--- title: "China to Give Innovative Pediatric Drugmakers Market Exclusivity of Up to Two Years" type: "News" locale: "en" url: "https://longbridge.com/en/news/285675490.md" description: "China will grant up to two years of market exclusivity to manufacturers of eligible innovative pediatric drugs to boost R&D in pediatric medicines. The new policy, issued by the National Health Commission and other ministries, also introduces patent term compensations and aims to support the development of treatments for common childhood diseases and rare diseases. Regulators will assist in improving drug development efficiency and prioritize registration applications for innovative pediatric drugs. Additionally, the government will explore a national pediatric clinical trial network and support the development of commercial insurance products for children." datetime: "2026-05-08T06:45:47.000Z" locales: - [zh-CN](https://longbridge.com/zh-CN/news/285675490.md) - [en](https://longbridge.com/en/news/285675490.md) - [zh-HK](https://longbridge.com/zh-HK/news/285675490.md) --- # China to Give Innovative Pediatric Drugmakers Market Exclusivity of Up to Two Years (Yicai) May 8 -- China will grant manufacturers of eligible innovative pediatric drugs a market exclusivity period of up to two years to encourage the research and development of pediatric medicines and support innovation. In addition to market exclusivity, the new policy issued yesterday by the National Health Commission and seven other Chinese ministries also introduces patent term compensations for pediatric drugs that meet certain requirements. This policy, which is the first update to China’s first comprehensive policy document to ensure the availability of pediatric drugs released in 2014, will focus on supporting the R&D of innovative drugs for common childhood diseases, combination vaccines, suitable formulations for pediatric medications, and treatments for rare diseases in children. For designated innovative pediatric treatments, regulators will assist developers in continuously improving the efficiency of drug development through early intervention, coordinated review processes, and rolling submissions. The government will encourage the research of new tools, methods, and standards for pediatric drug regulation and explore the possibility of setting up a national pediatric clinical trial collaboration network and a cross-institutional ethical review mechanism to address challenges, such as low efficiency in pediatric drug development and recruiting participants. The regulators also pledged to support the enhancement of real-world evidence and prospective research design within a multi-center collaboration model, as well as the extrapolation of existing drug safety data from the adult to the pediatric population in China. Moreover, the regulators will give review and approval priority to the registration applications for drugs included in the list of encouraged innovative pediatric drugs and generic medicines, as well as accelerate their inclusion in the National Essential Medicines List. The NHC, together with the National Medical Products Administration, will develop a list of commonly used pediatric formulations by medical institutions for drugs that are clinically necessary but unavailable on the market or without pediatric-specific formulations and dosages. It will also take the lead in formulating clinical application guidelines for pediatric medications and exploring the development of a National Essential Medicines List for children. The regulators will support the development of commercial insurance products for children covering innovative drugs and medications for rare diseases. During the centralized procurement of drugs, incentive policies will be implemented to support the supply of formulations and specifications suitable for children. Editors: Tang Shihua, Futura Costaglione ### Related Stocks - [.HXC.US](https://longbridge.com/en/quote/.HXC.US.md) - [DRAG.US](https://longbridge.com/en/quote/DRAG.US.md) - [PGJ.US](https://longbridge.com/en/quote/PGJ.US.md) - [MCHI.US](https://longbridge.com/en/quote/MCHI.US.md) ## Related News & Research - [China April data misses badly, Iran war and weak demand weigh. Retail sales growth plunge.](https://longbridge.com/en/news/286703491.md) - [Economic and event calendar in Asia Monday, May 18, 2026 - Chinese April data](https://longbridge.com/en/news/286681923.md) - [Project helps turn around lives of special needs children and their parents](https://longbridge.com/en/news/286424988.md) - [BioMarin Provides Update on Phase 3 Trial for BMN 401 in Children Aged 1-12 With ENPP1 Deficiency | BMRN Stock News](https://longbridge.com/en/news/286776398.md) - [Kids digital safety concerns collide with prediction market debate](https://longbridge.com/en/news/286901836.md)