| 本文已被：浏览 897次 下载 748次 |
码上扫一扫！ |
| 兽药注册技术要求国际协调会成员国家或地区自家疫苗的监管控制 |
| 刘博,马欣,杜吉革,辛凌翔,魏津,刘燕,罗玉峰,姚文生,张存帅 |
|
|
| (中国兽医药品监察所) |
|
| 摘要: |
| 传染病对畜牧业生产构成巨大威胁,自用疫苗的合理使用可以帮助控制和预防畜/禽群中的传染病,从而保障动物健康,护航养殖发展。伴随对于加强自用疫苗注册监管呼声日益增强,本文从总体情况、法规指南、批准类型、评审材料要求、使用限制等几个方面,对VICH成员国家关于自用疫苗的监管控制进行梳理,为构建我国兽用自用疫苗的审批监管制度提供参考。 |
| 关键词: 自用疫苗，兽药注册技术要求国际协调会，法规指南 |
| DOI： |
| 投稿时间：2023-09-26修订日期：2023-11-06 |
| 基金项目: |
|
| Regulatory Control of Autogenous Vaccines in the VICH regions |
|
| (China Institute of Veterinary Drug Control) |
| Abstract: |
| The spread of infectious diseases in farms poses a threat to livestock production, and the rational use of autogenous vaccines can help control and prevent infectious diseases in livestock/poultry flocks, thus safeguarding animal health and improving production performance. Accompanied by the increasing calls for strengthening the registration and regulation of autogenous vaccines, this review summarized the regulatory control on autogenous vaccines in VICH regions from the aspects of background, regulatory guidelines, types of approvals, and requirements of dossiers, to provide a reference for the development of the evaluation and approval machanism of veterinary autogenous vaccines in China. |
| Key words: Autogenous vaccine VICH Regulatory guidelines. |
