Clinical Trials in Latin America Get a Boost from Improved Regulatory Compliance Processes


With its large and diverse population, Latin America continues to be an important region for clinical trials. However, despite the benefits of a large treatment naïve population, complex regulatory frameworks and lengthy approval times present a unique set of regional challenges when setting up new clinical studies.  A group of countries in Latin America is working hard to address these issues.

The governments of several Latin American countries have realized the importance of making their countries more competitive for clinical trials so they have begun simplifying clinical trial requirements or simply improving the approval process.

Brazil, for example, issued new clinical trial regulations in March of 2015 that made the country more responsive in processing clinical trial applications. Brazil’s RDC Resolution 09/2015[i] shortened the time required for application approvals by defining a fixed timeframe (90 to 180 days) within which the Ministry of Health (ANVISA) must respond to clinical trial applications.

In an August of 2015 press release,[ii] Mexico’s Ministry of health, COFEPRIS, declared ‘Mexico the Most Competitive Latin American Country in Clinical Protocols for New Medicines.’  COFEPRIS based this assertion on the fact that it had approved another research hospital to be a third-party reviewer (Ethics Committee Approver) of clinical protocols in Mexico; bringing the total number of approved third-party reviewers in the country to 14. With these 14 institutions approving protocols COFEPRIS proclaimed that that protocol approval times had reduced by 66%.

On March 21, 2016, Argentina’s ANMAT announced its commitment to finding ways to make the country more competitive for clinical trials by proactively looking for ways to update and improve the clinical trial approval process while still ensuring patient safety and pharmacovigilance.[iii]

As Latin American countries continue to innovate and improve clinical trial competitiveness in the region, we expect clinical trial participation to increase and for Latin America to become a region of choice for sponsor companies. This is a win for pharmaceutical companies but especially a win for patients.




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