The Federal Commission for the Protection against Health Risks (COFEPRIS) is responsible for ensuring the health and safety of Mexico’s citizens. COFEPRIS has gone through significant transformation and modernization, eliminating in the past few years a backlog of around 8,000 market authorizations. The actions implemented included a risk-based re-organization of procedures, implementation of specialized lanes, on-line registration preview, adoption of authorized third parties and vaccines’ risk-based lot release. As a result of those actions, COFEPRIS has become a reference of Good Regulatory Practices in Mexico and the Latin America region.
The Federal Commission for the Protection against Health Risks (COFEPRIS) is responsible for ensuring the health and safety of Mexico’s citizens through regulation and surveillance of food, healthcare products and services. COFEPRIS regulates nearly 10 percent of the Mexican Gross Domestic Product; therefore, its policies and procedures have the potential to affect not only the public health of our citizens, but also a sizeable segment of our national economy.
Mexican pharmaceutical policy is based on four pillars: a regulatory agency that guarantees the safety, quality and efficacy of medicines; a reliable and predictable market authorization procedure; the removal of barriers to market entry for safe, efficacious and high quality products; and the harmonization with best international regulatory practices. These pillars are aligned with the government´s health priority of increasing population access to quality health products and services.
Since its beginning in March 2011, COFEPRIS has gone through a significant transformation and modernization, eliminating the past few years’ backlog of around 8,000 market authorizations, issuing pending regulatory updates and implementing a comprehensive administrative simplification program, international harmonization and reinforced sanitary surveillance.
The actions implemented included a risk-based reorganization of procedures, implementation of specialized lanes, on-line registration preview, authorization of third parties, and vaccines risk-based lot release.
The specialized lanes for medicines and medical devices filings led to a significant reduction in time of response. Processing time of simple administrative changes went from one year to a maximum of 15 days. Previously, all procedures had to be reviewed on a first-come, first-served basis, independent of their complexity.
The authorized third parties approach has also significantly reduced processing time. For example, processing time for market authorizations of new drugs was reduced by approximately two years on average.
In terms of removing barriers, COFEPRIS has promoted the market entry of new generic medicines and a policy facilitating the access to innovative medicines. As a consequence, in the past four years, 32 active substances have been released, corresponding to 357 market authorizations of new generic medications which resulted in an average reduction of 61 percent in drugs prices.
COFEPRIS has also negotiated equivalence agreements for new drugs with the medicine agencies of U.S., Canada, Australia, Switzerland and European Union. These agreements allow a fast-track authorization process, avoiding duplication of efforts and facilitating access. During the past four years, 150 new innovative drugs entered into Mexico, and four medicines utilized Mexico as a platform for global launch.1 In 2010, only two innovative medicines entered the Mexican market.
To stimulate clinical trials, a collaborative partnership was negotiated between the U.S.’s National Institutes of Health and the Mexican Institute of Social Security for their pre-statement of protocols, reducing authorization time from three months to one month, a 66 percent reduction in time.
On the international front, COFEPRIS was recognized by the Panamerican Health Organization in 2012 and by the World Health Organization in 2014, becoming part of selective group of certified agencies.
The pharmaceutical policy implemented by COFEPRIS has reduced out-of-pocket spending in Mexico. Between 2009 and 2013, it has decreased from 49.6 percent to 44.1 percent of total health expenditures, a decrease of 5.5 percentage points in five years.
COFEPRIS has become a standard of good regulatory practices in Mexico and Latin America. In November 2015, COFEPRIS hosted the International Conference of Medicines Regulatory Agencies, a result of COFEPRIS’s presence in the international regulatory agenda.
