Navigating China’s Pharmaceutical Market Access Landscape: Key Insights from the 2025 National Drug Catalog Adjustment

The recent release of the 2025 National Basic Medical Insurance, Maternity Insurance, and Work-related Injury Insurance Drug Catalog Adjustment Work Plan on July 10th, 2025, marks a pivotal moment for pharmaceutical companies operating in China. This comprehensive framework, accompanied by crucial supporting documents like application guidelines, renewal rules, and non-exclusive drug bidding rules, officially kicks off the 2025 National Reimbursement Drug List (NRDL) adjustment process. For market access specialists, this year’s adjustment is particularly significant, not only for its refined mechanisms for basic medical insurance but, crucially, for the inaugural establishment of a Commercial Health Insurance Innovative Drug Catalog. This dual-track approach signals a strategic shift towards a multi-tiered healthcare security system, demanding a sophisticated and adaptive market access strategy from industry players.

A Trajectory of Refinement: Evolution of China’s NRDL Adjustments

China’s NRDL adjustment mechanism has undergone a significant transformation since its inception in 2000, evolving through ten editions to its current sophisticated state. The establishment of the National Healthcare Security Administration (NHSA) in 2018 marked a turning point, ushering in a normalized adjustment process. Key milestones include:

• 2009: Integration with essential drug lists and the introduction of negotiation-based access rules.
• 2017: Further alignment with negotiated drugs, supporting Traditional Chinese Medicine (TCM) and innovative drugs.
• 2020: Implementation of enterprise self-
• 2021: Maturation and stabilization of adjustment rules, with increased emphasis on clinical comprehensive evaluation and pharmaco-economics.
• 2022: Introduction of non-exclusive drug bidding rules and removal of certain payment
• 2023-2024: Heightened support for innovative drugs and expansion of rare disease drug inclusion.

The negotiation and bidding process has similarly matured, with eight rounds of national negotiations completed since 2017, leading to substantial price reductions and increased access. For instance, the 2023 round saw 121 out of 143 drugs successfully negotiated or tendered, with an average price reduction of 61.7%. The 2024 round achieved an average price reduction of 63%.

2025 NRDL Adjustment: The Dual-Track Imperative

The 2025 adjustment largely mirrors the 2024 basic medical insurance adjustment scheme, upholding the principles of « filling gaps, optimizing structure, and encouraging innovation« . The process is structured into five distinct stages: preparation, declaration, expert review, negotiation, and results publication. The online application window is July 11th 9:00, to July 20th 17:00, 2025.

However, the most significant innovation this year is the introduction of the Commercial Health Insurance Innovative Drug Catalog. This new catalog aims to encompass innovative drugs that exceed the « basic » insurance scope but possess high innovation, significant clinical value, and substantial patient benefits. These drugs are recommended for reference by commercial health insurance, mutual aid, and other multi-tiered medical protection systems.

Eligibility for the Commercial Innovative Drug Catalog

 Drugs eligible for this new catalog are exclusive drugs that meet either of the following conditions:

• New Generic Name Drugs: Approved for marketing by the National Medical Products Administration (NMPA) between January 1, 2020, and June 30, 2025 (inclusive).
• Rare Disease Treatment Drugs: Approved for marketing by the NMPA by June 30,

Crucially, eligible drugs can either separately declare for the commercial innovative drug catalog or simultaneously declare for both the commercial innovative drug catalog and the basic medical insurance catalog. This « dual submission » pathway provides a strategic avenue for innovative drugs that might face challenges in immediate basic NRDL inclusion due to high cost or market impact but still offer significant clinical value. It also necessitates that companies submitting for the commercial catalog must provide information on their inclusion in inclusive commercial health insurance programs such as Huiminbao and other supplementary commercial health insurance plans.

Considerations for Pharma in China’s Evolving Reimbursement Landscape

The 2025 NRDL adjustment and the new commercial innovative drug catalog introduce several operational and strategic considerations for pharmaceutical companies.

Operational Efficiency: Streamlined Digital Process

 A key operational change for 2025 is the unified medical insurance information system module covering the entire NRDL adjustment process, from declaration to agreement signing. This system standardizes data submission and feedback, emphasizing the need for robust internal data management. Companies must ensure a single, consistent account is used throughout all stages.

