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COFEPRIS Celebrates 20th Anniversary

By Miriam Bello | Tue, 07/06/2021 - 17:21

Mexico’s regulatory agency, the Federal Commission for the Protection against Sanitary Risks (COFEPRIS), celebrated its 20th anniversary highlighting its recent achievements, including the recent actions taken to eliminate approval delays, the update of the new molecules registry and the digitalization of dossiers.

COFEPRIS is a reference regulator in the Latin American region. During the recent celebration of the International Symposium "Health regulation in a post-COVID-19 world," to commemorate the 20th anniversary of COFEPRIS, the Minister of Health Jorge Alcocer said that the capacities of the regulatory agency strengthen those of other agencies in the region, while supporting the adoption of best practices and of sanitary surveillance systems. Of the 35 countries that make up the Americas, only eight have regulatory agencies qualified by PAHO as regional references.

During the event, Cristian Morales Furimann, Representative of PAHO in Mexico, highlighted COFEPRIS redesignation as a level IV regulatory authority in the Americas.

COFEPRIS was born as a federal agency and decentralized body of the government of Mexico, linked to the Department of Regulation and Sanitary Promotion of the Ministry of Health. On August last year, the commission lost its decentralized status and became part of the Deputy Ministry of Prevention and Health Promotion. As every other regulatory agency in the world, COFEPRIS has played an essential role in ensuring the safety of the products and services consumed in the country. COFEPRIS monitors the production, commercialization, import, export and marketing of medications, medical devices, pesticides, fertilizers, chemicals and makeup. The council regulates 44 percent of the food, beverages, tobacco, health care items and personal care items consumed in Mexican households. Overall, the products regulated by COFEPRIS represent about 10 percent of Mexico’s GDP. In addition, COFERIS regulates health and safety in workspaces and monitors risks derived from environmental factors.

COFEPRIS had a direct impact in the provision of healthcare services. Just during former President’s Enrique Peña Nieto’s administration, the commission approved 540 generic versions of previously patented medicines, which allowed the introduction of generic versions that could cost up to 70 percent less.

However, COFEPRIS approval process can still be improved. “When a new cancer drug is approved by the FDA, it takes COFEPRIS 56 months in average to approve it for use in Mexico,” said Cristobal Thompson, Executive Director of AMIIF, to MBN. “Canadians take two and a half years, while the average for the OECD is 18 months.”

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Miriam Bello Miriam Bello Journalist and Industry Analyst