China’s National Reimbursement Drug List (NRDL) is the single national catalog of medications covered by the country’s basic medical insurance, which enrolled more than 1.33 billion people as of late 2025. The National Healthcare Security Administration (NHSA) manages the list, negotiates prices with manufacturers, and sets the cost-sharing rules that determine what patients pay at the pharmacy counter.1Journal of Market Access & Health Policy. Access to Innovative Drugs and the National Reimbursement Drug List in China: Changing Dynamics and Future Trends in Pricing and Reimbursement Since the NHSA was created in 2018, the NRDL has replaced the fragmented provincial channels that came before it and now functions as the primary procurement guide for public hospitals nationwide.
What Patients Pay: Category A and Category B
The list is split into two tiers under the Interim Measures for the Administration of Drugs for Basic Medical Insurance, issued in 2020.
Category A covers drugs that are clinically necessary, widely used, and relatively affordable. These carry a zero copayment ratio, meaning the insurance fund pays the full cost and patients owe little or nothing.2Intractable & Rare Diseases Research. Should Annual Cost of the Drug Inform Reimbursement Decisions? A Quantitative Analysis Based on China’s National Reimbursement Drug List Common antibiotics, basic pain medications, and standard acute-care treatments sit in this tier. The Category A list is set uniformly by national authorities, with no local variation permitted.
Category B covers drugs that are still clinically effective but more expensive. Before regular insurance cost-sharing applies, patients pay an initial copayment that typically runs 10% to 30% of the drug’s price, though most cities set it at 10% or lower depending on local fund balances.2Intractable & Rare Diseases Research. Should Annual Cost of the Drug Inform Reimbursement Decisions? A Quantitative Analysis Based on China’s National Reimbursement Drug List The remainder then enters the standard reimbursement process, where the fund covers a share and the patient pays the rest. Total out-of-pocket burden varies significantly by region, from around 20% in wealthier provinces to as high as 45% in less-developed areas once all layers of cost-sharing are counted.3National Bureau of Economic Research. A Double Dose of Reform: Insurance and Centralized Negotiation in Drug Markets Drugs added through the annual price negotiation process are folded into Category B for administrative purposes and stay there for the duration of their agreement.
How a Drug Gets on the List
A drug must clear several requirements before the NHSA will consider it. First is marketing authorization from the National Medical Products Administration (NMPA), and the product must be licensed and actively marketed in China by a cutoff date the NHSA sets in each year’s working plan.1Journal of Market Access & Health Policy. Access to Innovative Drugs and the National Reimbursement Drug List in China: Changing Dynamics and Future Trends in Pricing and Reimbursement That date shifts between review cycles, so manufacturers watch each announcement closely.
The core evaluation is clinical value. Manufacturers submit dossiers with head-to-head trial data and comparative effectiveness evidence showing how the drug performs against whatever is already on the list for the same condition. Products that address unmet needs or clearly improve on existing treatments receive priority. The NHSA also weighs budget impact, requiring pricing data and sales projections to model what the drug would cost the fund at scale.
Manufacturers must also show they can supply the drug consistently across the country. The NHSA reviews the company’s regulatory compliance history, and major safety violations can disqualify a drug regardless of its clinical profile.
Priority for Rare Disease and Pediatric Drugs
Since 2022, rare disease drugs approved by the NMPA have been listed as a separate category within the NRDL adjustment scope, with preferential weighting during review. Higher willingness-to-pay thresholds apply in pharmacoeconomic evaluations for pediatric drugs, rare disease treatments, end-of-life therapies, and first-in-class medicines. A 2025 regulatory reform document called for accelerated review of rare disease drugs, including clinical trial exemptions for eligible innovative therapies and priority review for urgently needed cell and gene therapies.4Intractable & Rare Diseases Research. Health Technology Assessment and Medical Insurance Access for Rare Disease Drugs in China: A Policy Review with Quantitative Insights from Publicly Available Data
How Prices Are Negotiated
For new entries, especially innovative or expensive therapies, the NHSA negotiates directly with manufacturers rather than setting prices by decree. Expert panels of clinicians, pharmacoeconomists, and insurance fund managers establish an internal ceiling price based on the drug’s clinical benefit and budget impact.5ISPOR. China’s National Reimbursement Drug List (NRDL) Negotiation: Value Considerations and Key Factors Influencing Payment Standards
Sessions operate under tight confidentiality. The company submits its best price offer, which the NHSA compares against the internally calculated value. If the bid falls within a set margin of the government’s ceiling, the two sides negotiate toward a final figure. If it doesn’t, the drug is out for that cycle. Initial listing negotiations have historically produced price reductions exceeding 60% off the launch price for high-cost therapies. The ceiling itself draws on cost-per-quality-adjusted-life-year analysis, typically using a willingness-to-pay threshold of 0.5 to 1.5 times GDP per capita, a far lower bar than manufacturers face in the United States or Europe.
