Regional Reports

Drug Regulation in Mexico: Five Principles, Visible Progress and a Long Way Ahead

Jaime Oliveira
Global Forum
Central/South America Regional Editor


exico is the second largest economy in Latin America and the country’s medicines market ranks among the world’s twenty most important. Mexico’s national drug regulatory authority, COFEPRIS, is one of the best equipped agencies in Latin America, and was classified in 2012 as a national regulatory authority of regional reference by the Pan-American Health Organization.

In March 2016, COFEPRIS launched the “5 principles and 15 actions for protection against health risks” program, which established the regulatory authority’s priority areas of attention. The five principles, to which the fifteen actions are linked, encompass the areas of ethics, expertise, efficiency, competitiveness, and institutional global approach. The ethics principle involves transparency and access to information by the Mexican population to increase confidence in the agency. The expertise principle targets improvements in the regulatory environment for clinical trials and strengthening pharmacovigilance activities in the country. The efficiency principle refers to collaboration with other national authorities for economic and private sector development aiming at streamlining the Mexican population’s access to health technologies (including innovative drugs and generics), strengthening products oversight activities, and prevention of health risks through basic sanitation. Through the competitiveness principle, COFEPRIS intends to promote simplifying administrative pathways, deregulation based on risk stratification, facilitate exports, and give regulatory support and advice to high-impact economic sectors such as the food, pharmaceutical, and chemical industries. The global approach principle refers to COFEPRIS’ engagement with international counterparts and regulatory boards and the consolidation of its status as reference national regulatory authority in the Americas.

COFEPRIS has taken important steps, especially in the regulatory field, towards these aims. To streamline drug registration, the agency has invested in the consolidation of a unique strategy of regulatory reliance based on previous decisions by internationally recognized authorities (the “Equivalence Agreements”) and on previous review of dossiers by certified local third parties. The New Molecules Committee, the commonly alleged bottleneck of those processes, was reformed in 2017; positive outcomes of this institutional reform are expected for 2018. As for regulatory convergence and harmonization, COFEPRIS has recently become a member of the Pharmaceutical Inspection Co-operation Scheme and is actively engaged in the harmonization and trade facilitation negotiations of the Pacific Alliance bloc.

COFEPRIS is also pursuing regional leadership in regulatory excellence and good regulatory practices with the launch of COFEPRIS’s Center of Regulatory Excellence earlier this year. In addition, efforts have been made to raise the country’s clinical trial performance, such as the agreement signed by COFEPRIS, The National Institute of Cancerology, and local pharmaceutical industry associations CANIFARMA, AMIIF, and ANAFAM, which will allow for expedited clinical trial protocol review and approval.

Although there is no unanimous perception of concrete results on streamlined drug registration, regulatory harmonization, and a friendlier clinical trial environment, COFEPRIS’ clear agenda and permanent dialogue with industry have already resulted in substantial improvements in the regulatory environment in Mexico and will certainly bring more gains to patients, industry, and the agency itself in the medium- and long-term.

Expectations now focus on Mexico’s 2018 federal elections and COFEPRIS’ possible application to become a member of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use. These will define the direction of COFEPRIS in the years ahead.