On September 13, the State Council Information Office hosted a press conference as part of its “Promoting High-Quality Development” series. During the event, Huang Guo, Deputy Director of the National Medical Products Administration (NMPA), highlighted the challenges surrounding pediatric medicines, which he described as a significant global issue in medical advancement. He pointed out that the complexity of developing medications for children leads to two pressing concerns: some diseases are experiencing a “wait for medicine” dilemma, while others have existing treatments, but their usage guidelines are unclear.

To tackle these challenges, the NMPA is implementing a variety of measures aimed at fostering innovation in pediatric drug development. One key initiative involves standardizing the information provided in drug labeling regarding pediatric applications, with the intention of better addressing the clinical medication needs of children.

Huang emphasized that the NMPA has introduced priority review and approval policies to speed up the market introduction of pediatric medications. The agency has partnered with relevant departments to compile a list designed to promote research and application for pediatric drugs, and the results over the past three years have been noteworthy. In 2021, 47 pediatric drugs were approved, increasing to 66 in 2022, and reaching 92 in 2023. Remarkably, in the first eight months of this year alone, 49 approvals have already been completed, showcasing a robust growth trend in the development of new pediatric medications.

Furthermore, the NMPA is enhancing drug labeling to include more comprehensive information regarding pediatric usage. They have released the “Procedure for Adding Pediatric Medication Information to Approved Drug Labels (Trial),” prioritizing urgently needed clinical medicines for children. This initiative requires pharmaceutical companies to bolster scientific research while regulatory bodies conduct thorough evaluations to integrate pediatric application information into drug labeling, ensuring the safety and efficacy of clinical medications for young patients.

To date, the NMPA has issued three batches of announcements revising 49 specifications across 15 drug categories to include pediatric information. These updates cover new data on pediatric oncology drugs, addressing critical issues such as childhood leukemia, as well as treatments for severe mental health disorders affecting children, including autism, depression, and schizophrenia.

Additionally, the NMPA is refining research and development technical requirements to align with international standards. They have rolled out 21 standards and guidelines for pediatric drug development that are in step with those of developed countries. Among these, the “Technical Guidelines for Real-World Studies Supporting Pediatric Drug Development and Review” and the “Technical Guidelines for Flavor Design and Evaluation in Pediatric Medications” are pioneering contributions within the regulatory framework.

Looking to the future, Huang Guo asserted that the NMPA will maintain a strong focus on the safety and accessibility of pediatric medications. With the backing and awareness of society, the agency intends to further strengthen support for research, development, and production of pediatric drugs, ultimately providing parents with peace of mind regarding the availability of safe medications for their children.