Office of Generic Drugs, Pharmaceuticals and Medical Devices Agency, 3-3-2, Kasumigaseki, Chiyoda-ku, Tokyo, 100-0013, Japan.
Bureau of Pharmaceutical Sciences, Therapeutic Products Directorate, Health Canada, Ottawa, Ontario, Canada.
Drugs R D. 2017 Sep;17(3):371-379. doi: 10.1007/s40268-017-0186-8.
Generic drugs are assuming an increasingly important role in sustaining modern healthcare systems, as the cost of healthcare, including drug usage, is gradually expanding around the world. To date, published articles comparing generic drug reviews between different countries are scarce.
The objective of this study was to examine generic drug reviews in Japan and Canada.
We surveyed generic drug reviews from Japan and Canada and compared the following points: general matter (application types, type of partial change or Supplement to an Abbreviated New Drug Submission, application and approval numbers, review period, application format, review report, responsibility for review), bioequivalence studies for solid oral dosage forms, and bioequivalence guidelines, guidance, or basic principles regarding various dosage forms.
This survey described the many similarities and differences in generic drug reviews between the two countries and points that should be improved to promote better generic drug reviews. In particular, regulations for the definition of the same or different active pharmaceutical ingredients (APIs) are similar for both authorities.
The results clarified the future challenges of generic drug reviews, and the differences highlighted by this survey will be important considerations for the future. This is the first article to present and discuss the details of generic drug reviews between Japan and Canada.
随着医疗保健成本（包括药物使用）在全球范围内逐渐扩大，仿制药在维持现代医疗保健系统方面发挥着越来越重要的作用。迄今为止，发表的比较不同国家仿制药审查的文章很少。
本研究旨在考察日本和加拿大的仿制药审查。
我们调查了来自日本和加拿大的仿制药审查，并比较了以下几点：一般事项（申请类型、部分变更或简略新药申请补充的类型、申请和批准编号、审查期、申请格式、审查报告、审查责任）、固体口服剂型的生物等效性研究，以及各种剂型的生物等效性指南、指导原则或基本原则。
本调查描述了两国仿制药审查的许多相似之处和不同之处，以及为促进更好的仿制药审查而需要改进的方面。特别是，两个当局对相同或不同活性药物成分（API）的定义的规定相似。
研究结果阐明了仿制药审查的未来挑战，本调查强调的差异将是未来的重要考虑因素。这是第一篇介绍和讨论日本和加拿大之间仿制药审查细节的文章。
