China veterinary drug comparative test requirements have been revised by the China Ministry of Agriculture (MOA) on May 13, 2024, to further encourage and guide veterinary drug manufacturers in conducting comparative tests. These new regulations will be effective from December 1, 2024, replacing previous requirements issued in 2016.
The updated requirements for veterinary drug comparative tests are based on the “Regulations on Veterinary Drug Administration” and the “Measures for the Administration of Veterinary Drug Product Approval Numbers.” These regulations aim to ensure that applications for veterinary drug product approval numbers include necessary comparative tests, such as bioequivalence tests and withdrawal period verification tests. Here is a summary of the key points from the updated requirements:
1. Requirements for Veterinary Drug Species Subject to Comparative Testing
- Scope of Comparative Tests: Comparative tests are mandatory for specific veterinary drug varieties listed in the directory issued by the Ministry of Agriculture and Rural Affairs.
- Reference Products: Reference products for comparative tests should ideally be the original veterinary drug products developed and produced by the original manufacturer. If these are no longer available, the China Institute of Veterinary Drug Control will select alternative qualified products available in the market, subject to approval by the Ministry of Agriculture and Rural Affairs.
- Test Samples: Test samples must meet the standards set by the veterinary drug manufacturing enterprise and should be taken from the GMP production line. These samples must pass quality checks conducted by provincial veterinary drug inspection agencies before being used in comparative tests.
- Dosage and Specifications: The dosage and specifications for comparative tests should match those of the reference products. Specific guidelines are provided for cases with multiple dosage specifications, single dosage specifications, and special cases involving different forms and uses of the drug.
2. Requirements for comparative testing activities
- Comparative Test Activities: Comparative tests must align with the approved indications for the reference product. For clinical efficacy validation tests, comparisons should be made with all approved indications of the reference product.. Individual indications that can’t be compared, manufacturers may apply for a waiver from the Livestock and Veterinary Bureau.
- Specific Test Requirements:
- Bioequivalence Tests: Veterinary drug preparations that can be tested for bioequivalence through blood concentration methods must prioritize bioequivalence testing in this manner. The bioequivalence test shall be conducted in accordance with the relevant guiding principles for bioequivalence test of veterinary chemicals and this Regulation.
- Clinical Efficacy Validation Tests: For drugs that cannot use the blood concentration method, clinical efficacy must be validated using models of artificially induced or naturally occurring diseases in animals.
- Withdrawal Period Verification: For drugs used in food-producing animals, the withdrawal period must be verified to ensure it matches or varies appropriately from the reference product. This does not apply to drugs used in pets.
3. Other related requirements
- Online Sampling Quantity: Test samples should be collected from the production line. The sample quantity must be sufficient for all necessary tests, including product quality inspection, bioequivalence, and withdrawal period verification.
- Approval of Comparative Test Product Numbers: For veterinary drug products that pass the comparative test review, an approval number will be issued. Approved labels, instructions, and target animals will be published on the “China Veterinary Drug Information Network” under the “National Veterinary Drug Basic Information Query System.” The approved enterprise standards will be stamped with the “Veterinary Drug Approval Special Seal” by the Ministry and kept by the veterinary drug manufacturing enterprise and the China Institute of Veterinary Drug Control. Regulatory authorities can access these records as needed.
- Comparative Test Labeling: For veterinary drug products that pass the comparative test review, manufacturers can print the words “Comparative Veterinary Drug” on the labels and instructions, using the same font as the generic name of the drug.
- Reissuance of Approval Numbers: When reissuing approval numbers based on the original comparative test requirements, there is no need to supplement additional comparative tests for other target animals.
Further information
Read the original announcement on China veterinary drug comparative test requirements – No.787.
Read our previous Veterinary Drug posts on Aquaculture drug efficacy trial guidelines – draft for comments.
GET IN TOUCH
