The Ministry of Food and Drug Safety (MFDS) is partnering with regulatory agencies in the United Arab Emirates (UAE) to support the expansion of K-Bio into the Middle East.
On September 8, the MFDS announced it will hold a meeting with a delegation of seven members, including Fatima Al Kaabi, head of the UAE's medical product regulatory agency (EDE), to assist domestic bio companies in entering the UAE market.
The MFDS stated, "We are strengthening regulatory cooperation in the biopharmaceutical sector with the UAE while creating practical opportunities for domestic companies looking to enter the Middle Eastern market by facilitating direct communication with EDE."
The meeting will include An Young-jin, head of the MFDS's Bio-Pharmaceutical Bureau, and representatives from four domestic companies: BioSolution, Corestem ChemOn, Cha Bio & Diostech, and Organoid Science.
Domestic companies will present their key products and technologies, as well as their plans for entering the UAE market, directly to EDE. They will also engage in a Q&A session regarding the regulatory procedures and requirements for market entry in the UAE.
Additionally, the EDE delegation plans to visit cell and gene therapy (CGT) research facilities after the meeting. They will examine the research environment, key facilities, and equipment related to cell therapy research and development, assessing the technological level of South Korea's advanced biopharmaceuticals.
The MFDS emphasized, "We will continue to actively promote field-oriented regulatory diplomacy that connects our cooperation network with foreign regulatory agencies to create practical export opportunities for our companies and support the global market entry of K-Bio."
Previously, the MFDS was officially recognized as a reference agency in the medical product sector by the UAE's EDE.
This recognition allows the MFDS to submit applications for UAE approvals without needing approvals from the United States or Europe, streamlining the certification process and reducing the time required.
Currently, the countries recognized by the UAE as reference agencies include the United States, Europe, the United Kingdom, Canada, Japan, Australia, and the GCC.
* This article has been translated by AI.
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