The National Health Commission recently issued the "Notice on Printing and Distributing the Third Batch of List of Children's Drugs Encouraging Research and Development", and 34 varieties of clopidogrel, tacrolimus, and voriconazole are encouraged to be developed.
The notice shows that in order to further implement the requirements of the original National Health and Family Planning Commission and other six departments "Several Opinions on Protecting Children’s Drugs" (Guowei Yaozhengfa [2014] No. 29), promote the development, creation and application of suitable varieties, dosage forms and specifications for children After reviewing and meeting the needs of pediatric clinical medications, the National Health Commission, the Ministry of Industry and Information Technology, and the State Food and Drug Administration continued to closely focus on the spectrum of children’s diseases in my country and the R&D and production capabilities of relevant companies to formulate the Third Batch of List of Encouraging R&D and Application for Children’s Drugs.
From the list of the third batch of encouraged drugs for children, it can be found that among these 34 varieties, there are many large varieties with sales exceeding 1 billion in the domestic hospital market, such as clopidogrel, tacrolimus, voriconazole, etc.
In recent years, the safety of children's medication has attracted much attention from the society. Because children's medication is relatively special, compared with adult medication, the rate of research and development and use are relatively low, and there are fewer companies that can invest in research and development. In order to encourage more pharmaceutical companies to develop children's medicines, my country has adopted a series of measures to provide support in many aspects.
For example, in terms of encouraging R&D application, on June 1, 2016, the "List of the First Batch of Children's Drugs to Encourage R&D Application" was released. The list lists 32 varieties including diphenhexyl, and manufacturers are encouraged to apply for R&D; May 31, 2017 On July 1, the "Second Batch of Recommendations for Encouraging Research and Development and Declaration of Children's Drugs" was released. A total of 40 clinically urgently needed children's drugs were included in the recommended list to further solve the shortage of children's drugs in my country.
Now the third batch of children's medicines list for encouraging research and development is released. It can be seen that almost a batch is released every year. As more companies invest in the research and development of children's medicines, the shortage of children's medicines will be further improved, which is also conducive to better Of children’s medication needs.
In fact, entering 2019, encouragement and support policies related to children's medication have also been continuously introduced. Among them, the "2019 National Medical Insurance Drug List Adjustment Work Plan" clearly stated: "Priority will be given to the national essential drugs, cancer and rare diseases and other major disease treatment drugs, chronic disease drugs, children's drugs, emergency rescue drugs, etc." In addition, August In the newly announced list of medical insurance drug catalogue adjustments, there are also children's drugs among the newly added varieties.
Recently, the newly revised Drug Administration Law was voted through. Among them, with regard to children's medicines, the state specifically stipulates that the state should take effective measures to encourage the development and innovation of children's medicines, support the development of new varieties, dosage forms and specifications of children's medicines that meet the physiological characteristics of children, and give priority to children's medicines for review and approval.
It is reported that the next step in the implementation of the Drug Administration Law, the drug regulatory authorities will study specific related supporting regulations and policies, and issue corresponding technical guidelines to encourage and promote the development and innovation of children's drugs.
It can be seen that with the release of these favorable policies, the lack of dosage forms and specifications for children's special drugs in my country will be gradually improved, and the demand for pediatric clinical drugs will be better met.
The industry believes that the current market for children's medicines only accounts for 5% of the pharmaceutical industry, while children account for about 16.6% of the country's population. Driven by the second-child policy, the demand for medicines for children will continue to expand, and the market for medicines for children is expected to grow in the future, exceeding 100 billion yuan. For pharmaceutical manufacturers listed on the encouraged list, good development opportunities will be obtained, and future market competition will become more intense.
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