In recent years, China s children s medicines have been subject to restrictions from both research and development and the market, while facing many problems such as shortage. With the implementation of the comprehensive two-child policy, the proportion of the child population will increase year by year, and the plight of drug use will further increase.
It is imminent to crack the difficulty of children s medication in China and regulate the medication of children. Some experts have called for the need to incentivize the R \\ u0026 D and production of pharmaceutical companies through various methods such as intellectual property protection, accelerated drug approval, and the establishment of financial funds to break the difficult situation of children s difficulty in using drugs as soon as possible.
According to statistics, among the 170,000 drug approvals in China, there are only about 3,000 children-specific drugs; there are about 3500 types of preparations commonly used in hospitals in China, of which only about 60 are child-specific varieties; and among the the 520 basic drug catalogs, there are children-specific varieties. Only 2 types. The dosage forms and specifications of children s medications are also extremely single. A survey by Beijing Children s Hospital showed that the top three of the 231 children s prescription drugs in 15 tertiary medical institutions nationwide are injections, tablets and oral solutions, such as powder inhalers, syrups, drops And aerosol varieties are very limited.
Although the children s medicine market is vast, for pharmaceutical companies, the development and production of children s medicines face the problems of long cycles, high costs, thin profits, and high requirements for R \\ u0026 D and production. Chen Baohua, general manager of Zhejiang Huahai Pharmaceutical Co., Ltd. introduced that the production characteristics of children s medicines are small batches, multiple batches, and relatively complicated processes, which lead to children s medicines not having less investment in production equipment, quality control , and technical investment than adult medicines., And even some aspects of higher investment. However, because the current pricing principle of children s medicine is based on the content of the active ingredient in the medicine, and the content of the active ingredient in the children s medicine is far lower than that of the adult medicine, the corresponding selling price is lower than that of the adult medicine, which makes t he pricing of children s medicine not obvious. Advantages, companies cannot get compensation.
Chen Baohua suggested that China could learn from the relevant practices in the United States and give children medicines a one-year increase in market protection period, 50% tax relief and other preferential policies. At the same time, national and local governments should set up special funds to encourage scientific research institutes and manufacturing enterprises to participate in the development of children s medicines; set up professional institutions to review and approve children s medicines; experts from professional associations summarize the epidemiological status and the current domestic drug use status in children, and determine Which pediatric diseases lack drugs urgently need to be overcome, and based on domestic and foreign pediatric medication guidelines and clinical experience, formulate a catalog of children s medication that encourages research and development, implement priority review and approval, and guide corporate research and development.
Ding Lieming, Chairman of Betta Pharmaceuticals Co., Ltd., suggested that special adverse drug reaction monitoring for children s medicines should be carried out nationwide, and key monitoring products for children s commonly used drugs should be regularly determined, monitoring results should be publicized, and safety data of children s commonly used drugs should be improved for clinical judgment Provide evidence for children s medication risks. At the same time, children s medical insurance policy is constantly improved, and children s commonly used medicines as well as special, effective and expensive rare disease medicines are included in the children s medical insurance catalog and updated once a year. In addition, the establishment of a database of children s clinical trial data and drug information for new drugs can avoid unnecessary duplication of research and reduce the difficulty and risk of developing children s drugs.