Understanding Regulatory Compliance in Mexico: A Comparative Overview

The federal regulatory group in Mexico is known as the COFEPRIS (Comision Para La Protececcion Contra Riesges Sanitaries) or Federal Commission for the Protection against Sanitary Risk. It was founded on 7/5/2001 and is headquartered in Mexico City.

Like the FDA, COFEPRIS covers pharmaceuticals, food, and many other domains as detailed below.  The drug approval process parallels the NDA track of FDA with 3 phases with similar responsibilities.  A successful completion of the 3 phases originally took 1 to 4 years. There have been revisions in the requirements to accelerate the time to final approval.

COFEPRIS enforces Good Manufacturing Practices (GMP) with facilities inspections. Facilities with GMP certifications from referenced external countries (USA, Canada, Brazil, Australia, Japan, EU, etc.) are exempt from these inspections.

COFEPRIS differs from FDA by providing direct, as opposed to third party, certification services.  Certifications must be renewed every 5 years.

COFEPRIS requires pharmaceutical production documentation according to GMP as defined in NOM-164.

These requirements include:

·      Quality Management Systems

·      Quality Risk Management

·      Facilities and equipment

·      Qualification and validation

·      Production systems

·      Quality Control Laboratories

·      Product Withdrawal from the Market

·      Subcontracted Activities

·      Destruction and final destination of waste

·      Manufacturing of drugs for use in clinical studies

Generally, these guidelines are stringent standards intended to ensure the safety, efficacy, and quality of drug products, requiring consistent quality control based on those guidelines.

Other Regulated Domains:

Dietary Supplements

Producers of dietary supplements in Mexico must comply with the following:

·      Regulation on additives and coajuvants (Ingredients included to increase the effectiveness of other ingredients)

·      Regulation on allowed and prohibited plants for teas, infusions, and edible oils

·      The Mexican Herbal Pharmacopeia

·      NOM 248 the standard for Dietary Supplements

·      NOM 251 for Good Hygiene Practices in manufacture

Cannabis

Cannabis products are presently divided by percentage of TCH content, presently >1.0% THC. CBD is defined as a nonpsychoactive cannabis product below the threshold.

Many specifics for both examples are pending as of this writing.

https://mexiconewsdaily.com/mexico-living/puff-puff-pass-the-cloudy-legality-of-cannabis-in-mexico/

Please refer to COFEPRIS updates for the latest information.

E-liquids

Cartridges containing nicotine are illegal; e-cigarettes are generally prohibited with some exceptions at the retail level.

Conclusion- COFEPRIS has built a regulatory platform for Mexico that utilizes several important aspects of control like other comprehensive world codes and parallels many of them. The agency seeks to complete coverage on several types of products but is presently most definitive in the pharmaceutical and dietary supplement domains.

References (Articles and regulations as included in text)

·      Generis Corporation, “An Overview of Pharmaceutical Regulations in Mexico: Approval Processes, Manufacturing Standards, and Compliance Penalties” 11/23/24

·      COFEPRIS  https://www.gob.mx/cofepris

·      Miguel Angel Torres Tello  @ Veraque Consulting, Mexico City

Miguel.torrestello@veraqueconsulting.com

·      Insumo Para La Salud  (international regulatory consulting firm)

www.insumoparasalud.com

·      CMS International Law Firm, Mexico City, Writings by Mauricio Gomez Guerrero, Partner, and Manual Ferrara, Associate  www.cms.law

·      Wikipedia