Market Access China

The National Medical Products Administration (NMPA )(国家药品监督管理局) (formerly the China Food and Drug Administration, or CFDA) handles:

  • Regulatory approval
  • National pricing / reimbursement
  • Local negotiation or prescribing guidelines
  • Clinician prescribing decision for an individual patient

BIOMEDICINE

The National Reimbursement Drug List (NRDL) is the main public reimbursement mechanism in China, covering 98% of the entire population. China released its annual update of the NRDL list on December 3, 2021, which was implemented from January 1, 2022. A total of 74 drugs were added to the NRDL list and 11 were removed from it. 91% of the added drugs are new therapies reimbursed for the first time in China.

National Reimbursement Drug Listes
(NRDL)

The NRDL list refers to drugs covered by insurance plans that are fully or partially reimbursed by the state.
- Category A (614 types | 100% reimbursed): essential off-patent drugs with non-negotiable prices;
- Category B (2219 types | 65%-90% reimbursed): expensive new generation drugs, patented or recently off-patent, whose prices are negotiable;
- Category C (151523 types | 0% reimbursed): no reimbursement, such as dietary supplements, most imported drugs and special medicines.

Provincial Reimbursement Drug Listes
(PRDL)

Chinese provinces observe the NRDL by including products in their provincial reimbursable drug lists (PRDL). After receiving marketing approval, manufacturers can enter into negotiations with the provinces directly and be listed on their PRDL. The amount of the co-payment for drugs varies from province to province, which means that patients have to pay certain fees, depending on the plan adopted by each province.



MEDICAL DEVICE

Although Asia faces significant regulatory and operational risks, it is the fastest-growing market in the world. China is the most potential medical device market with $524 billion in sales by 2020. It is a promoter of great expansion, relying on its R&D and innovation capacity.

PRIMARY REGISTRATION REQUIREMENTS IN CHINA

1. The product should be classified as a medical device in China;

2. The medical device has been approved for sale and registred in the original country;

3. The applicant should have its representative office in China or designate a corporate legal person in China as its agent to cooperate relevant activities. Natural persons cannot apply for product registration as an agent, and the agent must be an enterprise legal person.

Dietary supplements

With the popularization of disease prevention concepts, the increase of the elderly population and the importance of personal health, the consumption capacity of health food is steadily increasing in China.

According to statistics, the annual growth rate of China’s dietary supplement industry is about 10-15%. The market size in 2021 exceeded $34 trillion, this is mainly for special products such as functional supplements (QS/SC) and special medical purpose supplements.

Registration of dietary supplements

In China, the NMPA states that dietary supplements refer to supplements that have been approved to have specific health functions (27 types) without adverse effects or for the purpose of supplementing vitamins and minerals. It should be noted that these products do not have a therapeutic purpose.


Dietary supplements are divided into two categories in China, one is functional supplements, and the other is nutritional supplements:

Functional supplements

Functional supplement refers to a health product with functions of skin care, immune system strengthening, and improvement of symptoms of a specific disease, etc. Depending on the type of food supplement, the period of the registration process varies from one to two years.

Nutrient supplements

Nutritional supplement refers to a product designed to provide extra vitamins and minerals. Its role is to supplement the lack of food intake, to prevent nutritional deficiencies and to reduce the risk of certain chronic degenerative diseases.