Debate over drug safety priority variations in different countries
The conflicting priorities of getting new drugs to patients facing life-threatening diseases versus ensuring the safety of new medications are at the heart of a debate over a joint initiative between the Swiss non-profit organization Drugs for Neglected Diseases initiative and France-based drug major Sanofi-Aventis. The issue is over the urgency with which Sanofi has pushed for marketing approval for the antimalaria drug combination ASAQ (artesunate and amodiaquine; Marketletters passim).
Instead of pressing for approval of the drug in the biggest (and most regulated) markets of the USA and the European Union, the drugmaker has opted for fast-track clearance in Morocco, based on "relatively limited" clinical data, according to the Financial Times.
GSK applied in Mexico for Rotarix approval
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