By Fineline Cube China’s National Healthcare Security Administration (NHSA) released preliminary formal review results for the 2026 National Drug Catalog adjustment, advancing a record 674 generic drug names from 818 submission packages received between June 1–10, 2026. The process covers both the National Catalog of Drugs for Basic Medical Insurance, Maternity Insurance, and Work-Related Injury Insurance and the Commercial Insurance Innovative Drug Catalog.
Submission & Review Statistics
| Category | Submitted | Passed | Pass Rate |
|---|---|---|---|
| Out-of-list applications | 375 | 334 | 89% |
| Within-catalog applications | 229 | 223 | 97% |
| Commercial insurance catalog (external) | 57 | 53 | 93% |
| Commercial insurance catalog (internal) | 1 | 1 | 100% |
| Overall (excluding pre-submitted) | 662 | 611 | 92% |
Key Metrics & Year-over-Year Comparison
| Metric | 2026 | 2025 | Change |
|---|---|---|---|
| Total submission packages | 818 | 718 | +100 |
| Generic drug names | 674 | 633 | +41 |
| Preliminary pass rate | 92% | 84% | +8 ppt |
| New drugs (past 5 years) | 343 | N/A | New tracking |
Pre-Submission Activity Summary
- 49 generic names pre-submitted for out-of-list inclusion (including 2 with simultaneous new indication applications)
- 11 generic names within basic catalog pre-submitted for new indications
- 4 generic names pre-submitted for inclusion outside commercial insurance innovative drug catalog
Strategic Implications
- Market Access Acceleration: The 92% preliminary pass rate—up 8 percentage points from 2025—indicates NHSA’s streamlined evaluation process while maintaining quality standards
- Innovation Focus: Majority of submissions represent new drugs, with 343 newly approved generic drugs from the past five years submitted under Criterion 1 (outside catalog)
- Industry Confidence: Record submission volume reflects growing pharmaceutical industry confidence in China’s national insurance reimbursement framework
- Patient Impact: Successful catalog inclusion will expand patient access to innovative therapies across basic medical, maternity, and work-related injury insurance coverage
The preliminary clearance sets the stage for the next phase of price negotiations and final inclusion decisions, positioning manufacturers for competitive advantage in China’s healthcare market.
Forward-Looking Statements
This brief contains forward-looking information regarding regulatory processes and market expectations. Actual outcomes may vary based on final NHSA decisions, pricing negotiations, and market dynamics.-Fineline Info & Tech