Renewal and Renegotiation
Negotiated price agreements last for a fixed period, after which the drug must go through renewal to stay on the list.6National Center for Biotechnology Information (NCBI). Impact of Six Rounds of National Drug Price Negotiation on Availability and Affordability of Negotiated Drugs in China The process splits into two tracks.
Simple renewal lets drugs extend their NRDL status without a full price renegotiation, provided actual budget impact has stayed within the expectations the NHSA set during the original negotiation. In the 2025 round, 148 drugs were eligible for simple renewal, and 133 passed with no price cut.7Simon-Kucher. 2025 NRDL Readout: New Listings, Renewals, and Re-Negotiations
Drugs that overshoot budget projections or face shifted competitive dynamics go through full renegotiation. The NHSA uses real-world sales and expenditure data to set a new baseline.1Journal of Market Access & Health Policy. Access to Innovative Drugs and the National Reimbursement Drug List in China: Changing Dynamics and Future Trends in Pricing and Reimbursement In 2025, 30 drugs went through renegotiation with an average price cut of 14%, up from 12% the prior year.7Simon-Kucher. 2025 NRDL Readout: New Listings, Renewals, and Re-Negotiations Drugs that fail renegotiation are removed from the list.
What the List Covers
As of the 2025 update, the NRDL contains over 3,100 drugs spanning chemical medicines, biologics, and traditional Chinese medicines. The 2025 round alone added 91 new products.8PharmaDJ. China’s National Reimbursement Drug List (NRDL): Structure and Coverage
A large share of the list addresses the chronic conditions driving healthcare spending in an aging population: hypertension, diabetes, cardiovascular disease, and respiratory and metabolic disorders. Oncology has become the most closely watched therapeutic area. Of 60 cancer drugs that passed formal review for the 2025 list, 36 made it to final listing. Notable additions included KRAS G12C inhibitors for lung cancer, multiple CDK4/6 inhibitors for breast cancer (four new entrants competing against four incumbents), and next-generation PARP inhibitors for ovarian cancer.7Simon-Kucher. 2025 NRDL Readout: New Listings, Renewals, and Re-Negotiations Listing targeted therapies and immunotherapies such as PD-1/PD-L1 inhibitors absorbs financial shocks that cancer treatment would otherwise impose on individual families.
Traditional Chinese Medicine has a permanent place on the list alongside Western pharmaceuticals, covering prepared medicines, herbal decoctions, and injectable formulations. Rare diseases receive targeted coverage through the preferential review pathway, with several orphan drugs added for small but vulnerable patient populations. Infectious diseases including hepatitis and HIV/AIDS are also comprehensively addressed, with coverage extending to antivirals needed to prevent the spread of communicable illness.
Getting a Listed Drug Is Not the Same as Getting the Drug
Public hospitals, where most prescribing happens, face internal constraints that can block access to newly listed drugs even after the NHSA has approved them. Global budget controls, hospital formulary limits, and drug expenditure ratios all create pressure against stocking expensive new therapies. Even after a drug joins the NRDL, the hospital’s pharmacy and therapeutics committee must complete its own formulary review, a process that can take months.9National Center for Biotechnology Information (NCBI). Analysis of Nationwide Availability of Negotiated Drugs in China’s National Reimbursement Drug List
The NHSA and the National Health Commission established a Dual-Channel Management Mechanism in 2021 to address this bottleneck. Under the policy, patients can fill prescriptions for negotiated drugs at designated retail pharmacies using their medical insurance, rather than relying only on hospital pharmacies. Designated pharmacies must meet specific standards: dedicated counters for negotiated drugs, licensed pharmacists on staff, insurance billing integration, and proper storage for specialized formulations.9National Center for Biotechnology Information (NCBI). Analysis of Nationwide Availability of Negotiated Drugs in China’s National Reimbursement Drug List
The mechanism helps but hasn’t closed the gap. Hospitals often refuse to administer injectable drugs that patients purchase from outside pharmacies, citing quality control and safety concerns. The pharmacies themselves face financial strain: a zero-markup policy keeps retail prices low while infrastructure and cold-chain costs run high. As of late 2025, tertiary hospitals stocked an average of only about 10% of all negotiated drugs on the list.9National Center for Biotechnology Information (NCBI). Analysis of Nationwide Availability of Negotiated Drugs in China’s National Reimbursement Drug List What the NRDL covers on paper and what a patient can obtain at a local facility remain two different things.
The Annual Update Cycle
The NHSA updates the list on a structured annual schedule. Each year the agency publishes a working plan setting out the timeline for data submission, expert review, and negotiation sessions. The process also includes an exit mechanism: drugs can be removed if the NMPA revokes their marketing authorization, if significant safety concerns emerge, or if clinically superior and more cost-effective alternatives make them obsolete.
After negotiations wrap up, the NHSA announces the updated list, typically toward the end of the calendar year. The 2025 NRDL took effect on January 1, 2025. Local healthcare bureaus then ensure that public medical institutions implement the new prices and reimbursement rules, and the government publishes data on drugs added, average price reductions, and prioritized therapeutic areas ahead of the next cycle.