How To Choose Similar Products When The Safety And Effectiveness Evaluation Of The Product Under Application Involves The Comparison With Similar Products?

It is preferred to select products that have been approved for registration in China and that are basically equivalent to the product under application in terms of basic principle, structural composition, manufacturing materials, manufacturing process, performance requirements, safety evaluation, complied national/ industry standards, intended use, etc. If there is no such basically equivalent product, a product that is as similar as possible should be selected. If it is not possible to use marketed similar products for reasonable reasons, it is allowed to choose products that have been widely used clinically and have proven and recognized efficacy for the corresponding indications.