Navigating Emerging Markets — Latin America - Latin America's diverse growing market seeks regulatory harmonization. - BioPharm International

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Navigating Emerging Markets — Latin America
Latin America's diverse growing market seeks regulatory harmonization.

BioPharm International
Volume 26, Issue 4, pp. 60-63

KEY REGULATORY CONSIDERATIONS

The primary regulatory consideration across the Latin American region for pharmaceutical companies is the increasing trend toward standardized regulations. Each of the seven major markets has adopted regulations that are based on Mercosur or PAHO's recommendations. For example, Brazil revised its GMP standards in 2010 to ensure greater consistency with Mercosur/PAHO recommendations. Updates to Brazil's GMPs addressed the areas of quality, sanitation, hygiene, qualification and validation, contracts, and computer system validation. Since then, Brazil has been moving ahead with implementation, including the release of a guidebook for inspections in May 2012.

In other cases, such as Mexico, international agreements like the North American Free Trade Agreement protect foreign companies interested in expanding their business into the region. The Mexican federal commission for sanitary risk (COFEPRIS) also holds equivalence agreements with Health Canada and FDA for the regulation of drugs and medical devices. Additionally, in September 2012, COFEPRIS and the Chilean Public Health Institute signed a cooperation agreement that will allow for the harmonization of regulatory requirements within the Americas region, breaking the entry barrier present in many countries. The agreement, which is still at the "memorandum of understanding" (MOU) stage, is a bilateral mechanism that is eventually expected to allow the mutual recognition of marketing authorizations, inspection visits, and GMP certification. Mexico has also signed other equivalence MOUs with El Salvador and Ecuador, and a MOU is in the making with Colombia. MOUs with Brazil and Argentina are expected in the near future.

Even with all of these agreements, there is no Latin American equivalent of the European Medicines Agency—no common body with the power to facilitate greater consistency across countries. Mercosur and PAHO can make recommendations, but cannot enforce a common set of rules the way a common governing body can. And to complicate matters, even as countries implement regulations to be more aligned with Mercosur and PAHO recommendations, they may not implement the same regulations at the same time.

Despite the many efforts carried out by the major Latin American markets, the road toward total harmonization is steep. The main reasons are the size of the region and the number of countries included in the area, each of them with their own regulatory system, political background, and policy approach to healthcare and pharmaceuticals. One proposal has been that of convergence rather than harmonization similar to what is in use in the Asia Pacific Economic Cooperation Area (APEC). Regulatory convergence is a voluntary process in which the countries in question agree to work toward regulatory requirements that are similar, but not fully harmonized. Harmonization would require changing laws in each country and is, therefore, more difficult to achieve. Convergence of regulations is considered as the most viable solution for the Latin American region.


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