Ministry of agriculture and rural areas revises "veterinary diagnostic products registration classification and registration data requirements"

Three days before the standard use of veterinary drugs by the Ministry of agriculture and rural areas

Included in topic

#Regulation 1

#Registration 1

In order to further improve the enthusiasm for the development of veterinary diagnostic products, promote commercial production and application, improve the quality of products, and further meet the needs of diagnosis and monitoring of animal diseases, our ministry has organized and revised the "requirements for registration classification and registration data of veterinary diagnostic products", which is hereby issued and will come into effect on October 15, 2020. The relevant matters are announced as follows.

1、 Veterinary diagnostic products included in veterinary drug registration management only refer to diagnostic products for animal epidemic disease diagnosis or immune monitoring.

2、 Since October 15, 2020, the new application for registration of veterinary diagnostic products should be submitted by enterprises with corresponding GMP conditions and pilot production or jointly with other research units. The new veterinary drug registration certificate shall be issued for the innovative veterinary diagnostic products that meet the registration requirements after evaluation; the production process, quality standards, labels and instructions of the improved veterinary diagnostic products that meet the registration requirements shall be approved and issued by the pilot production enterprise according to the situation specified in Article 6 of the administrative measures for approval number of veterinary drug products The approval number of the product shall be exempted from the requirement of submitting the registration certificate of new veterinary drugs.

3、 The requirements for clinical trial management of veterinary diagnostic products in vivo are the same as those for prophylactic and therapeutic veterinary biological products. The clinical trials of in vitro veterinary diagnostic products do not need to be approved, and the relevant clinical trial units do not need to report and accept the supervision and inspection of GCP of veterinary drugs

4、 Veterinary diagnostic products that have been applied for before October 15, 2020 shall be implemented according to the original registration data requirements.

It is hereby announced.

Appendix: veterinary diagnostic products registration classification and registration data requirements

                                                            Ministry of agriculture and rural areas

September 29, 2020

enclosure

Registration classification and registration data requirements of veterinary diagnostic products

1、 Registration classification

Innovative veterinary diagnostic products: veterinary diagnostic products developed by new diagnostic methods for the first time, with clinical value and not marketed in China.

Improved veterinary diagnostic products: compared with veterinary diagnostic products which have been sold in China, the veterinary diagnostic products have improved in sensitivity, specificity, stability, convenience or applicability.

2、 Registration information items and their descriptions

（1） General information

1. Name of diagnostic product. Including common name and English name.

The general name should be in accordance with the "naming principles for veterinary biological products".

2. Supporting documents.

(1) Documentary evidence of the applicant's legal registration.

(2) A guarantee that the intellectual property rights of others do not constitute infringement.

(3) If highly pathogenic animal pathogenic microorganisms are used in the research, copies of approval documents related to the examination and approval of experimental activities shall be provided.

3. Production process procedures, quality standards and drafting instructions, with standard operation procedures for main finished product inspection items attached.

4. Sample text of instructions and labels.

5. Innovative description shall be provided when applying for innovative veterinary diagnostic products.

（2） Research data of bacteria (virus, insect) species or other antigens for production

6. Sources and characteristics. Data, data, or purely biological characteristics, including the nature of the study, the purity, etc.

7. If synthetic peptide or expressed product is used as antigen, the basis of antigen selection should be provided.

8. For molecular biological products, the selection basis of primers and probes should be clarified.

（3） Sources, quality standards and inspection reports of main raw and auxiliary materials

9. For the raw and auxiliary materials used in production, such as cells, monoclonal antibodies, serum, nucleic acid materials, enzyme labeled plates, enzyme labeled antibodies, enzymes and other raw and auxiliary materials, the sources shall be identified, the enterprise standards shall be established, and the inspection report shall be submitted. If there are national standards, they shall meet the requirements of national standards.

（4） Production process research data

10. Main manufacturing materials, components, formula, process flow and research data of production process.

(1) Preparation and test report of antigen, antibody, nucleic acid and polypeptide.

(2) Preparation and test report of negative and positive control substance.

(3) Product composition, formula and assembly process.

（5） Quality control sample preparation, testing, calibration and other research data

11. Research, preparation, inspection, calibration and other data of quality control samples used for finished product inspection. It includes inspection standard, inspection report, calibration method and calibration report. If international or national standards / reference materials are used as quality control samples, only the source certification materials are required.

（6） Product quality research data

12. Btch number, batch number and batch number of products used for various quality studies, signature of test director and executor, test time and place.

