Mexico's COFEPRIS to ease internal regulatory barriers, boost production standards for domestic drugs

Mexico's Federal Commission for the protection Against Sanitary Risks (COFEPRIS) has set out new standards to ease internal regulatory barriers to allow the entry of drugs in the country and implemented the harmonisation of production standards for domestic drugs. According to COFEPRIS's federal commissioner, Mikel Arriola, cited by Milenio, "COFEPRIS is looking to eliminate entry barriers for drugs entering the Mexican market and achieving international harmonisation of production". The source states that further to an internal reorganisation of the system that has involved the simplification of bureaucratic barriers and the outsourcing of some services, the agency has managed to speed up internal operations and achieve governmental certification that will allow COFEPRIS to also be involved in managing business and investment opportunities for pharmaceutical companies operating in the country, acting as a sort of business promoter for the national pharmaceutical sector.

Furthermore, COFEPRIS in the last 12 months was designated as the regional reference agency for the Americas by the Pan America Health Organization. The term "reference agency" refers to the fact that any registration, approval, or certification granted by COFEPRIS in Mexico will be considered valid by other Latin American states adhering to this new designation. This process also works in terms of the approval of drugs produced in Mexico in other Latin American countries that adhere to the programme, as it will allow a Mexican laboratory to approve the drugs or use a certificate they own in Mexico in other Latin American countries without the need for any additional certification. As a result of this regional harmonisation, from 2013 Costa Rica, Ecuador, and El Salvador are now also recognizing COFEPRIS's certificates. Following the recent treaty with El Salvador, Mexico is now exporting generic drugs there, saving El Salvador's government up to 90% of the costs it was spending on meeting the drug needs for its public healthcare sector (see Mexico: 31 May 2013: Mexico to export generic drugs to El Salvador). Furthermore, Mexico is already part of a free drugs interchange treaty with countries such as Colombia, Chile, and Peru.

Outlook and implications

COFEPRIS's new regulations intended to ease regulatory barriers for the entry of drugs and its harmonisation with international standards are significant of a new overall reorganisation of the system, aimed at easing regulatory processes to increase international pharmaceutical operations in the country and promote the export of Mexican products abroad.

The structural changes implemented by COFEPRIS in its regulatory system and the efforts of harmonising the internal production of drugs to international standards are expected to influence the export of domestic drug products, which is expected to increase. This increase in production for external purposes is expected to help the Mexican government save on the pharmaceutical budget, as it will save on costly imports and strengthen the position of domestic firms operating in the country. In the past seven years, Mexico has increased its drug imports by 90%, while exports have increased by only 30% (source: Milenio), and it is expected that the new regulation could overturn this system. By investing in the development of domestic firms, the government will be able to strengthen the country's pharmaceutical market, which has established itself as the second largest pharmaceutical market in the Americas – preceded only by Brazil – and placed it among the 11 top pharmaceutical markets in the world.