Announcement No. 2464 of the Ministry of Agriculture of the People's Republic of China

In order to effectively do a good job in the supervision and inspection of non-clinical research and clinical trials of veterinary drugs, according to the Regulations on the Administration of Veterinary Drugs and the Quality Management Standards for Non-clinical Research of Veterinary Drugs, the Quality Management Standards for Clinical Trials of Veterinary Drugs, and the Measures for the Supervision and Inspection of the quality Management Standards for Non-clinical Research and clinical Trials of Veterinary Drugs, The Ministry has organized and formulated the Supervision and Inspection Standards for the Quality Management of Non-Clinical Studies of Veterinary Drugs, the Supervision and Inspection Standards for the Quality Management of Veterinary Drugs Clinical Trials and the related requirements for supervision and inspection (see annex), which are hereby issued and shall come into force as of the date of promulgation. The relevant announcements are as follows.

1. Units that have carried out safety evaluation of veterinary drugs for the first time, and units that have carried out safety evaluation of veterinary drugs but have not yet accepted the supervision and inspection of the quality management standards of non-clinical research of veterinary drugs or the quality management standards of clinical trials of veterinary drugs of our Ministry, shall submit reports and relevant materials to the China Veterinary Drug Supervision and Inspection, and accept supervision and inspection.

(2) All safety evaluation tests for non-clinical studies of veterinary drugs shall be undertaken by veterinary drug safety evaluation units that are not affiliated with or have other interests in the development of new veterinary drugs.

3. Comparison tests involving clinical validation, bioequivalence and drug withdrawal period verification involving the approval number of veterinary drug products shall be undertaken by veterinary drug safety evaluation units (including comparison test institutions) that are not affiliated with or have other interest in the application enterprise for the approval number of veterinary drug products.

4. Without the supervision and inspection of the Ministry or the supervision and inspection of veterinary drug safety evaluation units (including comparison test institutions), the completed research and test data shall not be used for veterinary drug product approval number application.

5. The research and test data completed by the veterinary drug safety evaluation unit before December 31, 2017, and the evaluation report has been issued, can continue to be used for veterinary drug registration application. Since January 1, 2018, the completed research and test data of veterinary drug safety evaluation units that have not been supervised and inspected by our Ministry or have failed to pass the supervision and inspection shall not be used for veterinary drug registration application.

Vi. The veterinary drug safety evaluation unit shall carry out relevant work in strict accordance with the relevant provisions of the Regulations on the Administration of Veterinary Drugs and the Quality Management Standards for Non-clinical Research of Veterinary Drugs, the Quality Management Standards for Veterinary Drugs Clinical Trials, and the Supervision and Inspection Measures for the quality management standards for non-clinical research and clinical trials of Veterinary Drugs, and effectively standardize research activities.

It is hereby announced.

Annex: 1. Standard for supervision and inspection of quality management practices in non-clinical studies of veterinary drugs

2. Requirements for supervision and inspection of quality management standards for non-clinical studies of veterinary drugs

3. Veterinary drug clinical trial quality management standards for supervision and inspection (chemical drugs, Chinese medicine)

4. Veterinary drug clinical trial quality management standards supervision and inspection standards (veterinary biological products)

5. Requirements for supervision and inspection of quality management standards for veterinary drug clinical trials

6. Supervision and inspection of veterinary drug non-clinical research and clinical trial quality management standards

Ministry of Agriculture

October 27, 2016