In vitro diagnostic products that were included in the special approval and priority approval procedures

Medical Network June 7th News As of May 31st, 2018, CMDE publicity shows that 183 products have been included in the special approval channel for innovative medical devices, of which 37 are in vitro diagnostic products, accounting for 16.94% of the total number of products; The products were included in the medical device priority approval channel, of which 6 were in vitro diagnostic products, accounting for 40% of the total number of products.

According to "Innovation medical instruments "Special Approval Procedures" (Food and Drug Administration, No. 13 of 2014) stipulates: Innovative medical device products must comply with the main working principles/mechanisms of action in China, and product performance or safety have a fundamental improvement over similar products. Technically, At the international leading level, and has significant clinical application value.

Among the 37 products publicized, there were 31 in vitro diagnostic reagents and 6 in vitro diagnostic instruments. Among them, molecular diagnostic products dominated with an absolute advantage of 89%, including 29 molecular diagnostic reagents and 4 molecular diagnostic instruments. 1 biochemical diagnostic reagent, 1 immunodiagnostic reagent, 1 immunodiagnostic instrument and 1 biochemical immune instrument were included in the special approval channel.

According to the “Priority Approval Procedure for Medical Devices” (General Administration Bureau Announcement No. 168 of 2016): Priority is given to the implementation of medical devices that meet one of the following conditions:

(i) Medical devices that meet one of the following conditions:

1. Diagnose or treat rare diseases and have obvious clinical advantages;

2. Diagnose or treat malignant tumors with obvious clinical advantages;

3. Diagnosis or treatment of elderly people with unique and multiple disease , And there is no effective diagnosis or treatment at present;

4. Dedicated to child , And has obvious clinical advantages;

5. Urgent clinical needs, and there is no medical device that is approved for registration in the same product in China.

(2) Medical devices that have been listed in national major science and technology projects or national key R&D plans.

(3) other medical devices that should be given priority for approval.

Among the six publicly-listed products, five are products that meet the above-mentioned condition II' medical equipment listed in major national science and technology projects or national key R&D programs, and one item meets the above conditions, 'diagnosing or treating rare diseases, and have Significant clinical advantage'; 4 are immunodiagnostic products, 2 are molecular diagnostic products.

The current in vitro diagnostic market in China is mainly divided into three categories: biochemistry, immunity, and molecular. Compared to biochemical and immunological diagnostics, molecular diagnostics have higher sensitivity, greater specificity, and higher technical barriers. These have received special approvals. The products that are approved or prioritized are all products that are at the international advanced level or even fill the gaps in the domestic market. Under the circumstances of large-scale development and great changes, technological upgrading will continue to change existing medical technologies. enterprise Rushed to the forefront, especially priority review and approval of applications in the enterprise there are 14 companies with no marketed products, the company has only 8 1-2 products have been listed.

Among them, Xiamen Aide Bio medicine LTD. Product human EGFR mutation detection kit (fluorescence multiplex PCR method) from March 7, 2017 to the public January 18, 2018 granted lasted less than 11 months, the product is based on the amplification refractory mutation system (Amplification Refractory Mutation System, ARMS) and Fluorescent PCR to Detect 6/18 EGFR Mutant Genes in Plasma DNA Samples. Aide Biosciences has obtained a product of 21 mutation detection kits (fluorescence PCR) for the human EGFR gene in 2010. Registration Certificate for the in vitro qualitative detection of 21 somatic mutations of DNA extracted from pathological specimens of patients with colorectal cancer and lung cancer. The Human EGFR Gene Mutation Detection Kit (Multiplex Fluorescence PCR) is used to qualitatively detect advanced non-small cell lung cancer in vitro ( NSCLC) Human EGFR mutated gene in patient's plasma DNA sample. Compared with the former, it can only be used for auxiliary diagnosis. The latter is China's first approved companion test for autirinib mesylate. It is clinically applicable. Provide clear guidance for doctors.

Shenzhen Jinbaihui Biological Co., Ltd. product miR-92a gene expression level detection kit (fluorescent RT-PCR method) from June 6, 2016 to March 27, 2018, approved for nearly 22 months, the product The RNA extraction kit was used to extract the RNA from feces for RT-PCR reaction. The primers in the reaction were able to bind specifically to miR-92a reverse transcription products and perform PCR amplification. During the amplification process, the After the reverse transcribed cDNA strand containing the miR-92a template is complementarily combined, the fluorescent dye group on the 5′ end of the probe is cut by the Taq enzyme and releases a fluorescence signal. The intensity of the detected fluorescence signal can reflect the content of miR-92a in the sample. The product is used to qualitatively detect miR-92a nucleic acid in human fecal samples in vitro. miR-92a is a new marker for the detection of colorectal cancer. The product collection is convenient, the detection time is short, and it has high clinical value.

As a whole, the number of products is on the rise and concentrated in the field of molecular diagnostics. However, not all products that incorporate the green channel have been successfully reviewed. Currently, only 14 products have been listed on the market, accounting for only 32.56% of the total. Related companies need to be fully prepared to ensure that the declared product has been fully identified before it can be successfully approved for listing.