Announcement No. 2464 of the Ministry ε÷≥¥of Agriculture of the People's Republic of China

In order to effectively do a goδ'♥od job in the supervision and inspection of non©≥ -clinical research and ≈Ω♣ clinical trials of veterinary drugs, acc÷↔✘ording to the Regulations on the Administ↓$'↕ration of Veterinary Drugs and the Quality Manag★§ement Standards for Non-clinic↔δ✔al Research of Veterinary Drugs&α↓₹, the Quality Management Standards for Clinica★↕±☆l Trials of Veterinary Drugs, and ↔∏the Measures for the Supervision a♣↔↕®nd Inspection of the quality Management St ∞>→andards for Non-clini∑φ®'cal Research and clinical Trials of Veterina₹δ&≈ry Drugs, The Ministry has organized and forδ↑↑εmulated the Supervision and Inspe ∞✘∏ction Standards for the Quality Managemen ‌t of Non-Clinical Studi÷®es of Veterinary Drugs, the Suε¶pervision and Inspectioπ₽≠n Standards for the Quality Management of Veteβεrinary Drugs Clinical Trials and α¥™​the related requirements for super$₹vision and inspection (see annex),♦™<✘ which are hereby issued and shall c​‍★ome into force as of the ∏≈ date of promulgatio> ££n. The relevant announcem​ ≠♠ents are as follows.&&>✘

1. Units that have carried o™≠ut safety evaluation of veterinary drugs fo♠ ♠r the first time, and units that ‌‍≈εhave carried out safety evaluation of ≤>veterinary drugs but §αhave not yet accepted theλ₽←↔ supervision and inspection of t✘™he quality management standards of non-c‌£≥•linical research of veterinary drug¶₽s or the quality management standards of ♣♣♦•clinical trials of veterinary d≠♣♥rugs of our Ministry, shall submit reports and←♣ relevant materials to the China Veter®¥∞≥inary Drug Supervision a•←∞÷nd Inspection, and accept s€≥εΩupervision and inspection.

(2) All safety evaluation tests for non-clinical★φ studies of veterinary drugs sha‍ελll be undertaken by veterinary drug safety evalππuation units that are not affiliated wit★•₽h or have other interests in the development of ✘∑♥new veterinary drugs.

3. Comparison tests involving α™♠clinical validation, bio <₽equivalence and drug withdrawal periodβ§↕★ verification involving the£><π approval number of veterinary drug produφ嶙cts shall be undertaken by veterinary drug sσ₩afety evaluation units (inc≈♥luding comparison test institutions) thatσ↑ are not affiliated with or have oε₩"↔ther interest in the applβ>ication enterprise for the app ♠roval number of veterinary drug products.

4. Without the supervision and inspe♠‌•♦ction of the Ministry or the λ← supervision and inspection of vete↓β•rinary drug safety evalβ≥'<uation units (including compar¶∏™₽ison test institutions), the completed res↔•‌£earch and test data shall not be used for veteriλ✔nary drug product approval number appli ∞♥cation.

5. The research and test data completed by t←₹he veterinary drug safety evaluation unit before   ≠₩December 31, 2017, and the evaluation re£ ™port has been issued, can continue to✘↑★☆ be used for veterina αry drug registration application. ‍© Since January 1, 2018, the co>∞✔mpleted research and test data of veterinary drugγ₽★↑ safety evaluation units that hav✘↕±✘e not been supervised and inspected "δ‌★by our Ministry or havδ♦£↕e failed to pass the supervision and<♠₩ inspection shall not≠σ be used for veterinary drug r→§egistration application.

Vi. The veterinary drug safety evaluation ÷£unit shall carry out relevant​∑φ work in strict accordance with th€"e relevant provisions of the Regulatio↕™♦→ns on the Administrat±→≥‌ion of Veterinary Drugs and the Quality Manag♣' ement Standards for Non-clinical Rese←π•arch of Veterinary Drugs, the Quality Manage₩↕πment Standards for Veterinary Dr↑≥α"ugs Clinical Trials,≤™  and the Supervision and®←‌↓ Inspection Measures for the quality management÷< standards for non-clinical r→✘λesearch and clinical trials of Veterinary׶ Drugs, and effectively stan$σ←☆dardize research activities.

It is hereby announced φ♦×.

Annex: 1. Standard for supervision and inspection×≈  of quality management practices in non-clinic÷$al studies of veterinary d™÷&↑rugs

2. Requirements for supervisio'¥σ≈n and inspection of quality management standa≈↕rds for non-clinical studies of ve®φ↑terinary drugs

3. Veterinary drug clinical trial quality man↑×¥agement standards for supe∏&rvision and inspection (chemical drugs, Chine©>≠se medicine)

4. Veterinary drug clinical trial quality ma★★'nagement standards supervision and inspection s®≠tandards (veterinary biological produ♦≥cts)

5. Requirements for supervision and in≠∏γspection of quality managem£ ∏®ent standards for veterinary drug clinical¥♦© trials

6. Supervision and insp ↕ection of veterinary dr☆∑ug non-clinical researc±¶Ω"h and clinical trial qualit ₩≠y management standards

Ministry of Agriculture

October 27, 2016