As an emerging market, Mexico has become a key country for business development and industrialization with great potential for growth in the pharmaceutical industry as more individuals join the middle class. Regulatory agencies like COFEPRIS have opened up the doors of the national pharma market to international companies by providing a friendly regulatory environment that speeds up access to the public.
The Federal Commission for the Protection of Sanitary Risks in Mexico, COFEPRIS, has signed an equivalency agreement with national regulatory agencies from Australia, United States, Canada, European Union and Switzerland known as "Agreement for the Promotion of Innovation". Through this arrangement, COFEPRIS recognizes and validates the sanitary registrations issued in these countries and works jointly with other agencies to evaluate new products before authorization is granted. Before this agreement, COFEPRIS had to repeat in Mexico the clinical analyses for drug approval performed by each regulatory agency abroad, which delayed the introduction of new medicines to the national pharmaceutical market. With the new regulations, the waiting time has decreased by about 82%, cutting that time to about 60 days.*
Additionally, COFEPRIS issued a reform to promote clinical research in Mexico on October 2012. Under this new regulation, companies that want to commercialize a drug in the country must provide a certificate of clinical trials done on the Mexican population, which increases drug efficacy and preference among the population by ensuring the long-term effects of the product. This measure creates an opportunity for international pharma companies to develop drugs in one of the most promising emerging markets while cutting opportunity cost from nearly $45 to $40 million USD and the regulatory burden in about 82%.*
Mexico's regulatory environment is changing to accommodate the necessities and interests of international pharmaceutical companies eager to expand their market reach to Latin America. Mexico's health regulatory agency, COFEPRIS, was recognized by the Pan American Health Association (PAHO) and granted the highest level in good health practices and quality inspection in July 2012. Since then, Mexico has become an access door to countries like Ecuador and El Salvador, who accept sanitary registrations issued by COFEPRIS and grant permissions in approximately 45 days. *
Join us in Biopharma Mexico this October and understand first-hand how the regulatory environment in Mexico's pharma industry is constructing a welcoming atmosphere for international companies by decreasing the approval time for drugs.
*COFERPIS: Increasing Access to Medicines: Regulatory Approval Systems in Emerging Markets