Latin America advances regulatory harmonization through greater ICH engagement

Latin America is making steady progress in harmonizing its regulatory frameworks and strengthening participation in international regulatory processes, gaining recognition and support along the way.

In recent years, countries across the region have advanced in adopting the guidelines of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH). These guidelines serve as a compass, guiding regulatory authorities toward higher standards of safety, quality, and innovation.

Agencies such as Argentina’s ANMAT, Mexico’s COFEPRIS, and Brazil’s ANVISA are now full members of the ICH. By incorporating international standards, they are improving the quality, safety, and efficacy of medicines in their respective markets. According to experts from the Latin American Federation of the Pharmaceutical Industry (FIFARMA), the organization has supported these efforts by helping stakeholders understand and implement global best practices.