China's most recent NRDL update

Key learnings following China’s most recent NRDL update



In December 2021, China once again updated its National Reimbursed Drugs List (NRDL) and in line with industry expectations, expanded further to include more innovative and rare disease products. Now that the updates have been implemented, and the dust has settled, it’s time for manufacturers to take stock of the recent changes and begin considering what this means for China from a market access perspective. Building on Simon-Kucher’s recent analysis, we outline the key updates to the 2021 NRDL and discuss what this is showing about the Chinese market.

Summary of the updates:

In December of last year and following its commitment to update the list annually, China released its finalised NRDL.

  • The update included 74 new inclusions which spanned across oncology, antiviral, cardiology, rare disease, and immunology
  • Out of the 172 new entries which passed the formal review stage and progressed to negotiations, 34 were oncology products. The average success rate for passing formal review in oncology was 53%
    • Antiviral products secured the highest average success rate with 73% of products passing the review stage and progressing to negotiations, a by-product of COVID-19 and China’s efforts to increase vaccine rollouts
  • A total of 20 rare disease drugs passed the formal review stage, however only 7 new additions made it onto this year’s list
    • The average time taken from launch in China to NRDL inclusion for these 7 additions averaged at just 18 months, a remarkable 80% decrease from the 2019 average of 87 months. This sharp decrease in negotiation timelines may also be a by-product of the pandemic, as China aims to get its anti-viral products to patients faster and which products from other therapy areas are able to leverage

As a result of these annual expansions, the NRDL formulary now stands at 2,860 drugs — up from 2,588 in 2017, showcasing a continued commitment from the authorities to create a greater level of access for both Chinese patients and manufacturers.

What does this show about the market?

Increasing innovation

The first and foremost important factor that these updates show is China’s ongoing emphasis and commitment to reimburse innovative medicines, an undertaking that has been looming in the background in China for several years now. Further evidence of this commitment is shown through China’s expansion into ‘home-grown’ innovation. For example, it’s rapid expansion of the BioBAY district in Suzhou, an emerging hub for biopharma and now home to over 430 businesses including big name players like Innovent Biologics, CStone Pharmaceuticals, and BeiGene. In addition, regulatory reforms are constantly ongoing to support faster development and approvals of innovative drugs. Reforms span across all corners of the market, from regulation to on-the-ground business support and demonstrate China’s openness for innovative products and it’s widening market access pathway for innovators in the field.

Increased transparency

In addition to faster access for innovative medicines, China is also demonstrating an increased degree of transparency in its NRDL decision making and, for the first time in history the submission materials of the 271 successful applications which passed the formal review stage were made public (note that of these 271 applicants, 99 were up for renewal and not classed as new entries). Historically, understanding the decision process to secure access to the NRDL has been notoriously challenging and seemingly haphazard. This new move towards open and transparent decision making removes some of the historic access challenges previously faced by many manufacturers.

Openness for high priced therapies

The final key takeaway following last year’s update is the increased openness from Chinese health officials for high-priced therapies, especially high-cost cancer, and rare disease therapies. This is perhaps to better treat China’s aging population, a market characteristic which brings higher cases of complex cancers that require innovative treatment options. China is also increasing the number of alternative access options open to manufacturers and Direct to Patient (DTP) financing, Critical Disease Insurances (CDI) and Commercial Health Insurances (CHI) are all playing increasingly important roles in improving access and affordability. Routes such as this may therefore provide access alternatives for manufacturers less willing to reduce product prices to gain NRDL inclusion.


To conclude, this year’s NRDL expansion supports the ever-growing notion that China is becoming one of the most important markets for innovative therapies. However, challenges remain and as the rare disease and oncology space becomes more crowded year on year, manufacturers will need to strive for greater degrees of innovation and differentiation from competitors going forward.


  1. National Healthcare Security Administration. The Ministry of Human Resources and Social Security of the National Medical Insurance Administration issued the 2021 edition of the National Medical Insurance Drug Catalogue. December 3rd Accessed February 10th 2022. Available at:
  2. China 2021 National Reimbursement Drug List Outlook. November 11th 2021. Accessed February 10th 20200. Available at:

Stay in the know, subscribe to our newsletter

Be the first to receive exclusive content on the latest from the pharmaceutical and market access sector.