Overview
On December 16, 2025, COFEPRIS published the Draft Mexican Official Standard PROY-NOM-177-SSA1-2025, a major update to the regulatory framework governing bioequivalence, comparative bioavailability, BCS-based biowaivers, and comparative dissolution studies. The draft, currently under public consultation, will replace NOM-177-SSA1-2013 and further align Mexico with FDA and EMA standards.
Introduction
What’s Changing?
The new draft shifts the focus from interchangeable medicines to a more precise regulation of bioequivalence and biowaivers. Notable updates include:
- Clearer scope centered on bioequivalence, bioavailability, BCS-based biowaivers, and dissolution profiles, with biotechnological products treated separately.
- Updated legal basis under the Quality Infrastructure Law, including use of the national digital platform for public consultation.
- Stronger BCS framework, enabling greater use of biowaivers and reducing the need for in vivo studies for eligible products.
- Higher requirements for Authorized Third Parties, particularly in quality management systems, data integrity, and IT validation.
- Enhanced statistical oversight, aligning bioequivalence assessment with current international guidance.
Why It Matters
PROY-NOM-177-SSA1-2025 offers potential cost and time savings through expanded biowaiver opportunities, while also requiring greater investment in quality and data integrity systems. Early preparation will be key to ensuring a smooth transition and avoiding regulatory delays.
At Global Regulatory Partners, we are actively supporting clients in assessing impacts, participating in public consultation, and preparing for compliance with the new NOM.
Conclusion
The publication of PROY-NOM-177-SSA1-2025 represents one of the most significant regulatory updates in Mexico’s pharmaceutical landscape in recent years. By strengthening the framework for bioequivalence, bioavailability, BCS-based biowaivers, and dissolution studies, COFEPRIS is moving toward greater alignment with international standards while increasing expectations for scientific rigor, data integrity, and quality systems.
For pharmaceutical companies, this draft standard brings both opportunities and challenges: expanded biowaiver pathways may reduce development timelines and costs, but compliance will require early planning, robust documentation, and readiness to meet stricter requirements for third-party laboratories and authorized entities.
As the regulation remains under public consultation, now is the ideal time for companies to assess potential impacts, adapt their regulatory strategies, and ensure a smooth transition once the final standard is implemented.
At Global Regulatory Partners, we remain committed to helping clients navigate these changes, participate in the consultation process, and maintain full regulatory compliance in the evolving Mexican market.
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References
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- This article is based on the Draft Mexican Official Standard PROY-NOM-177-SSA1-2025 published by COFEPRIS in December 2025.
About Global Regulatory Partners
Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices, pharmaceutical, cosmetic and Food Supplement companies globally.
GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and South Korea. GRP helps many life science companies register their products in different countries in compliance with local regulations.