The growth rate of paediatric drug use is amazing. This pharmaceutical company is approved with new drugs in the future

[pharmaceutical network market analysis] on December 27, Tianshi released a notice that paediatric new drug shaoma Zhijing granules (formerly known as Zhidong granules) received the approval document for drug registration issued by the State Food and drug administration According to some data, there are more than 360 million children in China, and the market scale of paediatric drugs has increased from 38.35 billion yuan in 2011 to 59.14 billion yuan in 2016, with an average compound growth rate of 9.05% In addition, in 2018, the market scale of paediatric drugs is close to 8 billion yuan, with an increase rate of 14.21%, which is far higher than the level line It can be predicted that children's medicine will be a very rapid growth and huge potential drug market in the future However, contrary to the potential drug market, the research and development of children's drugs has always been difficult because of the vulnerability of children's vital signs and the difficulty in tracking children's clinical reactions At present, among more than 3500 kinds of pharmaceutical preparations in China, only 1.7% are children's special dosage forms; among more than 4000 pharmaceutical enterprises in China, less than 5% are specialized in producing drugs for children, and the number of professional children's pharmaceutical brands is only one digit In addition, there are less than 600 special drugs for children whose generic names include the words "children" and "children", or whose functional indications or indications are described in the instructions, which are approved for marketing in China The number of approval documents for drugs involved accounts for about 3% of the total number of approval documents; The approved special drugs for children are mainly traditional Chinese medicine, and the indications are the same There are more granules in the dosage form, most of them are cold drugs In fact, there are also data showing that since 2010, only four new pediatric Chinese patent medicines have been approved for marketing in the past ten years, including Changma Xifeng tablet, Xiaoer Ganmaoning granule, Xiaoer Jianwei chewable tablet and shaoma Zhijing granule, among which Changma Xifeng tablet, Xiaoer Jianwei chewable tablet and shaoma Zhijing granule are single products Under the situation of children's drug safety, it is urgent to strengthen the research and development of children's drug innovation Therefore, in recent years, the state has begun to issue a number of policies to support the development of pediatric drug use: since 2013, China has accelerated the formulation of pediatric drug use specifications, and encouraged enterprises to produce pediatric specific dosage forms and specifications; the 2014 issue of several opinions on safeguarding children's drug use is China's first comprehensive guidance document on children's drug use in recent decades In 2016, the national drug regulatory department formulated and released the technical guidelines for extrapolation of adult drug use data to pediatric population to reduce unnecessary pediatric drug use research In 2019, the National Health Commission issued the list of the third batch of recommendations for encouraging the research and development of children's drugs, with a view to gradually improving the situation of the lack of specifications of special drugs for children in China and better meeting the clinical drug demand of Pediatrics The new version of drug administration law is the first time to promote the encouragement of children's drug use to a legal level, and will encourage children's drug development and innovation as a separate clause, which provides a legal basis for the next step to encourage the formulation and implementation of children's drug policy In fact, the guiding role of various policies has begun to show gradually According to the data from the national drug Audit Center, more than 30 listed drugs have entered the declaration stage From the overall situation, although the research and development of children's medicine is difficult, thanks to the policy support and rapid expansion of the market, it will continue to be favored by the industry in the next few years, or it will attract more pharmaceutical enterprises to increase the layout and investment.