MOA Announcement No. 1038 — 6 New Veterinary Drugs Including Cat Triple Vaccine and Pet Formulations (2026-07-06)
MOA Announcement No. 1038 (农业农村部公告第1038号) was issued by the Ministry of Agriculture and Rural Affairs of the People's Republic of China on 2026年7月6日 (July 6, 2026), promulgated pursuant to the *Regulations on the Administration of Veterinary Drugs* (《兽药管理条例》) and the *Measures for the Registration of Veterinary Drugs* (《兽药注册办法》).
The announcement approves 6 drug products as new veterinary drugs (新兽药), issues New Veterinary Drug Registration Certificates (《新兽药注册证书》), and publishes product quality standards, process specifications, package inserts, and labels, effective from the date of promulgation. It also covers 8 veterinary drug product registrations, 4 change registrations, and associated documentation.
> Source: Ministry of Agriculture and Rural Affairs, *Announcement No. 1038* (农业农村部公告第1038号), 2026-07-06.
Annex 1 — New Veterinary Drug Registration Catalogue (附件1 新兽药注册目录)
1. Chlorhexidine Acetate Solution (醋酸氯己定溶液) — pet topical drug (宠物用外用药)
| Field | Detail |
|---|---|
| Class (类别) | Category 3 (三类) |
| Registration certificate (新兽药注册证书号) | (2026)新兽药证字66号 |
| Monitoring period (监测期) | 3 years (3年) |
| Research units (研制单位) | 青岛农业大学、青岛康地恩动物药业有限公司、青岛诺安百特生物技术有限公司 et al. (10 units total) |
> Source text: 醋酸氯己定溶液 / 青岛农业大学... / 三类 / (2026)新兽药证字66号 / 3年 / /
Package insert excerpt (package insert, PDF pp. 1–2):
- Indications (适应症): 用于犬皮肤、创面及黏膜消毒 (For disinfection of dog skin, wounds and mucous membranes)
- Usage and dosage (用法用量): 外用:适量,喷于患处。一日2次,连用14日,或遵医嘱。 (External use: as appropriate, spray on the affected area. Twice daily for 14 consecutive days, or as directed by a veterinarian.)
- Adverse reactions (不良反应): 偶见过敏反应,如接触性皮炎等。 (Occasional allergic reactions such as contact dermatitis.)
- Specification (规格): 100ml∶1g
- Shelf life (有效期): 36 months (36个月)
- Storage (贮藏): 密闭,在凉暗处保存。 (Sealed, stored in a cool and dark place.)
2. Huangsang Qingfei San (黄桑清肺散) — veterinary use (兽用)
| Field | Detail |
|---|---|
| Class (类别) | Category 3 (三类) |
| Registration certificate (新兽药注册证书号) | (2026)新兽药证字67号 |
| Monitoring period (监测期) | 3 years (3年) |
> Source text: 黄桑清肺散 / 南京农业大学、山东益远药业有限公司... / 三类 / (2026)新兽药证字67号 / 3年 / /
3. Porcine Circovirus Type 2 Baculovirus-Vector Inactivated Vaccine (SL08 Strain) (猪圆环病毒2型杆状病毒载体灭活疫苗(SL08株))
| Field | Detail |
|---|---|
| Class (类别) | Category 3 (三类) |
| Registration certificate (新兽药注册证书号) | (2026)新兽药证字68号 |
| Monitoring period (监测期) | 3 years (3年) |
| Research unit (研制单位) | 齐鲁动物保健品有限公司 |
4. Newcastle Disease, Avian Influenza (H9 Subtype), Fowl Adenovirus (Group I Type 4), Infectious Bursal Disease Combined Inactivated Vaccine (鸡新城疫、禽流感(H9亚型)、禽腺病毒病(I群4型)、传染性法氏囊病四联灭活疫苗)
| Field | Detail |
|---|---|
| Class (类别) | Category 3 (三类) |
| Registration certificate (新兽药注册证书号) | (2026)新兽药证字69号 |
