In the first eight months, China approved 49 children's drugs for market launch

2024-10-10

Huang Guo, Deputy Director of the National Medical Products Administration, stated that from January to August this year, a total of 49 children's drugs were approved for market in China, accelerating the speed of children's drug market launch. This was introduced by Huang Guo at the "Promoting High Quality Development" series of themed press conferences organized by the State Council Information Office. He said that the development of drugs for children is a global challenge. Due to the difficulty of research and development, some diseases have the problem of "waiting for drugs", while others have drugs but there are problems of "whether they can be used, how to use them, and unclear". In response to these issues, the National Medical Products Administration has taken multiple measures to encourage innovation in the research and development of pediatric drugs, standardize the information on pediatric use in drug instructions, and strive to meet the clinical needs of pediatric patients. In recent years, the research and development of new drugs for children in China has shown a rapid growth trend. Huang Guo said that looking back at the past three years, the number of approved pediatric drugs was 47 in 2021, 66 in 2022, and 92 in 2023. The National Medical Products Administration has also urged drug manufacturers to improve drug instructions and increase information on pediatric medication. It has issued the "Work Procedure for Adding Pediatric Medication Information to Listed Drug Instructions (Trial)", which aims to standardize and supplement the pediatric application information in the instructions through scientific evaluation methods for urgently needed pediatric clinical drugs. As of now, three batches of 15 varieties and 49 product specification revision suggestions have been announced, involving autism, depression, schizophrenia, malignant tumors and other diseases in children. In addition, the National Medical Products Administration has strengthened the construction of a scientific supervision system for children's medication, and has issued 21 standards and guiding principles for the research and development of children's medication, which is comparable to the regulatory level of developed countries. Huang Guo said that the National Medical Products Administration will continue to prioritize ensuring the safety and accessibility of medication for children, further increase support for the research and development of medication for children, and strengthen medication protection for children. (New Society)

Edit:Chen Jie    Responsible editor:Li Ling

Source:Xinhuanet

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