Key Declaration Changes for Pharma

• Dual-Track Application: The explicit option to declare for both basic and commercial
• Detailed Adaptation Information: Enhanced requirements for multi-indication drugs, emphasizing comprehensive rather than selective reporting of new indications and approval times.
• Reference Drug Selection: Clarification that reference drugs should primarily be the most widely used in-catalog drugs within the same therapeutic area and mechanism of action.
• Fairness Information (New Requirement): For drugs applying to the commercial innovative drug catalog, companies must provide details on their inclusion in commercial health insurance products, including product descriptions, pricing/discount levels, and claims.
• Sales Data Focus:
  • Out-of-catalog drugs: Previously, 3 years of sales data; now, 1.5 years (full 2024 and Jan-June 2025) of sales data within the medical insurance payment scope, broken down by specification.
  • In-catalog drugs: Future sales projections shift from 3 years to 2 years for both current and new indications. This requires more precise short-term market

Negotiation Dynamics: Navigating Simplified Renewal and Re-negotiation

1.  Turn to Routine Management (Conventional Entry)

 The conditions for drugs to transition from negotiated status to routine catalog management have been tightened. Notably, the condition allowing exclusive drugs to become routine after two consecutive agreement periods without payment standard or scope adjustment has been removed. Now, only specific conditions apply:

• Government-priced narcotics;
• Drugs from national centralized procurement (VoBP);
• Non-exclusive drugs (based on generic drug prices);
• Exclusive drugs continuously in the « negotiated drugs » section for 8 years (as of Dec 31st of the adjustment year, applicable to drugs included in 2017).

2. Simplified Renewal: A Critical Focus on Payment Scope Expenses

 A significant change in simplified renewal is the shift from « fund expenditure » to « drug expenses within the scope of payment » (i.e., total drug expenses paid by both the fund and insured individuals) as the primary calculation metric. The thresholds for annual drug expenses have also been adjusted upwards (in green in both tables below), indicating a broader tolerance for volume growth before triggering price cuts.

Table 1: Simplified Renewal Price Adjustment (Ratio A) – Actual Sales vs. Forecast

Table 2: Simplified Renewal Price Adjustment (Ratio B) – Incremental Expenses due to Scope Adjustment

Strategic highlight: For Class 1 chemical drugs, Class 1 therapeutic biological products, and Class 1 TCM drugs, if Ratio A falls between 110% and 200%, companies can choose simplified renewal or apply for re-negotiation, where the price reduction may not necessarily be higher than that determined by simplified rules. Furthermore, a crucial rule states that if a drug has been continuously in the « negotiated drugs » section for 4 years or more (i.e., included before Jan 1, 2022), any triggered price reduction will be halved. This provides a degree of predictability and stability for long-standing innovative therapies.

3. Re-negotiation

 Exclusive drugs that do not meet the conditions for routine management or simplified renewal will be subject to re-negotiation. This pathway also explicitly allows Class 1 chemical drugs, Class 1 therapeutic biological products, and Class 1 TCM drugs to opt for re-negotiation even if they qualify for simplified renewal (110% < A ≤ 200%).

4. Non-exclusive Drug Bidding

 The rules for non-exclusive drug bidding remain consistent with the 2024 version. The lowest bid among competing enterprises sets the payment standard. A critical aspect is that if the lowest bid is less than 70% of the medical insurance payment willingness, 70% of the medical insurance payment willingness will be set as the payment standard.

Ensuring Market Access: Supply and Compliance

The new plan underscores the importance of supply assurance and data integrity. Companies must guarantee market supply and timely report significant changes to the NHSA. Failure to supply without justifiable reasons can lead to the drug being removed from the catalog and the enterprise being frozen from future NRDL adjustments for a period. Accurate and timely submission of sales and fund expenditure data is paramount, as this data directly informs renewal calculations.

Conclusion: A Landscape of Opportunity and Challenge

The 2025 NRDL adjustment presents a complex but structured pathway for pharmaceutical innovation in China. The introduction of the commercial innovative drug catalog offers a vital new channel for high-value therapies that may not immediately fit the basic insurance mandate, fostering a multi-layered payment system. For existing drugs, the refined renewal rules, particularly the shift to « payment scope expenses » and the « 4-year reduction by half » rule, demand sophisticated data analysis and strategic forecasting. Companies must prioritize robust internal data collection and analytical capabilities, engage proactively with the new digital submission process, and carefully assess the optimal entry/renewal strategy – whether dual submission, simplified renewal, or re-negotiation – to maximize patient access and commercial viability in this dynamic market. The focus remains on clinical value, innovation, and affordability, urging pharma to align their strategies with China’s evolving healthcare priorities.

Key Takeaways

• The 2025 medical insurance catalog adjustment officially launched on July 10, 2025.
• A commercial health insurance innovative drug catalog is established for the first time.
• The change prioritizes innovation, addressing clinical gaps, rare diseases, and pediatric drugs.
• Certain innovative drugs can apply to both basic and commercial catalogs.
• A new online system covers the entire catalog adjustment process.
• Simplified renewal rules were updated; « transfer to regular » conditions tightened.