Ah, I see you have looked at the space but never followed a drug all the way. It's crony capitalism everywhere, the governments pick winners, and the difference is whether you get to book the bribe as a legitimate business expense or not, and whether you bribe the regulatory body in the form of a service fee, or follow the Olympic Organizing Committee model and just pay to send the decisionmaker's kids to college.
The regulatory bodies over most of the world accept each others' study results. The EU countries are obvious, but Sweden, non-EU former-Soviet states, and the rest of the planet (the ones that have regulatory agencies) all accept a double-blind standard.
It's the FDA that mandates tests that deviate from the standard everybody follows. So the tests need to be re-done. And CFR 18 Rule 21 compliance issues are also incompatible with the EU electronic signature for research records directive, meaning double-entry is forced there as well.