By Fineline Cube The National Healthcare Security Administration (NHSA) has released its draft 2026 Work Plan for Adjusting the National Basic Medical Insurance, Maternity Insurance, and Work-Related Injury Insurance Drug List alongside the Commercial Health Insurance Innovative Drug List (CHIDL), officially commencing the annual National Reimbursement Drug List (NRDL) adjustment process.
Key Regulatory Changes
| Change Area | Previous Standard | 2026 Adjustment |
|---|---|---|
| Eligibility Cut-off Date | June 30 | Official issuance date of final work plan |
| Application Timeline | Standard schedule | Advanced by approximately one month |
| Adult Weight Standard | 60 kg | 65 kg |
| Body Surface Area | Previous standard | 1.68 m² |
Major Policy Innovations
1. Flexible Drug Eligibility Window
The NHSA proposes shifting the exclusive drug eligibility deadline from the traditional June 30 cutoff to the official issuance date of the final adjustment work plan, providing greater flexibility for pharmaceutical manufacturers.
2. Introduction of Pre-Application Mechanism
For the first time, drugs that have not yet received formal marketing approval but have completed technical review by application opening are permitted to pre-apply. This expands the submission window to include “drugs that have received marketing approval or completed technical review on or before the official issuance date of the work plan.”
3. Expanded Off-List Drug Criteria
Three new pathways now qualify previously excluded drugs:
- Drugs included in the 2025 Commercial Health Insurance Innovative Drug List (CHIDL)
- New generic drugs granted conditional NMPA approval after January 1, 2020, subsequently converted to regular approval between January 1, 2023, and the work plan issuance date
- Previously negotiated drugs removed due to unsuccessful renewal, where the first generic version was approved between January 1, 2021, and the document issuance date
4. Enhanced Removal Criteria
Greater emphasis will be placed on removing Chinese patent medicines with incomplete safety information, specifically those maintaining “unknown” designations for contraindications, adverse reactions, and precautions without providing required data within mandated timeframes.
5. Updated Dosage Calculation Standards
Reflecting demographic changes documented in the National Physique Monitoring Bulletin, weight-based drug cost calculations now use 65 kg for adults (previously 60 kg) and 1.68 m² for body surface area, aligning with regional drug listing calculation rules.
Implementation Timeline & Market Impact
- Work Plan Finalization: Expected by end of May 2026
- Updated NRDL & CHIDL Publication: Scheduled for end of November 2026
- Industry Impact: The linkage between NRDL and CHIDL strengthens commercial insurance integration while maintaining manufacturer incentives for innovative drug development
The advanced application timeline provides pharmaceutical companies additional preparation time for post-listing implementation and commercial insurance coordination, potentially accelerating market access for newly reimbursed products.
Forward-Looking Statements
This brief contains forward-looking statements regarding regulatory timelines and policy implementation. Actual results may differ due to administrative processes, stakeholder feedback, and final regulatory decisions.-Fineline Info & Tech