A green light has turned on for Korean pharmaceutical and biotech corporations to tap the Latin American market. As Mexico recognized the Ministery of Food and Drug Safety as a reference regulatory authority for medicines, drugs approved by the Ministery of Food and Drug Safety can obtain local approval through a more streamlined process.
According to the Ministery of Food and Drug Safety on the 23rd, Mexico's Federal Commission for the Protection against Sanitary Risk (COFEPRIS) recently officially recognized the Ministery of Food and Drug Safety as a reference regulatory authority in the field of pharmaceuticals.
Accordingly, medicines approved in Korea can apply for approval using Mexico's abridged regulatory pathway, and the procedures for reviewing quality, safety, and efficacy will also be streamlined.
A reference regulatory authority is an agency internationally recognized for excellent regulatory capacity and review standards. Mexico operates a system that simplifies domestic approval reviews by trusting the approval results of such agencies.
In July last year, Mexico established related rules and introduced an expedited approval system that uses the approval results of regulatory authorities that are founding members or standing members of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and those listed in the World Health Organization (WHO) WHO Listed Authorities (WLA).
In August last year, the Ministery of Food and Drug Safety met the requirement when all functions in the drug and vaccine fields were listed in the WHO Listed Authorities. With this recognition, the Ministery of Food and Drug Safety's approval results will be used as reliable evaluation data in Mexico's marketing authorization review process.
If the abridged regulatory pathway is applied, approval can be decided within up to 45 business days. Mexico's regulatory authority uses the evaluation results conducted by the reference regulatory authority to minimize additional technical assessments or requests for materials and conducts reviews focusing on the completeness of the submitted data.
Mexico also recognizes good manufacturing practice (GMP) compliance certificates issued by regulatory authorities listed in the WLA. Accordingly, domestic corporations can streamline local entry procedures by using GMP compliance certificates issued by the Ministery of Food and Drug Safety.
Mexico is considered the second-largest pharmaceutical market in Latin America after Brazil. The industry expects this measure to help expand Korean pharmaceutical and biotech corporations' entry into the Latin American market and strengthen export competitiveness.
The countries that have designated Korea as a reference country for pharmaceuticals are eight in total: the Philippines, Paraguay, Egypt, Ecuador, Nigeria, the United Arab Emirates (UAE), Lebanon, and Mexico.
Noh Yeon-hong, president of the Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA), said, "Korean pharmaceutical corporations have faced difficulties with approval procedures in the process of entering Mexico, but we expect this measure will make expedited approvals possible."
Oh Yu-Kyoung, head of the Ministery of Food and Drug Safety, said, "Mexico's recognition of the reference regulatory authority once again confirms the excellence and international trust in our regulatory system," adding, "We will continue to expand global regulatory cooperation so that excellent Korean medical products can enter overseas markets more quickly."