The Ministry of Agriculture and Rural Affairs issued a circular on the sampling inspection of the quality of veterinary drugs in the first phase in 2024
In order to strengthen the quality supervision of veterinary drugs and ensure the safe use of drugs, according to the 2023 National Veterinary Drug Quality Supervision and Sampling Plan, our department organized veterinary drug quality supervision and sampling inspections for veterinary drug production, operation and use units, and at the same time conducted follow-up inspections on relevant veterinary drug products found to have risks and hidden dangers in daily supervision. The relevant situation of supervision and sampling in the fourth quarter of 2023 is hereby notified as follows.
First, the overall situation
1 batch of ministerial supervision and sampling of veterinary biological products, and 1 batch of unqualified (see Annex 1); 2,802 batches of non-biological veterinary drug products were supervised and sampled at the provincial level, and 32 batches were unqualified (see Annex 2); 479 batches of non-biological veterinary drug products were tracked and inspected at the ministerial level, and 8 batches were unqualified (see Annex 3); 1 batch of fake veterinary drugs was found, and 2 batches of veterinary drug products that did not meet the regulatory requirements of veterinary drug traceability QR code (see Annex 4).
For information on qualified products for veterinary drug quality supervision and sampling, please log in to the "National Veterinary Drug Product Basic Data Query System" of the "China Veterinary Drug Information Network".
Second, the situation of unqualified products
(1) Unqualified sampling inspections at the ministerial level of veterinary biological products
One batch of African swine fever virus fluorescent PCR detection kits from one nominal manufacturer was inspected, and the results were unqualified. The unqualified items are sensitivity test and specificity test.
(2) Non-biological veterinary drug products are unqualified in provincial supervision and sampling
1. Overall situation: A total of 2,802 batches of products from 568 nominal manufacturers were inspected, and no illegal additives were detected. Among them, 32 batches of products produced by 32 enterprises were unqualified, and the product failure rate was 1.1%.
2. Unqualified items: mainly including traits, identification, inspection, content determination and other items. Among the 32 batches of unqualified products, 28 batches of products failed the inspection of 1 item, and 4 batches of products failed the inspection of 2 items.
3. Sampling links: The number of sampling inspections in production, operation and use links accounted for 11.7%, 79.7% and 8.6% of the total number of sampling inspections respectively, and the failure rates were 0, 1.3% and 1.2% respectively.
4. Product categories: chemicals, antibiotics, traditional Chinese medicines, and other products accounted for 38.0%, 37.9%, 22.1%, and 2.0% of the total number of samples, and the failure rates were 1.0%, 1.0%, 1.3%, and 3.6% respectively.
(3) Non-biological veterinary drug products are unqualified in the ministry-level follow-up inspection
1. Overall situation: A total of 479 batches of products from 108 veterinary drug manufacturers were tracked and inspected, of which 8 batches of products produced by 6 enterprises were unqualified, and the product failure rate was 1.7%. None of the products were detected with illegal additives.
2. Unqualified items: 1 batch of product traits and content determination failed, 1 batch of product inspection failed, and 6 batches of product content determination failed.
3. Product categories: chemicals, antibiotics, traditional Chinese medicine, and other products accounted for 33.2%, 45.3%, 20.5%, and 1.0% of the total number of samples, and the failure rates were 0, 2.8%, 2.0%, and 0.
(4) Fake veterinary drugs and veterinary drug products that do not meet the regulatory requirements of veterinary drug traceability QR code, and 1 batch of fake veterinary drugs was found. 2 batches of veterinary drug products for which traceability information could not be queried.
Third, focus on monitoring the situation of enterprises
According to the principle of determining key monitoring enterprises in the "2023 Veterinary Drug Quality Supervision and Sampling and Risk Monitoring Plan", it is proposed to identify the following enterprises as key monitoring enterprises:
(1) Yongji Yellow River Fish Disease Prevention and Control Center. The content of the current veterinary drug quality notification product is less than 50%.
