The Globetrotting Regulator
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Keywords

Regulatory Convergence
Bioequivalence
Pharmacovigilance
Substandard Pharmceutical Events
Drug Regulation
FDA
EMA
API
Excipients
Cost Effectiveness
Outcomes

Abstract

I am putting in a lot of miles on behalf of international regulatory fraternity.

Like Johnny Cash said, “I’ve been everywhere†— or at least it seems that way. Recently I’ve visited with government health officials in China (both PRC and ROC), the Philippines, Malaysia, Egypt, Algeria, Saudi Arabia, Jordan, the United Arab Emirates, Kuwait, Russia, Brazil, Colombia, South Africa, Indonesia, Kenya, and many other points in-between. And the only thing that’s grown more than my frequent flyer miles is my respect and admiration for those over-worked and under-appreciated civil servants toiling on the front lines of medicines regulation. It’s a global fraternity of dedicated (and generally under-paid) healthcare and health policy professionals devoted to ensuring timely access to innovative medicines and quality generics drugs.  But, just as in similar Western agencies (USFDA, EMA, Health Canada, etc.), “doing the right thing†is often a battle of evolving regulatory science, tight resources, competing priorities … and politics.

https://doi.org/10.5912/jcb711
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