Bio Solution Discusses Cooperation with the UAE's Medicines Agency... Seeking Entry into the Middle East through Regulatory Diplomacy

[Financial News] Domestic high-tech biotech companies are reducing licensing uncertainties that may arise when entering overseas markets through government-led regulatory diplomacy. Bio Solution is also laying the groundwork for entering the Middle Eastern market by discussing cooperation with regulatory authorities in the United Arab Emirates (UAE).
Bio Solution announced on the 9th that Fatima Al Kaabi, head of the Emirates Drug Establishment (EDE) of the United Arab Emirates, visited the Bio Solution and Helixmith R&D Center in Magok, Seoul, the previous day, toured the production and research facilities, and discussed plans for local cooperation.
The visit took place as part of Korea-UAE biopharmaceutical regulatory cooperation supported by the Ministry of Food and Drug Safety and the Korea Biopharmaceutical Association. Officials from the UAE regulatory authority directly inspected the research and production facilities of domestic biotech companies and reviewed their pipelines and related data.
The EDE delegation reviewed the key research and development activities of Bio Solution and its subsidiary Helixmith at the Magok R&D Center.
Bio Solution introduced technologies related to non-animal methods (NAMs), including the three-dimensional corneal epithelial model 'MCTT HCE model' and the three-dimensional human skin model 'KeraSkin.' Helixmith explained the Chinese approval achievement for 'VM202,' a plasmid DNA-based treatment for severe lower-limb ischemia, as well as the current status of research related to CAR-T cell therapy.
Bio Solution expects that the visit will enable it to review in advance with UAE regulatory authorities the licensing standards for each pipeline and the regulatory requirements needed to enter the local market.
The UAE launched the Emirates Drug Establishment (EDE) as an independent regulatory body in 2025 after reorganizing its legal framework for medical products, with responsibility for drug approvals and Good Manufacturing Practice (GMP). For domestic pharmaceutical and biotech companies seeking to enter the Middle East and North Africa (MENA) market, understanding the UAE's regulatory system and licensing procedures is considered a key task in expanding their local business.
Lee Jung-sun, CEO of Bio Solution, said, "When entering overseas markets, it is important not only to have technological competitiveness but also to meet local regulatory standards." He added, "Taking this visit as an opportunity, we will review licensing materials for each pipeline in advance in line with the UAE's regulatory environment and calmly prepare for entry into the Middle Eastern market."

[email protected] Jeong Sang-hee Reporter