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.
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:
5-day technical review and 3-day administrative approval process
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.
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.
Specific research methods, experimental schemes, experimental data and statistical analysis shall be included in the material. The following shall be focused on:
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.
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.
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.
The applicant shall define the quality control standards for each major raw material:
Stability study includes two main areas:
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:
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 info@ChinaMedDevce.com.
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: