In recent years, the in vitro diagnostics (IVD) market has developed rapidly, and thanks to the impact of COVID-19 nucleic acid testing, the IVD industry has grown exponentially and a large number of enterprises have begun to venture into the industry. For industry practitioners, it's necessary to continuously learn related knowledge in this field. The development process of in vitro diagnostic reagents mainly includes several stages:
The preparation stage includes project survey, project evaluation, design input, etc. Firstly, the direction of the project needs to be determined, including the target to be tested, expected use, application scenarios, etc. Secondly, it's important to clarify market capacity and prospects, including disease incidence rates, analysis of competing products, and evaluation of the market after similar products have been launched, as well as clinical diagnosis or laboratory testing methods associated with such products. Once the direction is determined, a significant amount of literature and industry reports need to be reviewed to fully understand progress and applications in the target area, confirm the feasibility of the detection method and technology, as well as equipment environment requirements, staff roles and composition.
Once the project has been established, the development phase of in vitro diagnostic reagents can begin. The preliminary development phase includes screening of raw materials, research into the primary manufacturing processes and reaction systems, and product validation research.
When screening raw materials, at least three suppliers should be screened to ensure that the final supplier has a comprehensive quality system, and that raw materials can provide qualified quality standards, factory inspection reports and other materials.
In the research phase of the manufacturing process and reaction system, the dosage of the reagent, the proportion of various raw materials, reaction conditions, working temperature and other parameters are established. According to the R&D materials of raw material screening and manufacturing process and reaction system, corresponding documents are output, and the reagent production of GMP factory is carried out. This stage is the most critical stage, and it's also the stage where project progress most commonly deviates.
In the validation research stage, three batches of reagent kits produced in the GMP factory are used for product validation research, including product analytical performance evaluation, product stability research, determination of positive judgment values or reference intervals, and other related work.
After these stages are completed, it's time to enter the registration and testing phase, using samples of three batches of reagent kits produced continuously in the GMP factory to apply for registration inspection, and then conduct registration inspection. The materials in this stage will be summarized into the product registration report.
After receiving the registration test report, the clinical trial phase can begin, including preclinical preparation, formulation of clinical trial plans, signing of ethical clinical protocols, clinical trial registration, implementation of clinical trials, and summary of clinical trials.
After the clinical trial is completed, it enters the registration review phase, where the National Medical Products Administration evaluates the safety and effectiveness of the proposed in vitro diagnostic reagents and the results of their studies through the appropriate statutory procedures to decide whether to approve the application. This stage includes drafting and submitting IVD registration application materials, system assessments, and submitting supplementary materials based on notification letters.