According to information released by the National Medical Products Administration on the 1st, since 2024, 21 children's drugs in China have been approved for marketing, and one-third of them have been accelerated through priority review and approval procedures. In recent years, the National Medical Products Administration has increased policy support for the research and development, evaluation, and production of pediatric drugs, resulting in a significant increase in the number of pediatric drugs on the market. Since 2019, the National Medical Products Administration has approved a total of 271 children's medicines. To address the urgent and difficult medication needs in pediatric clinical practice, the National Medical Products Administration has taken multiple measures to strengthen the guarantee of medication for children. In the process of children's drug research and development, in order to better serve enterprises, promote children's drug research and development, and improve the quality of application materials, the National Medical Products Administration closely communicates with research and development institutions to guide them to better and faster advance their research and development work. In the registration and application process, the National Medical Products Administration provides policy support such as priority evaluation and approval. Recently, the list of pediatric medications with priority review and approval has been launched on the website of the Drug Evaluation Center of the National Medical Products Administration. In the clinical use stage, in order to solve the problem of exceeding the instructions in pediatric clinical practice, the National Medical Products Administration issued the "Work Procedure for Adding Children's Medication Information to the Instructions of Marketed Drugs (Trial)" in May 2023, and the "Work Rules for Adding Children's Medication Information to the Instructions of Marketed Drugs (Trial)" by the Drug Review Center on April 18, 2024, further clarifying the scope of variety selection, the revision and review process of instructions, and the variety declaration process, to improve the level of clinical safe medication. The National Medical Products Administration stated that the next step will continue to increase policy tilt, promote priority evaluation and approval of children's medication, and increase intellectual property protection for children's medication; Develop technical guidance principles for the clinical needs of pediatric medication, fully consider special requirements such as safety and suitability of pediatric medication, improve enterprise research and development level, and accelerate research and development speed. (Lai Xin She)
Edit：GuoGuo Responsible editor：FangZhiYou
Source：gmw.cn
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