The Ministry of Food and Drug
Safety and the Ministry of Health and Welfare announced on the 25th that the
enactment of the Enforcement Decree of ‘The Act on the Safety and Support of
Advanced Regenerative Medicine and Advanced Biopharmaceuticals' has passed the
cabinet meeting.
The Advanced Regenerative Bio Act is a bill created to more systematically
manage biopharmaceuticals made by culturing or editing living cells, and to
support the development of innovative medicines that cure diseases that have
not been curable.
This decree divided the scope of advanced regenerative medicine into four
categories: cell therapy, gene therapy, tissue engineering therapy, and
convergence therapy.
In addition, it stipulated the procedure for establishing an annual implementation
plan, the operation of the policy review committee, which is a government-wide
public-private partnership, and the basic plan for advanced renewable bio,
which is scheduled to be established every five years.
Also, this decree stated specific procedures and methods necessary for the
creation of a research plan for regenerative medical institutions and
application for deliberation for the conduct of advanced regenerative medicine
clinical research.
The Ministry of Health and Welfare said, "In a situation where it is
difficult to carry out work due to the COVID-19, we have focused on preparing
the subordinate laws, essential organizations, and budgets necessary for the
enforcement of the law.”
In response, stem cell
treatment-related bio companies are regrettable that the enforcement decree was
enacted later than expected, but it certainly had an encouraging aspect since the
regulatory uncertainty was resolved.