I've just returned from Singapore where I spent some quality time with Raymond Chua (the director of the Singapore HSA -- their version of the FDA) and his senior staff. We covered a wide variety of issues ranging from "what's new at the USFDA?" (Answer -- a lot!), global regulatory convergence, and much in between (such as Singapore as a regulatory “third way” in addition to the FDA and EMA).
The HSA directorate was particularly interested to discuss the USFDA's expedited review pathways (breakthrough therapy designation, accelerated approval, priority review, etc.) and some of the ways they’re impacting regulatory policy (i.e., adaptive clinical trial design, senior staff commitment, earlier sponsor/agency interaction). Per Raymond, the HSA is "pathway agnostic" -- an interesting concept that deserves more discussion and consideration in White Oak. He was also keen to learn more about the USFDA's new "Super Office" of Pharmaceutical Quality. (For more on this, see here.)
When it comes to 21st century drug and device regulation, Singapore is a place to study for best practices as well as innovation in both cogitation and action.
The Merlion roars loudly and proudly on behalf of it’s nation’s public health. And there's much the rest of the world can learn from both it's practices and world view.
(And the eats are pretty spectacular too. I recommend the Chili Crab.)
