E-DRUG: Outsourcing of Medicine Regulation work?
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Greetings from Rizwan!
In a recent country mission in Africa, I met a young lady who asked me if
I knew of countries which have outsourced their medicine regulation work to
third party. My response to this great question was that I don't know but
that this issue came up a couple of decades ago in the U.S. when the
Republican-controlled Congress called for an overhaul of the Food and Drug
Administration. The principal complaint was that the FDA was too slow in
approving drugs compared to its European counterparts and the Agency was
labelled a "Foot Dragging Agency".
My question to my E-drug colleagues is if they could please share any
examples where drug regulation work has been outsourced to private
entities/organizations until the formal establishment of a national
regulatory agency?
Best wishes,
Rizwan
Syed Rizwanuddin Ahmad, MD, MPH, FISPE, FCP
Consultant with a Special Interest to Strengthen National
Medicines Regulatory Systems
Ex-Consultant/Safety Reviewer (1998-2013), U.S. Food and Drug Administration
Assistant Professor (adjunct)
Georgetown University School of Medicine, Washington, DC, USA
www.drugsafetyconsultant.com
Syed Ahmad <drugsafetyconsultant@gmail.com>