COFEPRIS (Mexico) Publishes Guidelines for GMP Documentation for Active Ingredients, Medicines, and Medical Devices Submissions

On March 20, 2025, the Mexican Federal Commission for Protection against Health Risks (COFEPRIS) published in the Official Gazette (DOF) the Agreement Issuing the Guidelines for the Submission of Documents that Guarantee Good Manufacturing Practices (GMP) for Active Ingredients, Medicines, and Medical Devices. These guidelines apply to applications for new health registrations, as well as their extensions and modifications. The newly established regulations define the requirements and criteria for submitting GMP documentation, aiming to streamline compliance with international standards and enhance cooperation with recognized regulatory authorities.

关键亮点

• The guidelines specify the necessary documentation, including Certificates of Good Manufacturing Practices or equivalent documents, required for pharmaceutical ingredients, medicines, and medical devices in health registration applications, renewals, and modifications.
• Emphasis is placed on compliance with international GMP standards to ensure product safety, efficacy, and consistency throughout the manufacturing process.
• The affected product categories include:
  • Active pharmaceutical ingredients (APIs)
  • Over-the-counter (OTC) medicines
  • Prescription drugs
  • Various medical devices, including diagnostic and therapeutic equipment
• The regulation promotes alignment with globally recognized regulatory authorities, potentially facilitating easier access for compliant products in international markets.
• Manufacturers are encouraged to adhere strictly to these guidelines to maintain registration status and ensure a smoother approval process for new or modified health registrations.

下一步

• Manufacturers should assess and update their GMP documentation to align with the new COFEPRIS guidelines.
• Companies should ensure their production processes and quality control systems meet the revised regulatory expectations.
• Close monitoring of regulatory updates and proactive engagement with COFEPRIS will be essential to maintaining compliance and streamlining approval processes.