UAE Grants MFDS Reference Status, Opening Arab Markets

South Korea’s Ministry of Food and Drug Safety (MFDS) has been designated a reference regulatory authority by the United Arab Emirates (UAE), following similar recognitions by Ecuador and Egypt. The milestone reflects MFDS’s full-function listing under the World Health Organization’s WHO Listed Authorities (WLA) framework and sustained regulatory diplomacy, with industry viewing the UAE as a strategic gateway to broader Arab markets.

MFDS previously announced that the UAE’s medical products regulator, the Emirates Drug Establishment (EDE), had officially designated South Korea as a reference authority for medical products. Responding to inquiries from the pharmaceutical trade press on January 27, MFDS’s Global Export Strategy Division said the decision was driven by international recognition of MFDS’s regulatory capacity, particularly its comprehensive WLA listing covering vaccines and pharmaceuticals.

In August, MFDS achieved full listing across all eight functional areas under the WHO WLA framework: pharmacovigilance; licensing of manufacturers and importers; regulatory inspections; testing and laboratory analysis; clinical trials; national lot release; product authorization; and market surveillance.

Joo-hyun Baek, a senior researcher in MFDS’s Pharmaceutical Policy Division who led the WLA listing process, explained that the WLA system evaluates whether regulatory functions for medicines and vaccines meet international standards through a phased and objective assessment. He noted that South Korea successfully gained recognition across all functions. Baek added that the previous Stringent Regulatory Authority (SRA) designation—applied to certain ICH members or mutual recognition agreement partners before October 2015—had faced criticism over objectivity and transparency, prompting the WHO to introduce the WLA framework.

Industry sources pointed in particular to MFDS’s successful listing in registration and marketing authorization and in market surveillance and control as decisive factors behind the UAE’s move. A regulatory affairs official said UAE authorities likely placed high value on MFDS’s status in registration and marketing authorization, as WLA recognition in this area directly affects eligibility for fast-track benefits such as reduced documentation requirements.

MFDS also highlighted the role of Commissioner Yu-kyoung Oh’s diplomatic engagement. Since the establishment of the EDE in 2024, MFDS has expanded regulatory cooperation through director-level meetings, reciprocal participation in international symposia, and working-level video conferences. Commissioner Oh later proposed MFDS’s inclusion on the UAE’s reference authority list during meetings with UAE ministers and visited the country around a 2025 summit, where the two agencies signed a memorandum of understanding. According to MFDS, these efforts—along with demonstrated regulatory capabilities and the quality competitiveness of Korean pharmaceuticals—ultimately led to the expedited designation.

Looking ahead, MFDS expects pharmaceutical exports to the UAE and the wider Arab region to increase. An official from the Global Export Strategy Division explained that UAE marketing authorization applications previously required prior approval from regulators such as the U.S. Food and Drug Administration or the European Medicines Agency. Following the designation, approval by MFDS alone is sufficient to apply in the UAE, a change expected to shorten review timelines, simplify procedures, and exempt manufacturers from facility inspections.

Industry stakeholders also described the recognition as a catalyst for broader Middle East expansion. A representative from the Korea Pharmaceutical and Bio-Pharma Manufacturers Association said that while the UAE market is smaller than Saudi Arabia’s, its openness and regulatory environment make it a strategic hub for entry into the Middle East and North Africa. The designation is viewed as a first breakthrough in the Arab region and a foundation for further reference authority recognition and sequential market entry, including into Saudi Arabia.