According to the results of the sixth census, China's population aged 0-14 is 16.6% of the total population, and the number of pediatric patients accounts for about 20% of all patients. However, for a long time, due to the shortage of children's special medicines, many children are treated as “reduced versions of adults†when taking medicine. According to the principle of “children's discretionâ€, there is a huge risk of medication safety.
"The amount is basically based on guessing, the usage is basically relying on 掰", this is the status quo of the majority of children's drugs in China. Not to mention the parents of ordinary children, the doctors who prescribe drugs, or even the professional pharmacists in the hospital. In the face of the instructions and requirements of the "children's discretion" on the drug label, they have no confidence in their hearts. Correspondingly, it is the health threat and security risks brought to the millions of children in the country by “drugs are as good as tigersâ€. According to the national monitoring results of adverse drug reactions, the incidence of adverse drug reactions in children in China is 12.9%, including 24.4% of newborns, which are twice and 4 times that of adults. Due to improper medication, about 30,000 children are deaf and 7,000 children die each year in China.
So what exactly limits the emergence of child-specific drugs in the market? According to data from the China Pharmaceutical Industry Information Center, there are more than 8,000 pharmaceutical manufacturers in the country, of which only 0.1% are specialized in the production of children's drugs, that is, only 8 are produced for children. In the drug clinical trial registration project, the registration information of domestic drugs reached more than 160,000, of which only 2,000 children's drugs accounted for only one-eighth of them.
In the view of pharmaceutical manufacturers, the indicators of children's medicines are more stringent than those of adult medicines. The dosage forms are more demanding than adult medicines, and the requirements in all aspects are more stringent. Children's drug clinical trials are risky, and the age range is narrow, and the taste needs special adjustment, which increases the production and R&D costs of the enterprise. In other words, the rules and regulations that were originally intended to better protect children's medication safety and better protect the interests of the people have objectively led to the contempt of pharmaceutical manufacturers for children's medication.
In this case, in order to solve the safety problem of children's medication, and encourage pharmaceutical manufacturers to launch special children's medicine dosage forms, it is mainly necessary to start from two aspects. First, through the encouragement and guidance of policies, the role of market regulation, such as the development of children's drugs from research and development, clinical experiments to production, has opened a "green channel", giving policy inclination, reducing production and operating costs, encouraging enterprises to develop and produce specialized Children's medication.
The second is to give children a "security lock" through the legal level. Although policy incentives at the national level have continued in recent years, child drug legislation has not yet been achieved. In China's two most important drug laws and regulations, the Drug Administration Law and the Drug Registration Regulations, no special provisions are made for the use of children's drugs or adult drugs, and there is no institution that regulates children's drugs. Therefore, how to pass the legislation and standardize the evaluation of children's medication experts as soon as possible, issue scientific and standardized guidelines for children's medications, and regularly update and standardize the prescription behaviors of physicians and children, so as to improve the level of scientific diagnosis and treatment and rational drug use, and establish a national unified and authoritative synthesis of children's clinical drugs. The evaluation system and clinical database are the top priorities for ensuring the safety of children's medication. â– Court is vast
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