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.