1) No, not even theoretically. Since "prove" means different things to different organizations.

2) I didn't say there are no additional requirements. For example, you have to fill out some paperwork. I said they are trivial compared to actually making a drug that works and proving that it works. Drugs do not die because of the approval processes, they die because it's unfathomably hard to make drugs that work and then to prove that they work.