Federal Commission for the Protection against Sanitary Risk

Cofepris logo

Federal Commission for the Protection against Sanitary Risk (COFEPRIS) is a regulatory body in Mexico responsible for controlling and supervising the importation, exportation, manufacturing, advertising, and distribution of food, drugs, medical devices, and cosmetics in accordance with Mexican health regulations. It operates under the umbrella of the Mexican Ministry of Health. Its main goal is to protect the public health by ensuring the safety, efficacy, and quality of these products.

History

COFEPRIS was established as a decentralized organ of the Mexican government, with technical, administrative, and operational autonomy. Its creation was part of a broader effort to modernize and improve the regulatory oversight of health risks in Mexico, responding to the growing complexity of health issues related to consumer products and services.

Functions

The functions of COFEPRIS include, but are not limited to:

• Evaluating and approving new drugs and medical devices for their commercialization in Mexico.
• Monitoring the safety and efficacy of marketed health products through post-marketing surveillance.
• Regulating the advertising and promotion of health-related products to ensure truthful and non-misleading information is provided to consumers.
• Conducting inspections and audits of manufacturing facilities to ensure compliance with Good Manufacturing Practices (GMP).
• Issuing sanitary licenses for the operation of establishments involved in the production, storage, and distribution of health-related products.
• Overseeing the importation and exportation of regulated products to ensure they meet Mexican health standards.

Regulatory Framework

COFEPRIS operates under a comprehensive regulatory framework that includes the General Health Law (Ley General de Salud), which outlines the basic provisions for health regulation in Mexico, and various other specific regulations and official Mexican standards (NOMs) that detail the requirements for different types of products and services.

Challenges and Criticisms

Like many regulatory bodies worldwide, COFEPRIS faces challenges such as ensuring timely access to innovative treatments and addressing the illegal trade and counterfeit of health products. Criticisms have been directed at the commission for delays in the approval processes for new drugs and medical devices, which some argue can hinder access to important therapies.

International Cooperation

COFEPRIS has sought to strengthen its regulatory capacity through international cooperation, becoming a member of the International Medical Device Regulators Forum (IMDRF) and seeking alignment with guidelines from the World Health Organization (WHO) and the Pan American Health Organization (PAHO). It has also engaged in bilateral agreements with regulatory agencies in other countries to facilitate the exchange of information and best practices.

Impact

The work of COFEPRIS is crucial for public health in Mexico. By ensuring that health products meet safety and efficacy standards, COFEPRIS helps to prevent health risks associated with substandard or fraudulent products. Its role in regulating advertising and promotion also contributes to informed decision-making by consumers regarding their health.