Regulatory Framework

Key Considerations for Cosmetic and Dietary Supplement Claims in Mexico

Key Considerations for Cosmetic and Dietary Supplement Claims in Mexico

Mexican regulations establish fundamental principles governing claims for cosmetic products and dietary supplements. The main objective is to ensure that these products are safe, effective, and not misleading to consumers.

Keys to the Labeling of Dietary Supplements in Mexico

     Keys to the Labeling of Dietary Supplements in Mexico

Dietary supplements are defined as products intended to increase or complement the total dietary intake, or to supply one or more of their components. COFEPRIS is the authority in Mexico responsible for regulating these products and for establishing the labeling requirements they must meet to be marketed in the country.

Classification Query: A Regulatory Tool for Marketing Your Cosmetics and Dietary Supplements

Classification Query: A Regulatory Tool for Marketing Your Cosmetics and Dietary Supplements

The classification query submitted to the Federal Commission for the Protection against Sanitary Risks (COFEPRIS) is a crucial step in regulating cosmetic products and dietary supplements.

Revolutionizing Health Product Access in Mexico: COFEPRIS Embraces Global Regulatory Reliance

Revolutionizing Health Product Access in Mexico: COFEPRIS Embraces Global Regulatory Reliance

COFEPRIS has published a new agreement recognizing the evaluations and approvals from key international regulatory authorities and the WHO Prequalification Program for sanitary registrations of medicines and medical devices. This move, effective 60 business days after publication, aims to expedite access to quality health inputs by adopting a "reliance" approach, simplifying import procedures for essential products during health crises.

Health Transformation: Key Incentives for Investment and Scientific Development in Mexico

Health Transformation: Key Incentives for Investment and Scientific Development in Mexico

This Decree, published in the Official Gazette of the Federation on June 2, 2025, establishes a regulatory framework aimed at promoting investment within Mexico to strengthen the pharmaceutical industry, the production of medicines, health inputs, and medical devices, as well as fostering scientific research. Its main objective is to reduce import dependency and ensure the availability of these essential products, using consolidated public procurement as a lever for economic development.

COFEPRIS: A Catalyst for Investment in Mexico

COFEPRIS: A Catalyst for Investment in Mexico

COFEPRIS is undergoing a significant transformation under "Plan México," aiming to become an agile, transparent, and internationally harmonized agency. This includes a push for 100% digitization of procedures, fostering clinical research, streamlining regulatory pathways, and modernizing the regulatory framework to boost investment and ensure public health.