COFEPRIS Simplifies Authorization of Clinical Trials in Mexico – Opportunity for International Investment

Published in the Official Gazette on March 24, 2025, the Resolution establishes a Trusted Regulatory Practices (Reliance) framework allowing COFEPRIS to recognize Phase III clinical trial approvals granted by agencies such as the FDA, EMA, MHRA, or Health Canada. This development streamlines evaluations, prevents duplication, and enhances international cooperation, creating a more agile, predictable, and investment-friendly regulatory environment for global pharmaceutical and biotechnology companies.

At Pérez-Llorca, our Life Sciences and Healthcare team is ready to support clients navigating this new regulatory landscape.

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