| 摘要: |
| 宠物用抗肿瘤药正在成为研发热点,美国FDA于2009年发布了伴侣动物用抗肿瘤药指导原则,EMA发布了犬猫用抗肿瘤药指导原则并于2022年1月28日开始实施。本文采用EMA的框架维度对两个指导原则安全性和有效性评价的关键技术要点进行分析,为研发者提供参考。 |
| 关键词: 兽药 抗肿瘤药 犬猫用 指导原则 |
| DOI： |
| 投稿时间：2022-04-06修订日期：2022-04-26 |
| 基金项目:中国兽医药品监察所“兽药行业公益性终点专项”编号：GY202106 |
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| Overview of FDA/EMA Guideline on Dossier Requirements for Anticancer Medicinal Products for Dogs and Cats |
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| (China Institute of Veterinary Drug Control) |
| Abstract: |
| Anti-cancer drugs are becoming a hot spot in research and development of veterinary drug using in pets. The guideline of oncology drugs for companion animals was issued by U.S. Food and Drug Administration in 2009. The other document related to anti-cancer veterinary drug,guideline-dossier-requirements-anticancer-medicinal-products-dogs-cats-revision-1,was released by European Medicine Agency and implemented on January 28, 2022.This paper uses the framework of EMA guideline to analyze the key technical points of the safety and efficacy evaluation of the two guiding principles. It can be provided reference for new veterinary drug sponsors. |
| Key words: veterinary medicinal product anti-cancer drug for cats and dogs guideline |
