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Regulatory submissions in Latin America

Pharmaceutical dossier submissions in Latin AmericaLatin America is getting a lot of attention among pharmaceutical companies. Brazil and Mexico are already among the top ten ex-US markets. At the same time, diverse regulatory requirements across these markets create significant obstacles to efficient development and registration of new drugs. Some efforts are being made to harmonize submissions across the continent but complete harmonization is still a ways off.

Because of this lack of harmonization, it can be difficult to obtain information on the local requirements across Latin America. The following three presentations touch on different aspects of the drug submissions process and, together, provide a fairly complete picture:


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