13. The establishment of diagnostic methods and the research data of the optimal conditions.

14. Sensitivity study report. It includes the positive rate and the minimum detection quantity (sensitivity) of the known weak positive and positive samples. If the test object contains multiple serotypes / genotypes, the Research Report on the detection of major epidemic serotypes / genotypes should be provided.

15. Specificity study report. It includes the negative rate of known negative samples, antigen or antibody samples with cross reaction.

16. Repetitive Research Report. Inter and intra assay repeatability studies of at least 3 batches of diagnostic products.

17. Storage life test report of at least 3 batches of diagnostic products.

18. Research Report on coincidence rate. Test report compared with other diagnostic methods.

19. For in vivo diagnostic products, safety research reports on chemical residues and adverse reactions of 3 batches of products to target animals should be provided.

In the above studies, if multi serotypes / genotypes / pathogenic types and other pathogens or pathogens of epidemic diseases that have not yet occurred in China are involved, if the required pathogen samples are difficult to obtain, bioinformatics methods can be used for analysis.

（7） Pilot production report and batch record

20. The pilot production of veterinary diagnostic products should be carried out in the applicant's corresponding GMP production line. The pilot production report shall be signed by the person in charge of production and the person in charge of quality

(1) Time, place and production process of pilot plant.

(2) Batch number (at least 3 consecutive batches), batch number and batch number of products.

(3) Product production and inspection report.

(4) Problems found in the process of pilot test and solutions.

21. Batch production and batch inspection records of at least 3 consecutive batches of pilot products.

（8） Clinical trial report

22. Details of clinical trials that have been conducted should be reported in detail, including all trial data that do not meet expectations. No less than 3 batches of products shall be used in clinical trials. The number of clinical samples for each target animal should not be less than 1000; for pet samples such as dogs and cats, the detection quantity should not be less than 500; for clinical samples of animal diseases that are difficult to obtain, the detection quantity should not be less than 50. At least 10% of clinical samples should be confirmed by other methods (preferably gold standard method). Clinical samples should include negative samples and positive samples (positive samples should not be less than 10%).

（9） The following registration requirements apply to innovative veterinary diagnostic products

23. The number of pilot production batches and the number of clinical trial samples should be doubled.

24. At least three veterinary laboratories (distributed in different provinces) shall conduct adaptability test (including sensitivity and specificity, and samples used shall include positive, weak positive, negative and other clinical samples or quality control samples), and issue evaluation reports (including intra batch and inter batch difference analysis).

3、 Import registration data items and their descriptions

（1） Import registration information items

1. General information.

(1) Supporting documents.

(2) Production outline, quality standard, and standard operation procedure of main finished product inspection items.

(3) Sample instructions and labels.

2. Research data of bacteria (virus, insect) species or other antigens for production.

3. Sources, quality standards and inspection reports of main raw and auxiliary materials.

4. Production process research data.

5. Preparation, inspection and calibration of quality control samples.

6. Product quality research data.

7. Batch production and inspection report, batch production and inspection record of at least 3 batches of products.

8. Clinical trial report.

（2） Description of import registration information

1. When applying for import registration, items 1-8 shall be submitted.

(1) The certification documents issued by the relevant administrative departments of the country (region) where the manufacturing enterprise is located for the approval of production and sales, and the certification documents issued by the relevant administrative departments of the country (region) where the production enterprise is located shall be notarized or certified, and then confirmed by the Chinese Embassy or consulate.

(2) If the representative office of a foreign enterprise in China handles Registration Affairs, a copy of the registration certificate of the Permanent Representative Office of a foreign enterprise in China shall be provided.

(3) If a Chinese agency is entrusted by an overseas enterprise to act as an agent for registration, the entrustment document and its notarized documents, and a copy of the business license of the Chinese agency shall be provided.

(4) The patent situation and ownership status of the product or prescription and process applied for, as well as the guarantee that the patent of others does not constitute infringement.

(5) Description of the registration of the product in other countries.

2. The test data used to apply for import registration shall be the test data obtained by the applicant outside China. Without approval, the test shall not be conducted in China for the purpose of import registration. During the registration process, the applicant may be required to submit the clinical verification test report conducted by the relevant units in China if it is considered necessary by the evaluation. The clinical validation test of in vivo diagnostic reagents should meet the requirements of "veterinary drug clinical trial quality management standard".

The Chinese and English translation of the application materials shall be consistent with the original Chinese and English versions.

4. In principle, other requirements of import registration and declaration materials are consistent with the corresponding requirements of domestic product registration and application materials.