The new business entities should stop the supply and sale of human cells once they are verified to be harmful to human bodies. (Yonhap)
SEOUL, July 16 (Korea Bizwire) — New government regulations will require South Korean biotech companies to track and monitor patients who are injected with stem cells or gene therapy treatments.
According to the Ministry of Food and Drug Safety on Wednesday, the Advanced Regenerative Bio Act, enacted to strengthen the safety management of advanced regenerative drugs as well as to facilitate their commercialization through rapid clinical studies, will take effect on Aug. 28.
Under this law, a new type of business called “human cell management” will be born, which will clear the way for professional management of human and animal cells and tissues in addition to animal organs.
During the process of operation, the new business entities should stop the supply and sale of human cells once they are verified to be harmful to human bodies.
In such cases, all of the human cells concerned should be withdrawn and disposed of.
The law will make it mandatory for biotech companies to register stem cell and gene therapy treatment injection data with the Korea Institute of Drug Safety & Risk Management.
They will also be obliged to report unusual cases and perform long-term tracking and monitoring of the patients.
Advanced regenerative medicine refers to the medical technology of curing, replacing or regenerating damaged cells or issues using human cells.
Kevin Lee (kevinlee@koreabizwire.com)
