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COFEPRIS has clarified its new abbreviated Reliance pathway, targeting a 45-business-day review for eligible medicines and creating a faster route for qualifying Medical Devices. For suitable products, CPC’s Fast-Track approach targets an overall registration process of approximately 10–15 months, depending on dossier readiness and pathway eligibility.
What’s New in the COFEPRIS Reliance Pathway?
The new pathway allows COFEPRIS to rely on assessments already completed by recognized Reference Regulatory Authorities (RRAs) and the WHO Prequalification Programme.
Recognized authorities include the FDA, EMA, Health Canada and Swissmedic. Applications must follow the CTD format, and the product submitted in Mexico must match the product approved by the selected authority.
Important requirements include:
- The foreign marketing authorization must remain valid.
- Accelerated, conditional and emergency approvals are not accepted.
- The reference authorization generally must not be older than five years.
For eligible medicines, COFEPRIS targets a 45-business-day review. The broader COFEPRIS Abbreviated Regulatory Pathway also covers Medical Devices. However in reality Marketing Approval can take years.
Why COFEPRIS Registration Can Still Take Years
Despite new digital and regulatory initiatives, Mexico continues to face legacy registration challenges. Approximately 10,000 applications submitted under the previous system remained pending, meaning that legacy registrations may still face significantly longer timelines despite the newer accelerated pathways. In CPC’s project experience, complex drug registrations can still take 4–5 years, especially when the wrong pathway is selected or dossiers require substantial corrections.
CPC Fast-Track Drug & Medical Device Registration
For suitable products, CPC’s Regulatory & Registration Service supports companies from pathway assessment and dossier GAP analysis through submission and COFEPRIS follow-up.
Figure 1. Fast Track Drug Registration Process in Mexico
Depending on product eligibility and dossier readiness, CPC targets an approximately 10–15 month Fast-Track registration process for drugs and Medical Devices in Mexico. Not every product qualifies for the same pathway. CPC therefore offers a free regulatory call to review your product, existing approvals and dossier status and identify the most suitable COFEPRIS registration strategy.
Mexico Pharma Market: Growth towards 2035
Mexico‘s pharma market boasts impressive growth rates, projected to reach USD 23,05 billion by 2035 at a 7,47% CAGR, making it the second largest in Latin America after Brazil. With a solid CAGR of 8,86%, the Mexican e-health market is projected to be valued at approximately USD 6,14 billion by 2035. For managers and industry leaders, this presents an exciting landscape ripe for exploration and investment.
Read Our Other Articles on Mexico
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- Mexico – Pharmacy Compounding Market Insights, Competitive Landscape & Regulatory Requirements
Chameleon Pharma Consulting Group (CPC) has over 20 years of experience in supporting Pharma, OTC, Medical Devices, Phyto, and Aesthetic Medicine companies. Having established own offices & local hubs across Latin America, Europe, Asia, the US/Canada, the Middle East, and the CEE/CIS regions is another advantage of CPC. With this local network and expertise gained from 300+ international projects and a team of 25 experts we offer our clients:
- Business Development, M&A, and Due Diligence
- Market Entry & Expansion: Systematic product and country analysis, market reports
- Strategic Partnering: Identifying local partners, acquisitions, or setting up own offices
- Regulatory & Registration: for drugs, MD, Derma, Aesthetic Medicine, etc.
- Market Authorization & Compliance: Holding MAs, conducting pharmacovigilance
- Quality & Certification: GMP certification, pre-GMP audits
Contact us today for your individual request at service@chameleon-pharma.com!
