What is MFDS? South Korea's International Safety Standards for Cell Therapy Regulation

The Role of MFDS in the Biotechnology Industry

MFDS, or the Ministry of Food and Drug Safety, is the primary government agency of the Republic of Korea tasked with overseeing public health by verifying the safety and efficacy of biological products. Particularly in modern regenerative medicine, MFDS plays a vital role in auditing production processes, cell isolation, and stem cell storage according to standards. This ensures that recipients receive quality products with safety standards as assessed by the EHL team.

EHL BIO’s operations are strictly regulated by MFDS, especially in compliance with the Advanced Regenerative Bio Act. This legislation sets transparent and systematic standards for human cell management, covering everything from sample collection and laboratory testing to the cultivation processes in our state-of-the-art GMP facilities.

Clinical Trial Approval (IND): International Trust

One of the most critical functions of MFDS is reviewing and approving Investigational New Drug (IND) applications to verify medical outcomes. EHL BIO products have consistently gained MFDS recognition, such as ADSTEM Inj., which received approval for Phase 3 clinical trials for atopic dermatitis, and KDSTEM Inj., approved for Phase 1 in chronic kidney disease.

Having an IND approved by MFDS confirms that EHL BIO’s pre-clinical research and initial safety data are reliable and possess sufficient potential to be developed into future care standards. This provides clients and their families with confidence in the innovations we develop under national-level scrutiny.

Safety and international quality standards regulated by MFDS are essential to delivering regenerative medicine innovations for a better quality of life.

GMP Standards and MFDS-Certified Quality Control

MFDS establishes and audits GMP (Good Manufacturing Practices) standards, which are at the heart of EHL BIO. Our research and cell production centers undergo MFDS inspections to ensure appropriate facilities, such as Class 100 Clean Rooms and stable cell storage systems. We have the capacity to culture 6,000 lots per year, with every step controlled to promote quality and maintain cell viability at a good level.

Furthermore, EHL BIO was the first in Korea to be licensed as a 'Human Cell Management Business' by MFDS. This certification confirms our readiness in all dimensions, including our team of over 85 researchers, comprehensive scientific equipment, and processes that comply with both ethical and professional regulations.

Advancing to Quality Standards with Leading Certifications

The stringency of MFDS helps South Korean technology achieve international recognition. EHL BIO meets MFDS criteria and has expanded its partnership network to over 100 hospitals in Korea, including Thailand through the EHL Thailand coordination team.

EHL BIO’s goal is to utilize these certified standards for the goal of recovery and quality of life for clients (Aging Well). We focus on confidence at every stage—from initial consultation and medical evaluation to post-service follow-ups—ensuring that physical care via stem cells and immune cells follows an appropriately planned and safe path as assessed by the EHL team.