Adding to a number of cutting-edge biologics that have been approved in South Korea this year, the country has just given regulatory clearance to the first study with a regenerative medicine under new legislation implemented in September 2020 to support the development of such novel therapies.
The government has been putting a focus on fostering this type of "cutting-edge" product, which it defines as cell and gene therapies, tissue-engineered products, biotechnology-convergence products using multiple technologies (excluding those whose main function is as a medical device), and other therapies that contain cell, tissue or gene components