Drug regulation has failed to keep up with a globalized world and governments should harmonize oversight to improve patients’ access to new and innovative medicines.
That is the view of the former leader of the U.S. Food and Drug Administration (FDA), the world’s top drug regulator, and the research head of French drugmaker Sanofi, who made a joint plea to governments for action on Wednesday.
Margaret Hamburg, who led the FDA until 2015, and Elias Zerhouni said there was an urgent need to harmonize a “mosaic of regulations” in different countries, and they called for the issue to be taken up at the G8 or G20 groups of nations.
“We would challenge governments, including congresses and parliaments, presidents and prime ministers, to put harmonization on their agenda,” they wrote in an editorial in the journal Science Translational Medicine.
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