The National Health Commission (NHC), National Healthcare Security Administration, National Medical Products Administration (NMPA), and two additional ministries have released a third list of pediatric drugs aimed at encouraging and guiding drug developers in product development and filings. The list includes a total of 24 varieties, involving 30 specifications and 9 dosage forms, covering areas such as the neurological system, digestive tract and metabolism, and anti-tumor and immune modulators.
Features of the New List
The list is characterized by several key features:
- It emphasizes clinical medication needs, with the majority of the drugs not yet available on the Chinese market.
- The majority of the drugs are in forms that are easy for children to use, such as oral solutions and nasal powders.
- The list includes some drugs for rare diseases.
- It encourages manufacturers with potential clinical application and market space, as assessed by data analysis and expert argumentation.
Previous Lists and Their Impact
Previously, three such lists have been released since 2016, including a total of 105 drugs. Among these, 23 drugs have been approved for marketing, covering antitumor drugs and immune modulators, nervous system drugs, and medication for mental disorders across 8 treatment areas, with 6 therapies for rare diseases. The release of these lists has been instrumental in driving the development and availability of pediatric medications in China.-Fineline Info & Tech
