UAE drug regulators meet with Korean industry

Officials tour Bio Solution, Helixmith R&D centers

Shamsa Atiq Al Muheiri, adviser to the IMC chairperson at the UAE's Emirates Drug Establishment (EDE), Fatima Al Kaabi, director general of the EDE, An Young-jin, director of the Biopharmaceuticals Bureau at South Korea's Ministry of Food and Drug Safety, Lim Sang-woo, head of the ministry's Biopharmaceutical Quality Control Division, and Lee Jung-sun, CEO of Bio Solution, among others, attend a meeting on Tuesday. (Bio Solution)
Shamsa Atiq Al Muheiri, adviser to the IMC chairperson at the UAE's Emirates Drug Establishment (EDE), Fatima Al Kaabi, director general of the EDE, An Young-jin, director of the Biopharmaceuticals Bureau at South Korea's Ministry of Food and Drug Safety, Lim Sang-woo, head of the ministry's Biopharmaceutical Quality Control Division, and Lee Jung-sun, CEO of Bio Solution, among others, attend a meeting on Tuesday. (Bio Solution)

Attention is turning to whether Korean cell and gene therapy (CGT) companies can accelerate their entry into the UAE market. South Korea's Ministry of Food and Drug Safety has been pursuing regulatory cooperation on biopharmaceuticals with the UAE's Emirates Drug Establishment (EDE). As part of that effort, a meeting with senior UAE regulatory officials was held in Korea.

The meeting, hosted by the Korea Biopharmaceutical Association on Tuesday, brought together Korean CGT companies including Bio Solution and Helixmith. Participants then visited the Bio Solution and Helixmith R&D centers in Seoul's Magok district to discuss further cooperation.

The attending companies presented their flagship CGT products and pipelines, discussed the regulatory environment and mutual cooperation needed for UAE market entry, and toured Bio Solution's research and production facilities.

Bio Solution and Helixmith unveiled their commercialized and clinical-stage cell and gene therapies, along with proprietary technologies developed in-house. Bio Solution introduced its human tissue-mimicking technologies for animal-free testing, including the three-dimensional corneal epithelial model MCTT HCE and the three-dimensional human skin model KeraSkin. The company also presented progress on developing a gene therapy for critical limb ischemia (CLI) using its subsidiary Helixmith's DNA-based therapeutic VM202, as well as the therapy's product approval in China.

Under a new medical products legal framework introduced in the UAE in 2025, the EDE now oversees all licensing and regulatory functions, including drug approvals and Good Manufacturing Practice (GMP) standards. This makes regulatory harmonization and network-building with the EDE a prerequisite for Korean biotech companies seeking to enter the UAE market.

A Bio Solution official said, "Our company and our subsidiary Helixmith possess a range of advanced biotechnologies, including CGT platforms and human tissue models. We will work to ensure this translates into real business opportunities."


freiheit@heraldcorp.com