| Research unit (研制单位) | 青岛易邦生物工程有限公司 |
5. Feline Rhinotracheitis, Calicivirus, Panleukopenia Combined Inactivated Vaccine (WX+SH14+0918 Strains) (猫鼻气管炎、猫杯状病毒病、猫泛白细胞减少症三联灭活疫苗(WX株+SH14株+0918株)) — pet cat vaccine (宠物用猫疫苗)
| Field | Detail |
|---|---|
| Class (类别) | Category 3 (三类) |
| Registration certificate (新兽药注册证书号) | (2026)新兽药证字70号 |
| Monitoring period (监测期) | 3 years (3年) |
| Research units (研制单位) | 中国农业科学院上海兽医研究所、唐山怡安生物工程有限公司、哈药集团生物疫苗有限公司 |
Package insert excerpt (package insert, PDF pp. 5–8):
- Generic name (通用名称): 猫鼻气管炎、猫杯状病毒病、猫泛白细胞减少症三联灭活疫苗(WX株+SH14株+0918株)
- Per 1.0 ml (1 dose) vaccine contains (每1.0ml(含1头份)疫苗中含):
- Inactivated feline herpesvirus type 1, WX strain 10⁷·⁰ TCID₅₀ (灭活猫疱疹病毒1型 WX株 10⁷·⁰ TCID₅₀)
- Feline calicivirus, SH14 strain 10⁸·⁰ TCID₅₀ (猫杯状病毒 SH14株 10⁸·⁰ TCID₅₀)
- Feline parvovirus, 0918 strain 10⁴·⁰ TCID₅₀ (猫细小病毒 0918株 10⁴·⁰ TCID₅₀)
- Action and use (作用与用途): 用于预防猫鼻气管炎、猫杯状病毒病和猫泛白细胞减少症。免疫产生期为二免后10日,免疫期为12个月。 (Used to prevent feline rhinotracheitis, calicivirus disease and panleukopenia. Immunity develops 10 days after the second vaccination; immunity period is 12 months.)
- Usage and dosage (用法与用量): 皮下注射。8周龄以上健康猫首免,每只1.0ml(含1头份),21~28日后加强免疫1.0ml,以后每年加强免疫一次。 (Subcutaneous injection. First vaccination for healthy cats over 8 weeks of age, 1.0 ml (1 dose) each, booster 1.0 ml 21–28 days later, then once yearly.)
6. Gabapentin Oral Solution (加巴喷丁内服溶液) — pet use (宠物用)
| Field | Detail |
|---|---|
| Class (类别) | Category 4 (四类) |
| Registration certificate (新兽药注册证书号) | (2026)新兽药证字71号 |
| Monitoring period (监测期) | 3 years (3年) |
| Note (备注) | Subject to veterinary prescription-drug management (纳入兽用处方药管理) |
| Research units (研制单位) | 山东爱士津生物技术有限公司、烟台爱士津动物保健品有限公司、山东爱士津生物制药有限公司 |
Annex 2 — Veterinary Drug Change Registration Catalogue (附件2 兽药变更注册目录)
Selected notable changes (变更注册):
- 复方二氯苯醚菊酯吡丙醚滴剂 (Compound Diclorophenyl Ether Pyriproxyfen Drops): validity period changed from "24 months" (24个月) to "36 months" (36个月) (original standard source: MOA Announcement No. 917, 农业农村部公告第917号)
- 盐酸克林霉素内服溶液 (Clindamycin Hydrochloride Oral Solution): validity period changed from "36 months, 28 days after opening" (36个月,开启后有效期为28日) to "48 months, 28 days after opening" (48个月,开启后有效期为28日)
Annex 5 — Package Inserts and Labels (附件5 说明书和标签)
The attachment PDF includes full package inserts for:
- 醋酸氯己定溶液 (Chlorhexidine Acetate Solution) (pp. 1–4, pet topical drug / 宠物用外用药, for disinfection of dog skin/wounds/mucous membranes / 用于犬皮肤/创面/黏膜消毒)
- 加巴喷丁内服溶液 (Gabapentin Oral Solution) (pp. 9+, pet use / 宠物用, subject to veterinary prescription-drug management / 纳入兽用处方药管理)
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Source: pdf-raw/cn-approvals/ivdc-announcement-1038-attach-20260707.pdf (521 KB) + pdf-raw/cn-approvals/ivdc-announcement-1038-20260707.html · 农业农村部公告第1038号 (2026-07-06)