In recent years, the in vitro diagnostic market has developed rapidly, especially since 20 19. Due to the influence of nucleic acid detection in novel coronavirus, the in vitro diagnostic industry has developed rapidly. In vitro diagnostic kit is the main product of in vitro diagnosis. The research and development of in vitro diagnostic reagents mainly includes the following links:
1, project preparation stage
Including project investigation, project evaluation, design input, etc. First of all, we need to determine the direction of the project, including the target to be tested, the expected use, the application scenario and so on. The second is to clarify the market capacity and application prospects, including the incidence of corresponding diseases, and whether there are similar products in the market, that is, competitive products. And clarify the market evaluation of similar products after listing and related clinical diagnosis or laboratory testing methods. After determining the direction, it is necessary to consult a large number of documents and industry reports, fully understand the research progress and application of the target, confirm the feasibility of the detection method and technology, and confirm the environmental conditions of the equipment, the functions and composition of the project developer, etc.
After the project is approved, enter the product design. When designing the input, we must consider everything as much as possible, determine the performance parameters and standards of the product, make clear the expected use, and avoid finding many defects when outputting. The information at this stage will be summarized in the file when the product is registered and declared, that is, the product summary information.
2. Product development stage
After the project is completed, the research and development stage of in vitro diagnostic reagents can be started. The early stage of development includes raw material screening, main production technology and reaction system research, and product verification research;
(1) When screening raw materials, at least three suppliers should be screened, and the finally selected suppliers should be guaranteed to have a sound quality system, and raw materials can provide qualified quality standards, factory inspection reports and other materials.
(2) In the research stage of production technology and reaction system, the parameters such as reagent dosage, the ratio of various raw material formulas, reaction conditions, working temperature and so on are determined. According to the research and development data of raw material screening, production technology and reaction system research, the corresponding documents are output and the kit is produced in GMP workshop. This stage is the most important stage, and it is also the stage where the project schedule often deviates.
(3) In the verification research stage, three batches of kits produced by GMP factory are used for product verification research, including product analysis performance evaluation, product stability research, positive judgment value or reference interval determination and other related work.
3. Registration check stage
After the above stage is completed, you can enter the registration inspection stage, apply for registration inspection sampling with three batches of kits continuously produced by GMP factory, and then carry out registration inspection and verification. The data at this stage will be summarized in the file when the product is registered and declared, that is, the registration test report.
4. Clinical trial stage
After you get the registration test report, you can start the clinical trial stage. The clinical trial stage includes pre-clinical preparation, making clinical trial plan, signing ethical clinical agreement, clinical trial filing, clinical trial implementation and clinical trial summary. The data at this stage will be summarized into the documents when the product is registered and declared, that is, the clinical trial plan and clinical trial report.
5. Registration review stage
After the clinical trial is completed, the registration review stage is a process in which the State Administration of Medical Supplies systematically evaluates the safety and effectiveness research and results of IVD reagents to be marketed according to the application of registered applicants and corresponding legal procedures, so as to decide whether to approve their applications. This stage includes the preparation and submission of IVD registration application materials, system evaluation, corresponding issuance and supplementary work according to the issuance and supplementary notice, and submission of issuance and supplementary materials. After all the above audits are passed, the certificate can be obtained. The data at this stage will be summarized into documents required for product registration, such as quality system evaluation report. After registration, the certificate can be obtained, and the kit is successfully developed and registered.
2. What are the difficulties in the development of in vitro diagnostic kit?
The development of in vitro diagnostic kit is not so simple, and there are many difficulties in the development process, including:
1. First, we should find some patients with the same disease, and then we should start looking for disease-specific signals through basic scientific research. These signals can distinguish patients and normal people qualitatively or quantitatively, and can also distinguish other similar diseases. This is the difficulty in the initial stage of research and development.
2. It is not enough to find this signal that can be used for diagnosis. It is also necessary to develop a method that can repeatedly identify this signal qualitatively and quantitatively. The best way is to make the materials convenient, accurate, fast, light and cheap, which is the difficulty in the research and development process.
3. To enter the market after research and development, it needs production, clinical verification, examination and approval, doctor-patient education and marketing.