China OKs 601 Drugs for 2026 Medical Insurance Review

China’s National Healthcare Security Administration (NHSA) announced on July 14 that 601 drugs have passed the formal review stage for inclusion in the 2026 National Medical Insurance Drug Catalog, marking a significant step in expanding access to essential medications for the country’s 1.3 billion insured residents. The announcement, reported by CCTV News, represents the initial screening phase of the annual catalog adjustment process.

Review Results and Pass Rates

The NHSA received 800 applications covering 664 generic drug names for the basic medical insurance catalog during the submission period from June 1 to June 10. Of these, 601 drugs successfully passed formal review, yielding an overall pass rate of 91 percent. Among the approved drugs, 368 are currently outside the catalog while 233 are already listed and seeking adjustments.

In a parallel track, the Commercial Health Insurance Innovative Drug Catalog received 62 applications covering 62 generic drug names, with 58 passing formal review at a 94 percent pass rate. Of these, 57 are new additions outside the current catalog and one is already listed.

According to the NHSA’s official announcement, the formal review is the initial step in the catalog adjustment process. Passing this stage only qualifies drugs for expert evaluation — it does not guarantee inclusion in the final catalog.

Year-over-Year Growth

Compared to 2025, this year’s application volume increased by 100 submissions (from 718 to 818) and 41 generic drug names (from 633 to 674). The preliminary formal review pass rate reached 92 percent (excluding pre-submitted varieties), up 8 percentage points from the previous year, indicating growing pharmaceutical industry engagement and better understanding of application procedures.

Key Policy Innovations in 2026

This year’s catalog adjustment introduces several notable changes. For the first time, a pre-submission mechanism allows drugs that completed technical review but had not received formal approval by the application deadline to pre-submit their applications.

As Xinhua News Agency reported, the 2026 adjustment simultaneously handles both the basic medical insurance catalog and the commercial health insurance innovative drug catalog, creating a linkage mechanism between the two systems. NHSA Director Huang Xinyu explained that the agency encourages high-value innovative drugs to apply for the commercial insurance catalog early in their market launch, reserving space for subsequent applications to enter the medical insurance catalog.

Three new application conditions have been added for drugs outside the catalog: drugs included in the 2025 Commercial Health Insurance Innovative Drug Catalog; drugs that transitioned from conditional to regular approval (with up to 3 additional years of eligibility); and same generic-name drugs of previously negotiated but de-listed products.

What Formal Review Means

The NHSA emphasized in its announcement that formal review is strictly an administrative screening step. “Passing formal review only means the drug meets the application requirements and qualifies for expert evaluation — it does not mean the drug has been included in the catalog,” the agency stated.

The initial public notification of preliminary review results occurred from June 29 to July 5, during which the NHSA received 103 feedback comments. Based on this feedback, the agency conducted a review and made corrections to 15 drug entries before publishing the final results.

Next Steps and Timeline

The 601 drugs that passed formal review will now proceed to expert evaluation, followed by negotiations for exclusive drugs and bidding processes for non-exclusive drugs. The final 2026 catalog is expected to be published in November 2026.

The NHSA has maintained a policy of annual dynamic adjustments to the drug catalog since 2018, replacing the previous irregular update schedule. This year’s adjustment continues the agency’s stated principle of “basic medical insurance ensures basic needs,” balancing coverage expansion with fund sustainability.

Broader Implications

The 91 percent pass rate and increased application volume signal a maturing pharmaceutical sector that is increasingly aligning with regulatory expectations. The dual-catalog system creates a tiered pathway for innovative drugs, potentially accelerating market access for high-value treatments while maintaining cost control.

For China’s patients, continued catalog expansion improves affordability of both Western and traditional Chinese medicines. The final catalog, expected in November, will determine which of the 601 drugs ultimately gain coverage under the national scheme, affecting millions of patients across the country.