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We are planning to use a comparator for a global Phase 2 study for a small molecule drug. The comparator is approved in all countries we intend to use it in and the generic is approved in many of the countries as well. We are trying to source it from a single source and it is looking like the best option is to source it from Germany so the label, packaging (it's in a blister pack) and package insert is all in german. We plan on overlabeling with the appropriate language per region. Does the package insert need to be translated as well? We would like to leave the packaging in tact so we don't have to "repackage". The regions we will be going into are: US, Canada, UK, Romania, New Zealand, Australia, China, Taiwan, Hong Kong and South Korea. Does anyone have experience with this and know what the requirements are in any of these regions? Also, what documents or information is required for regulatory submissions? Any help would be much appreciated.