Rapid increase in the number of new molecular entities and biologics introduced as human therapies after the 1970s generated
great promise for patients around the world. During that period, drug development efforts were generally concentrated in three
major biopharmaceutical markets: the United States, Europe, and Japan. Even so, efforts at global harmonization of technical
requirements among the three major markets were not officially in place until 1990, when the International Conference on Harmonization
(ICH) was established. 1
PHOTOGRAPHY: GETTY IMAGES ILLUSTRATION: PAUL A. BELCI
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The ICH is a consortium comprising drug manufacturers and regulatory bodies in the three major drug development regions. The
establishment of ICH has enabled significant contributions to the existing drug development processes, specifically from a
regulatory perspective.
Over the past several years, biopharmaceutical companies have increased innovative research and development outside their
traditional boundaries with dramatic expansion of clinical drug development into many countries around the world. The reason
for this dramatic increase in globalization may be attributed to greater competition observed in the United States and European
markets and also to the current challenges with high costs, slow patient recruitment, and greater demand on qualified clinical
research professionals. Other reasons may include the rapid economic growth and improvement of regulatory processes in emerging
regions, partly driven by wider adoption of ICH guidelines and principles. Sponsors can find many opportunities to develop
their products in the nontraditional regions as part of their multinational strategy.
Lay of the land
Table 1. United Nations world population growth rate (2008 Prospectus).
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Like many parts of the developing world, Latin America continues to experience rapid population growth (see Table 1) and the rate is not expected to slow any time soon. A large population in this economically emerging region presents an opportunity
and many advantages for drug development. Some advantages include rapid growth of the pharmaceutical market; population concentration
in large urban centers such as Mexico City (Mexico), São Paulo and Rio de Janeiro (Brazil), and Buenos Aires (Argentina);
population heterogeneity; two official languages spoken in the entire region; and English language proficiency of most investigators
in the region.2Latin America is composed of all countries in the American continent where the languages derived from Latin (such as Spanish
and Portuguese) are primarily spoken. Spanning northern and southern hemispheres, the region has 21 countries with a total
population of over 550 million people, made up of demographically heterogeneous groups.3 After Africa and Asia, Latin America has the highest projected population growth of 11.1% by 2015.
Most Latin American countries are not actively producing new medical therapies and therefore are not directly involved in
the ICH decision making process. The ICH organization established a Global Cooperation Group (GCG) in 1999 and it has recently
invited non-ICH regional harmonization groups such as the Pan American Network on Drug Regulatory Harmonization (PANDRH) to
assign one permanent designee in the GCG. International harmonization in GCP is becoming a reality in the region's major markets.
This article reviews the current regulatory environment for the conduct of clinical research in Argentina, Brazil, and Mexico.
The article also highlights recent key regulatory changes and describes strategies to ensure successful and efficient conduct
of clinical trials in the region.
