China Proposes New Drug Reimbursement Rules and Pediatric Medicine Reforms

China’s National Healthcare Security Administration (NHSA) has released the draft 2026 work plan for adjustments to the National Reimbursement Drug List (NRDL) and the Commercial Health Insurance Innovative Drug List (CHIDL), officially starting this year’s reimbursement review process. Several policy changes were included in the draft plan.  For example, previously, companies could only apply for NRDL consideration if their drug received approval by June 30 of that year. If approval came after that date, the company would generally need to wait until the following year’s NRDL cycle. Under the proposed rules, that cutoff would instead move to the date when the NHSA officially publishes its final work plan, which is expected later in the year. This change will give pharmaceutical companies more flexibility when preparing submissions. For the first time, drugs that have completed technical review but have not yet received formal marketing approval may pre-apply for NRDL consideration.

China’s National Health Commission (NHC) also recently announced a reform plan to improve the development, supply, and reimbursement of pediatric medicines in China. One of the key elements of the reform is to speed up the development and approval process for pediatric drugs. In particular, companies developing drugs on government-supported pediatric drug lists may be eligible for faster regulatory review and earlier inclusion in the national reimbursement and essential medicines lists. The policy also seeks to expand pediatric clinical trial infrastructure throughout China. Authorities plan to support specialized pediatric research wards and improve collaboration between hospitals conducting multi-center studies. At the same time, regulators are encouraging updates to pediatric labeling and treatment guidelines to help improve clinical use of these drugs.