International Standards and Mexico’s regulatory agency


Cristobal Thompson is the Executive Director at AMIIF (Asociacion Mexicana de Industrias de Investigacion Farmaceutica). The AMIIF represents more than 60 global companies with the aim of contributing to improving health in Mexico through innovative medicine. Here Cristobal discusses Mexico’s regulatory landscape and the countries advances in healthcare. 


Mexico has implemented important improvements that have favoured the judicial and regulatory certainty of regulated sectors.


Mexico is the fifteenth largest economy in the world. As the top exporting country in Latin America, it’s essential for Mexico to uphold international regulatory standards and adhere to the appropriate regulatory bodies to maintain its position as a global exporting power.


This applies to the industrial sectors regulated by the Federal Commission for Protection against Sanitary Risks (COFEPRIS), which make up 9.8% of Mexico’s GDP and 10.94% of its foreign trade. Among the regulated sectors, those that stand out are the food and beverage, pharmaceutical, chemical, medical devices, tobacco, and fertilizer and plant nutrient industries.


Since its creation in 2001, the Mexican regulatory authority has had the mission of preventing sanitary risks. It achieves this by implementing and strengthening processes, procedures, and standards while adopting international best practices for each regulated sector, resulting in benefits for Mexican citizens.  


Since the 67th World Health Assembly, which took place in May 2014, resolution AMS67.20 urges health agencies to adopt, through different models and mechanisms, best practices in governance, in particular, those related to transparency in decision-making. The resolution also asks for proactive participation in forums, working groups, and international collaboration networks that allow for the promotion of greater access to quality, safe, efficient, and affordable medical products. COFEPRIS, in following these recommendations, has received international recognition from the World Health Organization and the Pan American Health Organization, among other institutions.


Furthermore, based on legislative, regulatory, and normative changes, the health surveillance system in Mexico has implemented important improvements that have favoured the judicial and regulatory certainty of regulated sectors. The pharmaceutical industry has seen advances in the regulation of innovative, generic, biotech, and orphan drugs, as well as in the guidelines for the evaluation of new molecular entities, stability and good practices in manufacturing, labelling, and pharmacovigilance. Evidence of this can be found, among many other examples, in the possibility of making Mexico the launch country of a new drug through the implementation of clinical trials with the participation of Mexican patients.

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