South Korea to Ease Stem Cell Therapy Regulations to Improve Access and Speed up Approvals

In February of this year, South Korea’s “Regenerative Medicine Law” took effect, allowing patients with serious conditions to receive unapproved cell & gene therapies. It came with a variety of strict requirements, seen here. Patients must have serious, rare, and intractable diseases, but, at least from this recent Business Korea article it’s been difficult for patients to meet these conditions, partially because the definition of intractable disease can be unclear. For this reason, many Koreans go abroad to places like Japan, where these therapies are permitted under certain circumstances.

Last week, the South Korean government had a meeting about federal regulations in biotech, energy, and other industries, where stem cell regulation was discussed. Korea JoongAng Daily reports that the government is seeking to broaden access beyond patients with serious illnesses, potentially making stem cell therapy widely available in 2026.

The government will prepare its guidelines by the end of this year, potentially allowing for more leeway on what “intractable disease” means and broadening access to more patients.

Additionally, they’re looking to reduce the time for market approval from 371 to 240 days.