What Is China's National Reimbursement Drug List (NRDL)?

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The National Reimbursement Drug List (NRDL) is a cornerstone of China's healthcare system, determining which pharmaceuticals are eligible for reimbursement under the country’s Basic Medical Insurance (BMI) scheme. Managed by the National Healthcare Security Administration (NHSA), the NRDL aims to balance patient access to essential medications with the sustainability of public healthcare finances.

What Is the NRDL?

Established to streamline drug access and control healthcare costs, the NRDL categorizes medications into three primary groups:

  • Category A: Essential drugs with high clinical value and cost-effectiveness.
  • Category B: Drugs that are clinically necessary but may have higher costs or limited availability.
  • Category C (introduced in 2025): Innovative treatments with significant clinical benefits that may be costlier and are subject to special pricing or conditional access.

Each year, the NHSA conducts a rigorous review process involving expert evaluations and price negotiations to decide which drugs will be added or removed. This process ensures the NRDL reflects the latest in medical innovation while maintaining economic efficiency.

Latest Update: NRDL 2025

The 2025 NRDL, effective from January 1, 2025, brought several important changes:

  • Introduction of Category C: This new category allows inclusion of high-cost, high-benefit drugs, particularly innovative therapies that were previously excluded due to pricing concerns.
  • Expanded List: A total of 91 new drugs were added, bringing the total to 3,159. Of these, 90 were introduced within the past five years, and 38 were globally innovative.
  • Support for Domestic Innovation65 of the newly added drugs were developed in China, showcasing growing domestic pharmaceutical capabilities.
  • Aggressive Price Negotiations: The NHSA negotiated prices for 117 off-list drugs, with 89 gaining inclusion, and average price cuts reaching 63%.

Why the NRDL Is Important for Pharmaceutical Companies

The NRDL is not just a healthcare policy tool — it’s a strategic gateway for pharmaceutical companies aiming to enter and grow in the Chinese market. Here's why:

  • Market Access and Expansion: Being listed on the NRDL dramatically increases a drug’s potential market size by making it eligible for reimbursement under China's national insurance scheme. This can exponentially boost sales volumes.
  • Enhanced Patient Reach: Inclusion ensures affordability and accessibility for patients, particularly for high-cost therapies, making innovative treatments more widely adopted.
  • Commercial Viability: For many drugs, especially those treating chronic or serious illnesses, NRDL inclusion is a prerequisite for success in China due to the significant out-of-pocket costs otherwise faced by patients.
  • Brand Recognition and Trust: Listing on the NRDL often elevates a company's brand profile in China, signaling approval by health authorities and boosting prescriber and patient confidence.
  • Regulatory  Leverage: Success in NRDL negotiations can provide leverage in other global markets by demonstrating cost-effectiveness and local market value.

In short, the NRDL is a critical factor in the long-term commercial success of pharmaceutical products in China. Companies that understand and align with its evolving framework are better positioned to thrive in one of the world’s largest and fastest-growing healthcare markets.

Bringing medicines to the Chinese market means following complex and detailed regulations. From product registration and clinical trials to packaging, safety, and labeling — companies must comply with strict government rules.

Freyr helps pharmaceutical companies understand and meet all these Regulatory  requirements. Whether you're launching a new product or managing changes to an existing one, Freyr makes the process smoother and faster.

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