加拿大 兽药API注册审评期限
注册申报

请问各位: 加拿大注册兽药API ,付费完成后 多久可以得到审批结果?

2026-01-14 14:05 李家云     
1个回答

跟你付费的时间没关系。

目前没有查到关于多久可以批准的直接描述,比较值得参考一下的官网原文是说,加拿大卫生部MF管理处将在收到完整材料包后30个日历日内处理(process)所有MF交易相关信息及材料(该日期视为MF行政程序完成日)。强烈建议MF持有人至少在申请人提交药品申请、DIN申请或CTA提前2个月完成MF或新LoA的注册。这里不确定“处理process”是否可以直接理解为批准。

希望对你有帮助。

https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/master-files-procedures-administrative-requirements/implementing-processing-assessing-updating.html

Master File Performance Standards

Health Canada's MF Administration Unit will process all information and material filed with an MF transaction within 30 calendar days of receiving a complete package (the date the MF is considered administratively complete). MF holders are strongly encouraged to register MFs or new LoAs at least 2 months ahead of an applicant's drug submission, DIN application or CTA.

2026-01-16 13:36 白bai