各位大神, 有没有做过加拿大的原料药注册,想咨询下这个费用包括哪些。
加拿大官网(https://www.canada.ca/en/health- ... shment-licence.html)的法规信息太多了,看的我眼花缭乱,其中Funding and Fees ——Fees for human drugs板块,分别包括以下4大类:
human drug (pharmaceutical and biological) submission and application review fees (这个里面分类看不懂,每个价格好贵,都是一百多万)
master file fees (总的大概一万)
fees for examination of an application for an establishment licence
fees for the right to sell drugs
想问下,这四类费用分别用于什么情况?