Following the issuance of "Document No. 9," national policies have further released a clear signal supporting "genuine innovation."

 

Late on May 9, the National Healthcare Security Administration (NHSA) released the "Work Plan for the Adjustment of the 2026 National Reimbursement Drug List (NRDL) for Basic Medical Insurance, Maternity Insurance, and Work-Related Injury Insurance (Draft for Comments)." The document systematically establishes the working principles for the new round of NRDL adjustments, covering application guidelines, renewal rules, bidding rules, and linkage with commercial health insurance.

 

This marks the official commencement of the annual NRDL adjustment process. Compared to previous years, the overall timeline for the 2026 NRDL adjustment has been advanced by approximately one month. The adjustment plan also demonstrates greater inclusiveness and systemic flexibility toward innovative drugs across multiple dimensions.

 

For the first time this year, a "pre-application" mechanism has been introduced, allowing certain innovative drugs that have not yet received formal approval but have completed technical review to participate in early application. Additionally, the linkage mechanism between the commercial health insurance innovative drug list and the basic NRDL has been further strengthened. The construction of a multi-tiered payment system is now being integrated more deeply into the NRDL negotiation framework.

 

Overall, through an advanced timeline, the flexibility of pre-application, the linkage with the commercial insurance list, and refined adjustments to renewal and price control rules, the 2026 NRDL adjustment is building a more predictable, more flexible, and more supportive access environment for genuine innovation at a systemic level. For local innovative drug companies in a critical commercialization phase, this is not only an optimization of rules but also a profound reshaping of industry expectations and value assessment systems.

 

TONACEA 01: Pre-Application Mechanism Solves the Time Lag Problem

 

From the draft document, one of the most closely watched changes this year is the structural adjustment to application rules and access timelines.

 

The introduction of the "pre-application" mechanism is regarded as one of the most landmark systemic changes in this round of NRDL negotiations.

 

According to the draft document, the cutoff date for drug applications has been changed to drugs that have received approval or completed technical review by the date the plan is formally issued. This means that some innovative drugs that have not yet received formal approval but have completed technical review can participate in the list application process, provided they submit formal drug registration approvals by a specified deadline.

 

In previous years, the application deadline was fixed at June 30. Companies needed to obtain formal NMPA registration approval before this date to qualify for that year's NRDL negotiations. However, the NMPA's review and approval process has its own timeline, leading to many innovative drugs being approved just after June 30. The consequence was that companies would miss that year's negotiation and have to wait an entire year.

 

For a marketed innovative drug, this one-year delay could mean postponed commercial returns, increased cash flow pressure, lost competitive advantage, disrupted biotech financing schedules, and unnecessarily extended waiting times for patients.

 

The essence of the pre-application mechanism is the national-level recognition of, and attempt to solve, the time lag between NMPA review/approval and NRDL access. It helps compress the timeline between a drug's approval, NRDL negotiation, and hospital entry, allowing companies to secure a more critical market window.

 

TONACEA 02: Conditionally Approved Drugs Gain a "5+3" Window

 

If the pre-application mechanism addresses the timing of "when to apply," the rule optimization for conditionally approved drugs responds to the practical challenge of "what to do when evidence is insufficient." This year's plan further reflects the NRDL evaluation system's respect for the natural timeline of clinical evidence accumulation.

 

According to the draft document, drugs that received conditional approval after 2020 and later converted to regular approval will be given an extended application window. In addition to being eligible within 5 years of conditional approval, if they convert to regular approval at any point within those 5 years, they will be eligible for an additional 3 years following regular approval. This means these drugs could potentially receive a "5+3 years" total application window.

 

The NHSA explained that considering that conditionally approved drugs require time for confirmatory study completion and regular approval conversion, granting a wider application window will help better confirm the drug's clinical value.

 

In the past, in areas such as oncology and rare diseases, although some innovative drugs received early conditional approval, in some annual reviews, certain new drugs failed expert evaluation due to "insufficiently validated efficacy" or "lack of long-term safety data" before launch.

 

With the implementation of the "5+3" mechanism, relevant companies will have more ample time to complete confirmatory studies and accumulate real-world evidence. This not only better aligns with review and approval policies but also fully demonstrates the NHSA's support for innovation and respect for evidence.

 

TONACEA 03: Paving the Way for Commercial Insurance and NRDL Synergy

 

More crucially, the gradual establishment of a systemic linkage between the commercial health insurance innovative drug list and the basic NRDL is seen by the industry as an essential step toward a multi-tiered payment system.

 

Previously, the guiding principle for NRDL access had always been "basic protection" – clinical necessity, safety and efficacy, and reasonable pricing. This means that CAR-T therapies, some high-value rare disease drugs, and new drugs lacking sufficient real-world evidence after launch would struggle to enter the basic NRDL in the short term.

