NMPA published Registration Guideline on Novel Coronavirus Nucleic Acid Detection Reagent today (Jan 12), addressing the urgent needs of virus diagnostics.
After issue of the Emergency Approval for Novel Coronavirus in January 20, seven Nucleic Acid Detection Reagent manufacturers have been granted approval. Among them, it only took four days for the first four reagents to go to market.
In a separate notice today, NMPA explains the timeline of Emergency Approvals which include those of Nucleic Acid Detection Reagent and a wide range of medical supplies:
- Class II Device
5-day technical review and 3-day administrative approval process
- Class III Device
10-day technical review and 3-day administrative approval process
The Notice also require testing center to begin test in 1 day after receptance of testing samples.
Summary of Guideline on Coronavirus Nucleic Acid Detection Reagent
The guideline is for registration of nucleic acid detection reagents for in vitro qualitative testing. Testing sample can be obtained from pharyngeal swab, nasopharyngeal swab, alveolar lavage fluid, sputum, respiratory tract lotion, aspirate, and other respiratory secretions.
Specific research methods, experimental schemes, experimental data and statistical analysis shall be included in the performance evaluation material. The following shall be focused on:
- Nucleic acid (RNA) extraction / purification performance
- Lowest detection limit
- Verification of inclusiveness of virus samples in different regions
- Analytical specificity
- Provide verification information of enterprise reference products
Type testing shall be conducted at certified testing center; Testing report shall comply with PTR (product technical requirement); 3 batches of testing report shall be provided.
The product already has a national reference material, and the material should be used for type testing.
Determination of Positive Test Results
Determination material mainly refers to the data for confirming the Ct value of the virus nucleic acid test of the product, that is, the critical value of the result judgment. When choosing the sources of determination material, wide range of factors shall be considered, such as different ages, genders and regions, with diversity and representativeness. If there is a gray area with a judgment value, the confirmation data of the gray area shall be provided. The rationality of the selected positive judgment value research method should be explained, and the threshold setting should be scientific and reasonable. Provide the determination method and research data of internal standard value.
Main Raw Materials
The main raw materials of this product include primers, probes, enzymes, dNTPs, nucleic acid isolation / purification components (if any), quality control materials, reference materials, etc. Relevant research materials, such as the selection and source of main raw materials, preparation process, quality standards, quality control test data, etc. shall be provided. If the main raw materials are self-made by the enterprise, the detailed preparation process should be provided; if the main raw materials are sourced from outsourcing, information should be provided including: the basis for selecting the raw materials and comparative screening test data, the quality standards provided by the supplier, and factory inspection reports and quality inspection data after the raw materials arrive.
Main Production Processes and Reaction Systems
Stability Study Data
The stability research data mainly involves two parts, the stability of the declared reagent and the stability of the applicable sample.
The clinical evaluation shall be conducted in three or more clinical trial institutions (including the CDCs at all levels); the test results from clinical case samples and similar products already on the market shall be compared with the intended reagent. It is recommended that the kits of multiple manufacturers be jointly verified in the same clinical trial institution.
- Clinical trial comparison method
- Clinical trial population
- Clinical trial sample types
- Clinical trial sample size
- Statistical analysis of clinical trial results
- Format requirements for clinical evidence
For complete English version of the guideline, please email info@ChinaMedDevice.com.
We can help you identify the product codes, submit type testing report if needed, register the products with right provincial NMPA, and ensure smooth customs clearance.
About ChinaMed Device, LLC
ChinaMed Device, LLC (www.ChinaMedDevice.com) provides regulatory and commercialization turnkey solutions for medical device, IVD, CDx and combination products in China. As a qualified NMPA (CFDA) legal representative with offices in Boston and Beijing, we can represent manufacturers for the complete product life cycle without their need to create a local entity in China. Our NMPA (CFDA) regulatory services include strategy, registration, local type testing, product technical requirement (PTR), clinical evaluation report (CER), clinical trial, GMP and post-market surveillance (AE, recall, inspection, etc.). Our commercialization services include market research, reimbursement, partnership strategy and distribution qualification.