The Mexican Federal Commission for the Protection of Sanitary Risks (COFEPRIS) has set specific goals to enforce a stricter national regulatory environment in Mexico.
IHS Global Insight perspective | |
Significance | The Mexican Federal Commission for the Protection of Sanitary Risks (COFEPRIS), the national health technology assessment agency, has set specific goals to enforce a stricter national regulatory environment in Mexico, especially on issues of pharmacovigilance, generics implementations, and regulating pharmaceutical and healthcare authorisations expedited in Mexico and the registration of Mexican products across Latin America. |
Implications | A more transparent regulatory environment and making further steps towards more harmonised regulations within Latin America will enable Mexico to strengthen regional commercial bonds with countries looking for partnerships with Mexico. |
Outlook | With the implementation of new regulations, COFEPRIS aims to enhance the safety and security of drugs approved in the country, as well as generating savings by boosting domestic generic production and its commercialisation. During the first six months of the year, COFEPRIS is looking to approve 15 branded and 20 generic new drugs, as well as harmonising registration with other Latin American countries. |
The Mexican Federal Commission for the Protection of Sanitary Risks (COFEPRIS) health technology assessment (HTA) agency has set specific goals to enforce a stricter national regulatory environment in the country, concentrating on issues of pharmacovigilance, generics implementations, and regulating pharmaceutical and healthcare authorisations expedited in Mexico and the registration of Mexican products across Latin America. COFEPRIS's Mickel Andoni Arriola Penalosa, cited by company sources, said the harmonisation of Mexican drug registration procedures with Chile and Peru may happen within the first half of 2013. According to the source, this will enable the country to export its products to Chile and Peru subject to an easier registration process, fostering the demand and production of Mexican products in these countries. Arriola said that the harmonisation of registration processes with Chile and Peru will be facilitated by the fact that regulations are already quite similar in these countries.
Mexico is also significantly moving towards a more transparent regulatory environment as a result of the recent certification of registration processes in the country by the Pan American Health Organization (PAHO) and the recent harmonisation of registry regulations with Ecuador and El Salvador. According to the source, Chile, Peru, Ecuador, and El Salvador have a potential total overall healthcare and pharmaceutical revenue of USD3 billion per year and a client base of more than 68 million potential patients. Arriola said the harmonisation of registry regulations with other countries will also help benefit the domestic pharmaceutical market as it will enhance production and exports in the region and internationally, as well as helping to launch the domestic pharmaceutical industry as an export market.
According to the first census of the Mexican pharmaceutical industry in 2009, drug exports accounted for USD738.10 million in 2009, and in the same year the country's imports accounted for USD475.50 million. Mexico's export to South America account for an average 47% per year of total exports; exports to Central America average 20%; 16% to North America; and 7% to the European Union. According to the source, between 2011 and 2012, COFEPRIS approved 14,000 sanitary registrations (modifications, renewals, new authorisations), accounting for a 5% increase of the national pharma market during that period.
Outlook and implications
A move towards a more transparent regulatory environment in Mexico and progressing further towards more harmonised regulations within Latin America will enable the country to strengthen regional commercial bonds with other countries looking for partnerships with Mexico, as well as boosting and expanding Mexico's pharmaceutical and healthcare production in the region. As a result of improved regulations and wider transparency, during the first six months of 2013, COFEPRIS is looking to approve 15 branded and 20 generic drugs on the market in the therapy areas of cancer, diabetes, central nervous system, and cardiovascular, which is expected to kick off the year with a great boost to the national pharmaceutical sector, providing an excellent opportunity for regional and international branded and generic companies wishing to register their drugs. Indeed, Mexico is flourishing with opportunities in the healthcare and pharmaceutical sector, and is the second largest pharma market in Latin America, after Brazil.
With the implementation of new regulation, COFEPRIS aims to increase the safety and security of drugs approved in the country, as well as generating savings for the the population by boosting domestic generic production and its commercialisation. The harmonisation of registration processes with other Latin American countries is part of a wider project Mexico is carrying out with the other top Latin American pharma markets, such as Brazil and Colombia, to smooth the regulatory process among countries in the region – in effect a regulatory free trade agreement – which will enable the country to register its products across Latin America more easily. For the first half of 2013, COFEPRIS is concentrating on Chile and Peru, subsequent to the recent harmonisation with Ecuador and El Salvador. By syncing up with these countries, Mexico will be able to expand its patient base and increase its already booming pharmaceutical sector, which is approaching a potential patient base of 15 million per year.