Mexico has officially recognized South Korea’s Ministry of Food and Drug Safety (MFDS) as a Reference Regulatory Authority for Pharmaceuticals.
The MFDS announced on Tueday that Mexico’s Federal Commission for the Protection against Sanitary Risk (COFEPRIS) has formally acknowledged the MFDS as a reference regulatory authority in the pharmaceutical sector.
This recognition allows drugs approved in South Korea to apply for product licenses in Mexico through an Abbreviated Regulatory Pathway. The streamlined process is expected to simplify technical reviews of quality, safety, and efficacy, potentially reducing approval timelines.
Mexican regulators operate an expedited approval system that trusts regulatory decisions from agencies that are founding or permanent members of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), or those listed in the World Health Organization’s (WHO) List of Stringent Regulatory Authorities. The MFDS solidified its international regulatory credibility last year when its pharmaceutical and vaccine functions were included in the WHO’s list.
As a result, drug applications based on MFDS approvals could receive decisions in Mexico within 45 business days. Mexican authorities can now focus on reviewing the completeness of submitted documents, leveraging the MFDS’s assessment results without requiring additional technical evaluations or data.
Moreover, Mexico recognizes Good Manufacturing Practice (GMP) certificates issued by regulatory bodies with inspection capabilities listed in the WHO’s recognized authorities. This allows South Korean companies to utilize MFDS-issued GMP certificates in their Mexican applications.
Mexico represents the second-largest pharmaceutical market in Latin America, trailing only Brazil. The MFDS believes this development will boost South Korean pharmaceutical companies’ competitiveness and expand their presence in the Latin American market. Industry insiders view this as a significant opportunity for growth in the region.
Mexico’s recognition of the MFDS as a reference regulatory authority underscores the excellence of the regulatory system and reaffirms international trust in the processes, said the MFDS Commissioner. It will continue to expand global regulatory cooperation to ensure that high-quality South Korean medical products can enter overseas markets more efficiently.
Oh Yun-hong, Chairman of the Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA) commented that South Korean pharmaceutical companies have faced hurdles in the Mexican approval process, but this measure should enable faster approvals. It hopes this will catalyze further expansion into the Latin American market, including Mexico.
Mexico is now the eighth country to recognize the MFDS as a reference regulatory authority, joining the Philippines, Paraguay, Egypt, Ecuador, Nigeria, the United Arab Emirates (UAE), and Lebanon.