| Rapid changes in medicines regulations in Mexico have had a drastic impact upon the country’s pharmaceutical industry, writes Christopher Davies at Pharmalink Consulting
The Mexican pharmaceutical market is the leading Latin American market and the tenth largest worldwide (1). The population of Mexico as of 2004 was 107,029,000 (2). It has seen continued growth over recent years as the result of a strengthening economy and increased trade with countries included in the North American Free Trade Agreement (NAFTA), as well as the EU. There have also been attempts by the government over the years to expand healthcare coverage to a greater percentage of the population.
Mexican health regulations are very complex. All pharmaceutical products that are sold in Mexico have to obtain sanitary registrations (authorisations to market a medicinal product) for which only the manufacturer of the pharmaceutical product is eligible to apply.
The Secretariat of Health has overall responsibility for overseeing the quality, safety and efficacy of drugs and medical equipment, as well as ensuring that manufacturing facilities operate to the standards of good manufacturing practice (GMP). It maintains national registries for all health supplies, regulates marketing by issuing licenses and health product registrations (sanitary registrations) and, in addition, oversees all advertising. The verification, analytical control and evaluation of drugs and supplies is performed by Secretariat of Health laboratories or authorised third-party institutes.
REGULATORY AUTHORITY
Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS) is the regulatory authority in Mexico and is a decentralised department of the Secretariat of Health. It has technical, administrative and operational responsibility for the protection of the population against health risks through publichealth regulation, control and promotion. |
