varieties of children’s drugs have entered the list of encouraging declaration, covering the treatment of nerves, cardiovascular diseases, common diseases of endocrine, blood and other systems. The person in charge of the relevant departments of the National Health Planning Commission stated that the formulation of the list was intended to guide the research and development of children’s drugs. Different from adult drugs, enterprises had little interest in developing children’s drugs in the past, and the obstacles mainly lie in clinical use and input and output of research and development. Guan Yanbin, chairman of the Sunflower Pharmaceutical Industry, who has been deeply engaged in the children’s medicine market for 10 years, once told the media that from the perspective of clinical trials, almost no parents are willing to let their children bear the risks of clinical trials. In terms of output, the R & D investment of the two is equivalent, but the profit of children’s medicine is far lower than that of adult medicine. Under multiple backgrounds, it is of far-reaching significance to sort out the specifications of suitable drug dosage forms for children that have been listed abroad but have not yet been registered in China, and formulate the “list of drugs for encouraging research and development to declare for children. The relevant person in charge of the National Health Planning Commission stated that for enterprises, it will help enterprises adjust the production layout reasonably and avoid the blindness of research and development; For medical institutions and medical personnel, it will partially alleviate the dilemma of the hospital, improve the current situation of insufficient clinical medication, gradually meet the clinical needs of Pediatrics, scientifically grasp the dosage of medication, further improve the level of rational drug use for children, and improve the quality of medical services; For children and parents, increase appropriate dosage forms and specifications to greatly reduce medication risks and promote clinical medication safety. This may also indicate the next outlet for domestic pharmaceutical companies. At present, there are about 0.22 billion children in the country, and the drug market for children is huge. Favorable policies are coming frequently. For example, on May 12, the State Administration of Food and Drug Administration announced the relevant policies on encouraging the innovation of drugs and medical devices to protect the rights and interests of innovators (draft for comments), proposing that drugs for both innovative drugs and rare diseases, for children special purpose chemicals, a 10-year data protection period will be given. For rare disease drugs and children special purpose chemicals that belong to modified new drugs, a 3-year data protection period will be given. 1413 “divide an adult standard tablet into 1/2 tablets, 1/4 tablets, or even 1/8 tablets, which is a children’s tablet.” This common misunderstanding of pediatric medication-“children are young adults” actually reflects the reality of “shortage of children’s medicine” in China.

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