(B) Yongji Yudaifu Aquatic Preparation Factory. The content of the current veterinary drug quality notification product is less than 50%.
(3) Wuhan Wusi Dongbao Pharmaceutical Co., Ltd. The content of veterinary drug quality notified products is less than 80% throughout the year, and a total of 2 batches have been accumulated.
(4) Sichuan Hongsheng Technology Co., Ltd. The content of veterinary drug quality notification products is higher than 120% throughout the year, with a total of 2 batches.
(5) Gansu Tianlida Biotechnology Co., Ltd. The content of the current veterinary drug quality notification product is less than 50%.
Fourth, the relevant work requirements
For fake and inferior veterinary drugs found in random inspections, all localities should organize and do a good job of investigation and handling in a timely manner in accordance with the requirements of the "Measures for the Management of Veterinary Drug Quality Supervision, Random Inspection and Inspection" and the "2023 Veterinary Drug Quality Supervision and Sampling and Risk Monitoring Plan"; Track and trace the origin of fake and inferior veterinary drug products, and increase the supervision and inspection of nominal production enterprises, and strictly investigate and punish illegal acts in accordance with the law. If the unqualified products are operated and used and confirmed by the production enterprise, the competent department of animal husbandry and veterinary medicine where the production enterprise is located shall promptly file a case for investigation and punishment of the production enterprise; If the veterinary drug manufacturer is not confirmed, the provincial animal husbandry and veterinary department shall conduct investigation and verification; If it meets the circumstances of heavier punishment for serious violations of veterinary drugs, its veterinary drug production and business license shall be revoked in accordance with the law.
After the completion of the investigation and handling of the case, the provincial animal husbandry and veterinary department shall promptly report the relevant law enforcement and case handling to the Animal Husbandry and Veterinary Bureau and the Department of Laws and Regulations, and organize relevant units to disclose the case investigation and handling information in accordance with the law; For those who meet the conditions for revoking the approval number of veterinary drug products, the proposal to revoke the approval number of veterinary drug products should be reported to the Animal Husbandry and Veterinary Bureau of our Ministry in a timely manner.
Contact person and telephone: Wang Zidong, Animal Husbandry and Veterinary Bureau, Ministry of Agriculture and Rural Affairs, 010-59193267
Annex:
1. Summary table of unqualified products under ministerial supervision and sampling of veterinary biological products in the fourth quarter of 2023
2. Summary table of unqualified non-biological products veterinary drug products under provincial supervision and sampling in the fourth quarter of 2023
3. Summary table of unqualified non-biological products veterinary drug products for ministerial follow-up inspection in the fourth quarter of 2023
4. Summary table of fake veterinary drugs and veterinary drug products that do not meet the regulatory requirements of veterinary drug traceability QR code found in the fourth quarter of 2023
General Office of the Ministry of Agriculture and Rural Affairs
January 30, 2024
Annex 1
Veterinary Biologics Q4 2023
Summary table of unqualified products under ministerial supervision and sampling
Annex 2
Provincial supervision and sampling in the fourth quarter of 2023
Summary table of unqualified non-biological veterinary drug products
Note: If the samples taken from the veterinary drug business and use links are judged to be unqualified after inspection, the sampling conclusion only represents that the batch of veterinary drug products sold or used by the sampled unit has quality problems, and usually cannot directly prove that the same batch of veterinary drug products produced by the nominal veterinary drug manufacturer or the same batch of veterinary drug products sold by other veterinary drug business enterprises also have quality problems.
Annex 3
Ministerial follow-up inspection in the fourth quarter of 2023
Summary table of unqualified non-biological veterinary drug products
Annex 4
In the fourth quarter of 2023, the fake veterinary drugs found in the surveillance sampling inspection and
Summary table of veterinary drug products that do not meet the regulatory requirements of veterinary drug traceability QR code
Source: Ministry of Agriculture and Rural Affairs