Your comment seems to imply that said regulations are tougher than needed, and that if "FDA and European regulators" would loosen their standards, it would be a good thing.
That's my perspective. Regulators are heavily incentivized to prevent deaths, even small numbers, that will generate headlines and political pressure. There is no political voice for much larger numbers that would be aided by new drugs that come to market quicker in a looser regulatory scheme.
That said, I understand why the laws have been shaped the way they have.
Did I understand it correctly? Why is it so?