 

In January 2026, the first commercial health insurance innovative drug list, first released by the NHSA in 2025, was officially implemented, covering 19 innovative drugs from 18 manufacturers, spanning areas such as oncology, rare diseases, and chronic conditions.

 

Following the first version of the list, a second version is coming. According to the draft document, exclusive drugs meeting certain criteria can apply solely for the commercial insurance list or for both the commercial insurance list and the basic NRDL.

 

More crucially, the draft document explicitly adds "inclusion in the 2025 Commercial Health Insurance Innovative Drug List" as a condition for applications of drugs not currently in the NRDL. This adjustment appropriately expands the scope of eligible drugs and reflects the linkage between the two lists, stabilizing companies' interest in the commercial insurance list. It also allows drugs already on the commercial insurance list to apply based on new indications.

 

Overall, this reveals a "tiered access" pathway designed at the national level:

 

• Tier 1: Commercial insurance coverage first. High-value innovative drugs, rare disease drugs, and others unlikely to enter the basic NRDL in the short term will be prioritized for inclusion in the commercial insurance list, receiving payment support through private insurance.

• Tier 2: Accumulate real-world evidence. Through commercial insurance coverage, drugs accumulate real-world evidence, gradually validating their clinical and economic value.

• Tier 3: Transition to NRDL. With solid data, drugs can meet NRDL access requirements, eventually achieving the tiered payment path of "commercial insurance first, NRDL follow-up."

 

This is the underlying logic of the multi-tiered payment system – basic insurance for essential protection, commercial insurance for supplementary coverage. The two lists must work in concert to truly cover the payment gap for innovative drugs.

 

TONACEA 04: Price Governance and Renewal Rules Improve in Parallel

 

Beyond changes to access rules and payment pathways, the refinement of the price governance system in this year's negotiation is equally noteworthy.

 

According to the draft document, a coordinated mechanism between the NRDL payment standard for bid-winning drugs and the online hospital procurement price will be established this year. If the procurement price exceeds the negotiated payment standard by 1.8 times, a yellow light warning will be issued; if it exceeds by 3 times, a red light warning will be issued.

 

Previously, although some bid-winning drugs entered the NRDL with a low payment standard, a significant gap remained between their actual procurement price and the standard. As the red/yellow light warning mechanism is introduced, the binding constraint of NRDL payment rules on the final pricing system will be further strengthened.

 

At the same time, the further clarification of renewal rules sends a signal of long-term stability for innovative drugs.

 

According to the draft document, for exclusive drugs that have completed an 8-year agreement period, the price adjustment will be calculated based on two methods: the "price reduction rate calculated by the simple renewal rules" and the "additional price reduction linked to average annual imputed fund expenditures exceeding RMB 300 million." The higher reduction rate will be used as the basis for adjusting the payment standard.

 

This means that the NHSA is gradually establishing a more long-term, predictable pricing governance system for innovative drugs. Past market concerns about "how to renew after 8 years" or "how prices will be adjusted after transitioning to the regular list" will gradually dissipate as rules are clarified.

 

Furthermore, the draft document also adjusts the parameters for drug expenditure calculation. For drugs whose dosing is based on body weight, the standard adult weight has been adjusted from the previous 60 kg to 65 kg, and body surface area parameters have been adjusted accordingly (to 1.68 square meters). For some oncology drugs and biologics dosed by weight, these parameter changes may also impact subsequent fund expenditure calculations and negotiation price floors.

 

Conclusion

The 2026 NRDL adjustment is no mere technical adjustment of timelines or application rules. From the pre-application mechanism to price warnings and refined renewal rules, each change is reshaping the value realization pathway for Chinese innovative drugs.

 

For local innovative drug companies, the anxiety of "rushing to file before the deadline" is being replaced by a more predictable institutional environment. The tiered access path of "commercial insurance first, NRDL follow-up" means that life-saving therapies no longer have to bet everything on securing a spot in the basic NRDL. The increased transparency of price governance and renewal rules is providing a stronger institutional foundation for the commercial model of an entire drug lifecycle.

 

Of course, the dividends of these rules will only flow to "genuine innovation" – and the foundation of genuine innovation will always be robust clinical evidence.

 

References:

1. NHSA, Interpretation of the "Work Plan for the Adjustment of the 2026 National Reimbursement Drug List (NRDL) for Basic Medical Insurance, Maternity Insurance, and Work-Related Injury Insurance (Draft for Comments)" and related documents

2. Cailianshe, 2026 NRDL Negotiation Introduces Pre-Application for the First Time: Alleviates Companies' "Last-Minute Filing" Anxiety, Strengthens NRDL-Commercial Insurance Linkage

3. ZBao Tony, Innovative Drugs Entering NRDL: No More "Last-Minute Approvals" – Is Spring Coming for Commercial Insurance?