Children's medicine research and development into a pharmaceutical company production short board
March 25, 2016 Source: Beijing Business Daily
Window._bd_share_config={ "common":{ "bdSnsKey":{ },"bdText":"","bdMini":"2","bdMiniList":false,"bdPic":"","bdStyle":" 0","bdSize":"16"},"share":{ }};with(document)0[(getElementsByTagName('head')[0]||body).appendChild(createElement('script')) .src='http://bdimg.share.baidu.com/static/api/js/share.js?v=89860593.js?cdnversion='+~(-new Date()/36e5)];Guangzhou Wang Laoji Pharmaceutical Co., Ltd. (hereinafter referred to as “Wang Lao Ji Pharmaceuticalâ€), a child-made Chinese patent medicine manufacturer, announced that it will fully enter the children's drug market in 2016 and develop new varieties of pediatric drugs under the premise of safety, effectiveness and quality control.
"With the continuous improvement of the national health awareness, the safety of drug use has been paid more and more attention. It has become another major issue that has entered the public eye after food safety." Wang Laoji Pharmaceutical related person believes that the current child drug safety documents are issued, some The establishment of pediatrics in universities has marked the arrival of the "spring" of pediatric development.
Some research reports predict that the two-child policy officially implemented on January 1, 2016 is expected to bring about 1 million to 2 million newborns per year. The number of newborns in 2018 is expected to exceed 20 million. This figure will directly stimulate children's medicine. Market demand has risen sharply. Beijing Business Daily reporters found that among the A-share listed companies in pharmaceutical companies, only Kangzhi Pharmaceutical was the only one that mainly produced and sold children's medicines. The other 20 listed companies involved both adult and children's medicines. According to public information, there are few varieties of children's medicines on the market, fewer specifications, less dosage forms, and children's safety medications are facing severe tests. At present, more than 90% of the drugs in the domestic market are free of children's dosage forms, and children's special medicines are less than 2%. At the same time, the proportion of irrational drug use is as high as 12%-32%, and the adverse drug reaction rate of children is twice that of adults. Children are the hardest hit areas for safe drug use.
The continuous introduction of favorable policies is attracting many listed companies that do not involve children's medicine to expand in this field. For example, Yuheng Pharmaceutical, which is mainly engaged in adult injections and chemical tablets, announced its entry into the children's health field in 2015. Kangnian Medical, a Hunan development holding subsidiary that specializes in hydropower, set up a company in Changsha in March last year with an investment of 16 million yuan. Child rehabilitation center.
While the demand is increasing, the children's drug market is facing a severe test. Shi Lichen, head of Beijing Dingchen Medical Management Consulting Center, said that although China's children's drug market has broad prospects, it still faces some difficulties. For example, the research and development of products, many companies believe that the production of children's drugs is very simple, only need to slightly change the amount of adult drugs, in fact, this is not the case, children's drugs must be distinguished from adult drugs for research and development, and this is for some companies Short board. On the other hand, there is no unified spectrum of childhood diseases in China, but research and development around some existing diseases of children. The research and development of such drugs is relatively low in gold.
It is understood that on March 7, the State Food and Drug Administration issued the "Guidelines for Clinical Trial of Clinical Trial of Pediatrics", from ethical considerations, data and safety monitoring, age stratification of subjects, and pediatric dosage form selection. Detailed instructions. Among them, in the formulation selection of dosage forms, it is specifically mentioned that the acceptance of the dosage form by the pediatric population will be affected by the taste, smell and texture of the drug itself, and attention should be paid to the "pill size and shape".
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