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E-mail China.org.cn, October 16, 2024
Xing Huina:
One last question, please.
China Daily:
The issue of pediatric medication has received wide attention and has also been one of the NMPA's priorities in recent years. What progress has been made? What follow-up work will be done by the NMPA? Thank you.
Li Li:
Children are the future of our country and represent our greatest hope. Thanks to the reporter for your interest in pediatric medication. I'll now turn to Mr. Huang to answer this question.
Huang Guo:
Pediatric medication is a common global challenge and a complex issue. Due to the difficulties in research and development, some diseases still lack appropriate treatments. For other conditions, medications exist, but questions remain about their use in children: whether they can be used, how they should be used, and unclear labeling information. In response to these issues, the NMPA has implemented multiple measures to encourage R&D and innovation in pediatric medications, standardize information on pediatric use in drug labels, and meet the clinical needs of young patients.
First, we have implemented a priority review and approval policy to accelerate the marketing of pediatric medications. We have worked with relevant departments to formulate a list of pediatric medications to encourage R&D and applications, achieving good results over the past three years. In 2021, 47 pediatric medications were approved, increasing to 66 in 2022 and 92 in 2023. From January to August this year, we have already approved 49 medications. These figures show a strong momentum of rapid growth in pediatric drug development. For example, we recently expedited the approval of Selumetinib Hydrogen Sulfate Capsules, currently the world's only specialized medication for treating neurofibroma in children. This medication was developed using a global synchronous R&D strategy. Based on international multicenter clinical trial evidence, it received simultaneous global marketing approval through our priority assessment and approval procedure, which will benefit many children.
Second, we have improved medication package inserts and added information on pediatric use. The NMPA has issued the Work Procedures for Adding Pediatric Medication Information to the Package Inserts of Marketed Drugs (for Trial Implementation). This initiative focuses on urgently needed pediatric clinical drugs, encouraging companies to strengthen scientific research while regulatory authorities conduct rigorous evaluations. As a result, information on pediatric use is being added to drug labels, enhancing the safety and efficacy of medications in pediatric clinical practice.
To date, we have issued revision announcements for 49 product specifications across 15 drug varieties in three batches. The newly added pediatric use information covers antineoplastic drugs, such as those for childhood leukemia, which is of particular concern, as well as medications for severe mental disorders in children, including autism, depression, schizophrenia and other serious conditions.
Additionally, we have accelerated improvements to R&D technical requirements, aligning them with international standards. We've issued 21 standards and guidelines for pediatric drug development, comparable to those of regulatory agencies in developed countries. Among these, the Guidance on Real-World Studies to Support Pediatric Drug Development and Regulatory Evaluation of and the Guidance for the Design and Evaluation of Pediatric Drug Palatability are world firsts, placing us at the forefront of global regulatory practices in this field.
Moving forward, the NMPA will continue to prioritize the safety and accessibility of pediatric medications. With the attention and support of society at large, we will further strengthen our support for the R&D and production of pediatric drugs, enhance the supply of medications for children, and provide greater reassurance to parents. Thank you.
Xing Huina:
This concludes today's press conference. Thank you to our speakers and to all members of the media for attending. Goodbye.
Translated and edited by Wang Yiming, Wang Wei, Zhu Bochen, Wang Qian, Wang Ziteng, Huang Shan, Zhang Jiaqi, Zhou Jing, Xiang Bin, Yuan Fang, Yang Chuanli, Li Huiru, Liu Caiyi, Liu Qiang, Xu Kailin, Wang Yanfang, David Ball, Jay Birbeck, and Rochelle Beiersdorfer. In case of any discrepancy between the English and Chinese texts, the Chinese version is deemed to prevail.
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