COFEPRIS is undergoing a significant transformation under "Plan México," aiming to become an agile, transparent, and internationally harmonized regulatory authority. This includes a comprehensive push for 100% digitization of procedures, fostering clinical research, streamlining regulatory pathways, and modernizing the regulatory framework. These efforts are designed to boost investment, enhance efficiency, and ensure public health.
UPDATE
The Federal Commission for the Protection against Sanitary Risks (COFEPRIS) is strategically aligning its operations with "Plan México," aiming to undergo a fundamental transformation into an agile, transparent, and internationally harmonized regulatory authority. This comprehensive overhaul is designed to act as a significant driver for investment in Mexico. A key initiative is the ambitious goal to achieve 100% simplification and digitalization of all procedures, with substantial progress already made in reducing processing times and requirements. Uocoming digitalization efforts will focus on import permits, various notifications, and all foreign trade-related procedures under the scope of "Plan México".
COFEPRIS is also heavily focused on promoting clinical research within Mexico, having already reduced review times for clinical research protocols from 115 days to 40 days, with an ultimate target of shortening this timeline to one to two weeks. As part of this effort, the agency is publishing agreements for recognizing equivalences with international agencies, reducing requirements for multicenter clinical studies, and digitalizing regulatory processes for protocols and amendments through the Digipris platform. Mexico stands out as a strategic location for clinical research due to its existing infrastructure, high-quality researchers, diverse population, and favorable epidemiological profile.
Furthermore, COFEPRIS is modifying regulatory pathways by shifting from lengthy permit processes to more agile notification-based mechanisms. A notable example is the deregulation of medical devices through risk reclassification, which will streamline or even eliminate sanitary registration requirements for over 2,200 medical devices. In parallel, the agency is implementing a new scheme to provide specific technical guidance to industry from the inception of new projects, particularly for companies investing in Mexico. This ensures projects meet required sanitary standards from the outset.
The modernization of Mexico´s regulatory framework is an ongoing process, with recent updates including agreements on protocols and good manufacturing practices guidelines. Forthcoming updates will address equivalency agreements for new drug and medical device registrations, the health supplies regulation (including innovative therapies), and various other norms and guidelines. Additionally, COFEPRIS has also forged a strategic collaboration with the Mexican Institute of Industrial Property (IMPI) to accelerate the linkage between drug patents and sanitary registrations, successfully reducing inter-agency consultation times from months to less than one week.
Finally, COFEPRIS is actively pursuing international recognition and is currently in a transitional phase toward becoming a fully recognized regulatory authority by the World Health Organization (WHO). The ultimate objective is to attain the highest level of recognition, ensuring that registrations granted in Mexico are recognized and accepted internationally. The overall objective of these initiatives is to establish a more robust, agile, human-centric, and efficient regulatory system that better serves the health needs of the Mexican population.
REGULATORY FRAMEWORK
These updates are closely aligned with and impact the broader Mexican regulatory framework for health products, particularly the regulations related to sanitary licenses, Good Manufacturing Practices (GMP), clinical research protocols, and the classification and registration of medical devices. Furthermore, the collaboration with IMPI involves the intersection between health regulation and intellectual property rights, particularly in pharmaceutical products. The pursuit of WHO recognition indicates Mexico´s commitment to align with international health regulatory standards and practices.
Effects from RA Update
The proactive measures undertaken by COFEPRIS are expected to have several positive impacts on business operations within the health sector. The simplification and digitalization of procedures will significantly reduce administrative burdens, shorten time-to-market for products, and lower operational costs for companies. The emphasis on fostering clinical research positions Mexico as a more attractive destination for pharmaceutical and medical device development, potentially encouraging greater investment and innovation. The deregulation of certain medical devices will directly reduce regulatory hurdles for manufacturers and distributors. Additionally, the new technical guidance scheme will provide greater predictability and clarity for new investment projects, minimizing risks and ensuring compliance from early stages. Lastly, the ongoing modernization of the normative framework and international recognition efforts will strengthen regulatory certainty and facilitate global market access for products registered in Mexico.
Written By:
Josué Garza
About ips
Our expert regulatory affairs team at IPS is uniquely positioned to guide medical device manufacturers through the evolving Mexican regulatory landscape. With a profound understanding of COFEPRIS's strategic initiatives and a proven track record of success, we can help your company navigate the simplified procedures and ensure compliance with the modernized regulatory framework.
Contact your service leader or email us at info@insumosparasalud.com to optimize your regulatory strategy and accelerate your market access in Mexico.