121 kinds of medical equipment related to rare diseases.

Medical Network May 24th Recently, the National Health and Sports Commission, the Ministry of Science and Technology, the Ministry of Industry and Information Technology, the Food and Drug Administration, and the Administration of Traditional Chinese Medicine jointly issued the "First List of Rare Diseases," a total of 121 diseases listed.

With the concerted efforts, the national rare disease list has finally come out and disease related drug with medical instruments , Based on existing policies, it will directly benefit greatly in the future.

As early as October 2016, the former State Food and Drug Administration issued the "Priority Approval Procedure for Medical Devices", which stipulates that priority will be given to the approval of several types of medical devices as of January 1, 2017.

Products that enter the priority approval process can be listed on the market in a very short period of time. The one that can enjoy priority approval is: Diagnose or treat rare diseases. Cancer And has obvious clinical advantages of medical equipment.

In October 2017, the China Affairs Office and the State Council issued the "Opinions on Deepening the Reform of Review, Approval, and Approval System to Encourage the Innovation of Drugs and Medical Devices." This high-profile and heavy document further proposes: Support for R&D of medical devices for the treatment of rare diseases. The Commissioner may entrust the relevant industry associations to publish the list of rare diseases and establish a registration system for rare patients. Applicants for the registration of medical devices for the treatment of rare diseases may apply for a clinical trial for reduction or exemption. Therapeutic medical devices may be approved for listing with conditions attached. enterprise A risk management plan should be developed to conduct research as required.

The so-called rare disease is also called 'orphan disease', with a low incidence and a small proportion of patients. However, under the large base of China's 1.3 billion population, the market size will not be small. The data of the Center for Birth Defects Research of Fudan University once claimed that China The number of rare diseases is about 16.8 million.

WHO, Europe, the United States, Japan, etc. all have official definitions of rare diseases. There are also related bills for rare diseases, supportive policies, etc. And China has not clearly defined rare diseases before. Although there is a folk version of the 'Chinese rare disease reference catalog', there is no official one. Edition directory, lack of research on rare diseases diagnosis and treatment products, lack of support policies, most of the rare disease products abroad have not entered the domestic market.

However, China is working hard to fill gaps in the field of rare disease diagnosis and treatment. Accelerating R&D and listing of rare disease-related products has been introduced in succession. Market expansion of rare disease products has made a good start.

This time, the five national departments released a list of rare diseases of the national version, clearly defined the definition of rare diseases, and the country’s supportive policy was further advanced. It also gave guidance to people in the industry.