Mexico fast-tracks Korean drug approvals

MFDS-approved medicines eligible for simplified review and accelerated approval in Mexico

Recognized as the 8th reference regulatory authority under the WHO WLA framework…expected to boost pharmaceutical exports

Pharmaceuticals that have received marketing authorization from Korea’s Ministry of Food and Drug Safety (MFDS) will now benefit from simplified review and approval procedures in Mexico.

Approvals may be granted in as little as 45 business days, following Mexico’s decision to officially recognize the MFDS as a Reference Regulatory Authority (RRA) for pharmaceuticals.

Accelerated approval and review processes in Mexico are expected to create a more favorable environment for the export of domestic pharmaceuticals.

On June 23, the MFDS announced that Mexico’s Federal Commission for the Protection against Sanitary Risks (COFEPRIS) has formally recognized the Korean regulator as an RRA in the pharmaceutical sector.

As a result, medicines already approved in Korea can now apply for marketing authorization in Mexico through the Abbreviated Regulatory Pathway (ARP) based on Korea’s RRA recognition. This pathway is expected to simplify technical reviews related to quality, safety, and efficacy while significantly shortening approval timelines.

Mexican regulators currently operate an expedited approval system that relies on regulatory decisions made by agencies that are either founding or standing members of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), or are included on the World Health Organization’s WHO-Listed Authority (WLA) list.

Last year, the MFDS achieved full WLA designation across all functions for pharmaceuticals and vaccines, reinforcing its international regulatory credibility.

Under the abbreviated pathway, products approved by the MFDS may receive a regulatory decision in Mexico within 45 business days. COFEPRIS allows for the use of assessment results given by the reference authority and focuses primarily on verifying the completeness of submitted documentation, without requiring additional technical reviews or further data.

Mexico also recognizes Good Manufacturing Practice (GMP) certificates issued by regulatory authorities listed under the WHO WLA framework that possess inspection capabilities; consequently, local firms can utilize their MFDS-issued GMP certificates for market access.

Mexico is considered the second-largest pharmaceutical market in Latin America after Brazil. The MFDS expects the recognition to support the expansion of Korean pharmaceutical exports into Latin America and enhance the global competitiveness of domestic drugmakers. The Korean pharmaceutical industry likewise views the measure as a potential gateway for broader expansion throughout the Latin American region.

MFDS Minister Yu-Kyoung Oh said, “Mexico’s recognition of the MFDS as a reference regulatory authority is a meaningful achievement that once again confirms the excellence and international credibility of Korea’s regulatory system. We will continue to expand global regulatory cooperation so that high-quality Korean medical products can enter overseas markets more quickly.”

Yun-hong Noh, Chairman of the Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA), stated, “Korean pharmaceutical companies have long faced challenges in the Mexican approval process, and this measure is expected to enable much faster approvals. We hope this serves as a catalyst for broader market expansion in Mexico and throughout Latin America.”

Mexico is the eighth country to recognize the MFDS as a reference regulatory authority, following the Philippines, Paraguay, Egypt, Ecuador, Nigeria, the United Arab Emirates (UAE), and Lebanon.