New direction for health regulation in Mexico

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New direction for health regulation in Mexico

INICIO/Políticas y legislación | Posted 05/12/2025 0 Post your comment

Mexico's health regulator, Federal Commission for the Protection against Sanitary Risks (Comisión Federal para la Protección contra Riesgos Sanitarios, COFEPRIS, has embarked on a profound modernization to drastically cut approval times, aiming to become a globally recognized benchmark for efficiency and innovation.

On 29 May 2025, COFEPRIS announced that as part of the so-called ‘Plan México’, has initiated a profound transformation aimed at improving efficiency, reducing response times, and modernizing its regulatory processes.

Among the main achievements is a 65% reduction in the response time for clinical protocol applications, dropping from 115 to 40 days (with the goal of further reducing these times to a two-week response window in the future). Additionally, unnecessary procedures for over 2,200 medical devices have been eliminated as part of a risk-level-based simplification strategy.

The digitization and simplification of procedures, carried out in collaboration with the Agency for Digital Transformation and Telecommunications (ATDT), have been key to achieving these advancements. Simultaneously, COFEPRIS has signed strategic agreements with institutions such as the Mexican Institute of Industrial Property (IMPI), significantly reducing the time required to link patents and sanitary registrations from several months to just five days.

Furthermore, the partnership with the Coordinating Commission of National Health Institutes and High-Specialty Hospitals (CCINSHAE) has been strengthened to enhance the quality and scope of clinical research in the country.

As part of its commitment to transparency and regulatory excellence, regulatory criteria have been updated, and certifications for Good Manufacturing Practices have been aligned with international standards. All these efforts aim to achieve recognition for COFEPRIS as a World Health Organization (WHO) Listed Authority (WLA), a status granted by the WHO, which would facilitate the international recognition of registrations issued in Mexico.

This modernization process, driven by the current administration, seeks to consolidate a more accessible, effective, and population-centred health regulatory system. In an international context where regulatory agility is essential to facilitate access to new medicines and technologies, Argentina is also aligning with these global trends, promoting regulatory reforms to simplify and accelerate drug approval procedures [1].

The initiative launched by COFEPRIS not only represents a step forward for the Mexican healthcare system but also opens opportunities to attract investments and accelerate the availability of innovative treatments for patients.

Mexican guidelines for biocomparables

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Reference
1. GaBI Online - Generics and Biosimilars Initiative. Argentina streamlines drug approval process [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Dec 5]. Available from: www.gabionline.net/policies-legislation/argentina-streamlines-drug-approval-process

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