ajm73 I agree with your sentiment that some countries will not recognize it. They will definitely have some of their own specified regulations. For example, most regulatory agencies as I said before have de facto standards because it’s a basic requirement for all countries. I know that your sentiment is true because it’s happening already! Most agencies are playing catch-up to those with the strictest regulatory boundaries. Do I believe that, for example, the United Nations will create a global regulatory body? They could try but there’s no way to enforce it. Countries would have the ability to approve or not approve drugs/devices if they follow the global regulations or not! Judging by how nations have acted in the past, there either will be no global regulation or it will be in addition to country-specific regulations.