Health Ministry eases biotech regulations to boost investment in special zones

The Ministry of Health and Welfare announced Sunday that it has stepped up support for the biotech industry over the past year under the Lee Jae-myung administration, easing regulations to accelerate the growth of new businesses in the sector and strengthen South Korea's position in global markets.

The ministry said its regulatory reform efforts over the past year focused particularly on advanced regenerative medicine and medical data.

Advanced regenerative medicine had previously allowed stem cell treatments, but eligible conditions were limited to serious, rare and intractable diseases — a category whose definition was vague enough to discourage applications.

To give researchers more flexibility in determining whether a condition qualifies as intractable, the government provided a reference list of 82 diseases and revised its guidelines to no longer require preclinical data at the level demanded for high-risk research when the study itself carries only low or moderate risk.

An amendment to the Act on Safety and Support for Advanced Regenerative Medicine and Advanced Biopharmaceuticals, which passed the National Assembly plenary session last month, adds genetic material to the definition of human cells and similar substances, bringing in vivo gene therapy within the scope of advanced regenerative medicine.

The ministry also worked with the Personal Information Protection Commission to clarify guidelines on the use of data from deceased individuals and developed a "low-risk pseudonymized dataset" with strengthened measures to prevent personal identification.

Deceased patients' medical data are considered important indicators for verifying the efficacy of new drugs, but researchers had long struggled to determine whether such data had been sufficiently de-identified, limiting its practical use.

Alongside this, the ministry drew up a plan to establish sector-specific mega special zones linked to the national balanced growth strategy. For advanced complex facilities within those zones, it will ease restrictions on the scale of pharmaceutical and medical device production facilities and permit the installation of health functional food and functional cosmetics production facilities as well.

The ministry also plans to allow special zones to operate their own regional advanced regenerative bio review committees and separate safety management bodies, moving away from the uniform procedures of the current central review committee. It also intends to ease the requirements for administering advanced regenerative medicine treatments within the zones.

"We are lowering the barriers to advanced regenerative medicine treatments that have long been underutilized, opening up new treatment opportunities for patients with serious, rare and intractable diseases," Health Minister Jeong Eun-kyeong said. "We will boldly introduce regulatory exceptions centered on the bio mega special zones to invigorate corporate investment."