Before implementing the regenerative technique, except for the circumstances specified in Article 8, Paragraph 1, human trials must be conducted and completed medical care institutions

A medical care institution can be exempt from completing human trials for regenerative techniques under the following circumstances:
1. Treatment of life-threatening or severely disabling diseases for which no suitable drugs, medical devices, or medical techniques are available in the country.
2. Regenerative techniques that have been approved by the central competent authority for implementation by medical care institutions prior to the enforcement of this Act.
The central competent authority shall announce the conditions, application procedures, case number restrictions, ethical standards, and other regulations for Subparagraph 1 of the preceding paragraph. However, the treatment shall exclude the utilization of xenogeneic cells and tissues.
Before implementing the regenerative technique referred to in Paragraph 1, Subparagraph 1, a medical care institution shall apply to the central competent authority for approval on a case-by-case basis.
A medical care institution implementing regenerative technique under Paragraph 1, Subparagraph 1, shall be exempt from applying for a drug license or conditional authorization according to the Regenerative Medicinal Products Act.

Regenerative medical research involving embryos or embryonic stem cells shall not be conducted in the following methods:
1. Using artificial insemination to generate embryos.
2. Creating hybrids.
3. Introducing the cell nucleus of other species into enucleated human oocytes.
4. Reproducing embryos that have been used for research.
5. Implanting embryos that have been used for research into the uterus of a human or other species.
6. Creating or reproducing chimeric species with human germ cells.
7. Using materials or research methods prohibited by the central competent authority.

The central competent authority or the central competent authority for special purpose undertakings may provide awards or subsidies to support research and development for regenerative medicine.
The methods for the recipients, conditions, application procedures, award or subsidy methods, review criteria, cancellation, and other matters related to the awards or subsidies mentioned in the preceding paragraph shall be determined by the central competent authority in consultation with the central competent authority for special purpose undertakings.