Korea enacts law on regenerative medicine and biopharmaceuticals

The quality, safety, and efficacy of advanced biopharmaceuticals and regenerative medicines produced and marketed in Korea are subject to a series of new regulations and monitoring requirements under a law that went into effect in August.

The Act on the Safety and Support for Advanced Regenerative Medicine and Advanced Biopharmaceuticals, debated for years, is designed to better align Korea with similar regulations in force in Western Europe and the United States.

The law creates definitions of the products and establishes parameters for their clinical research. It also institutes a review committee for business licenses and product approvals, and initiates measures for monitoring and surveillance.