Real-world research will support research and development of children's medicines, and the industry is taking a new step forward.

Taking into account the actual needs of china's children's drug research and development and drug registration, to help enterprises better understand the "real-world evidence-backed drug research and development and review guidelines (trial)" in children's drug research and development applications, recently, under the deployment of the State Drug Administration, the Drug Review Center organized the development of "real-world research to support children's drug research and development and review of the technical guidelines (trial)."
guiding principles point out that real-world research, as one of the new research methods, has been gradually used to support the development and review of children's medicines, to support the registration of new drugs, the expansion of childhood adaptations, and the improvement of dose programmes for children.
At the same time, the guiding principles clarify the difference between real-world research and traditional randomized controlled clinical trials and reasonable integration, point out the common situation of real-world research for children's drug research and development in China, and list two real-world studies for children's drug research and development in China, which will have important reference value and guiding significance for the industry.
In China, children's drug use refers to special drugs used by minors under 14 years of age, according to the National Bureau of Statistics data, the number of children in China has been on the rise for a long time, at the end of 2019, the national population aged 0-15 years old was 249.77 million people, accounting for 17.8% of the total population, the population base is huge.
and China's children's drug market is still very immature, especially children's drug varieties, vague dosages, lack of specifications is more prominent.
statistics show that china's drug registration approval, the proportion of children-specific drugs less than 2%, high-quality children's pharmaceutical products market growth space is huge.
industry insiders pointed out that the guidelines issued this time in response to industry concerns - introduced the current real-world research to support China's children's drug research and development of common situations and concerns, and gave cases and explanations, I believe that this industry will have a very important reference value and guiding significance.
also seen regulators take another solid and important step in the study of drug authenticity.
With the implementation of the "Healthy China" strategy, the continuous improvement of health and health science and technology innovation capabilities, the continuous improvement of laws and regulations to protect and encourage children's drug use, the continuous emergence of research and development of children's drug professionals, China's innovative development of children's drug use will usher in a new opportunity to meet the diverse medical and health needs of children.
It is understood that in recent years, the field of children's medicine has been a number of good policies, such as the state issued "on ensuring the use of children's medicine", "on strengthening the reform and development of children's health services" and other relevant documents, began to further reform the field of children's health services, strengthen the quality of children's drug supervision.
with the strengthening of national policy support for the development of children's medicine, China's children's drug market may be vigorously developed in the future.
Research predicts that the size of China's children's drug market is expected to maintain double-digit compound growth in the future, while the state's concern for children's growth and social and family awareness of drug use will gradually increase the size of the children's drug market.
expected that by 2020, China's children's drug-specific scale will reach 107.9 billion yuan, the total scale of children's drug demand will reach 300 billion yuan.
with the release of all kinds of good news, the development prospects of the industry is becoming more and more clear, in recent years, some enterprises in the development of children's medicine has also begun to lay out in depth.
Such as an enterprise said that the company produces children's medicine products rich structure, complete product echelons, a wide range of therapeutic fields, it has 7 children-specific varieties of products covering more than 70% of children's common diseases, involving a number of disease areas.
At the same time, the company has a number of products were rated as high-tech products, according to china's pharmaceutical industry information in the new data show that the company's production of children's drug Klinmycin palmate dispersion tablets in the lincoamide products for three consecutive years in the market share of the forefront.
, with the introduction of a number of policies, children's drug research and development innovation has been encouraged, children's drug registration application approval cycle will be gradually shortened, children's drug market will be better developed.
And the release of this guiding principle, but also pointed out that real-world research as a new research method, has been gradually used to support the development and review of children's drugs, for the registration of new drugs, expand children's adaptation, improve children's dosage programs, etc. , which may further promote the development of China's children's drug industry.
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