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NMPA Guideline on Novel Coronavirus Antigen/Antibody Detection Reagent Issued


NMPA published Registration Guideline on Novel Coronavirus (Covid-19) Antigen/Antibody Detection Reagent on February 25, addressing the urgent needs of virus diagnostics. It is the second major regulation after the Guideline on Coronavirus Nucleic Acid Detection Reagent published on Feb 12.

Accelerated Approval

As of March 1, national NMPA granted 14 Emergency Approvals to Coronavirus diagnostics including 10 employing the nucleic acid method and 4 utilizing antibodies. Among them, it only took 4 days for the first four reagents to go to market.

In a separate notice, NMPA explains the timeline of Emergency Approval which include Nucleic Acid Detection Reagent, Antibody Detection Regent 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 centers to begin test in 1 day after receiving your testing samples.

Summary of Registration Guideline on Novel Coronavirus Antigen/Antibody Detection Reagent

  1. Application Scope

The guideline is for registration of antigen/antibody detection reagents for in vitro qualitative testing. Testing sample can be obtained from serum, plasma, whole blood, throat swabs, alveolar lavage fluid, sputum, or other respiratory secretions.

  • Performance Evaluation

Specific research methods, experimental schemes, experimental data and statistical analysis shall be included in the material. The following shall be focused on:

  1. Sample collection and processing
  2. Detection limit
  3. Verification of inclusivity of virus samples in different regions
  4. Specificity analysis
  5. IgM antibody detection reagent
  6. Precision
  7. Study on the hook effect
  8. Reference product verification
  9. Other matters needing attention (such as instrument’s performance evaluation)
  10. Applicable sample types
  11. Type Testing

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 has no national reference material, so applicant’s reference material should be used for type testing.

  • Positive Test Results Determination

Determination material includes specific test protocols, population and subject sample selection, evaluation criteria, statistical analysis, research data, etc. The selection of the sample source used to establish the positive judgment value should take into account the influence of different geographical regions, different infection stages and physiological conditions. The sample type differences should be verified.

  • Main Raw Materials

The main raw materials include antigens, antibodies, quality control products, and reference materials. Relevant research materials such as selection and source of main raw materials, preparation process, quality standards should be provided.

  1. If the main raw materials are self-made by the applicant, the detailed preparation process should be provided;
  2. If the main raw materials are outsourced, information should be provided including: the basis for selecting the raw materials and comparative screening test data, the quality standards provided by the supplier, the factory inspection report. The supplier shall not be changed.

The applicant shall define the quality control standards for each major raw material:

  1. Coronavirus-specific antigens and antibodies
  2. Other main raw materials
  3. Quality control kit and facility
  4. Reference product
  5. Production Processes and Reaction Systems
  6. Stability

Stability study includes two main areas:

  1. The reagent stability data: real-time stability, open-bottle stability, high-temperature accelerated stability, and transportation stability.
  2. The sample stability: the validity period under two conditions of refrigeration and frozen.
  3. Clinical Evidence

The clinical evaluation shall be conducted in at least three 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. Following materials shall be provided:

  1. Determination of clinical trial reference standard
  2. Clinical trial population
  3. Clinical trial sample types
  4. Clinical trial sample size
  5. Statistical analysis of clinical trial results
  6. Format requirements for clinical evidence

To accelerate market introduction, clinical evaluation can be conducted after market approval. Also, The Real-World Data and overseas clinical data can be used for clinical evaluation.

For four categories of urgently needed medical devices, please click HERE.

For an English copy of Guideline on Novel Coronavirus Antigen/Antibody Detection Reagent, please email us

China Med Device, LLC can help you obtain the Emergency Approval in China and put your reagents into the worst hit areas as soon as possible. We provide you with the following services:

  1. Identify the product codes
  2. Perform type testing report and conduct gap analysis between your standards and China ones.
  3. Register the products with national or provincial NMPA, whichever is more convenient
  4. Ensure smooth customs clearance
  5. Conduct post-market clinical trial, by your overseas clinical data or and Real-World Data in China, to supplement Conditional Approval

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