Advanced biopharmaceuticals, including cell therapies and gene therapies, will be allowed to be used for the treatment of severe and rare refractory diseases. This is expected to lead to product development of domestic corporations, which have been hindered by regulations, and the development of new treatment methods for refractory patients.
The Ministry of Health and Welfare announced that it held a joint briefing with relevant ministries on the 'advanced regenerative medical treatment system' at the Korea Press Center in Jung-gu, Seoul, on the 19th.
An amendment to the 'Act on the Safety and Support of Advanced Regenerative Medicine and Advanced Biopharmaceuticals (Act on Regenerative Medicine)' that permits the use of advanced biopharmaceuticals under clinical trials for therapeutic purposes will come into effect on the 21st. The advanced regenerative medical treatment system allows medical technologies verified through clinical research to be utilized for disease treatment after review by an expert committee on advanced regenerative biomedicine. Regenerative medicine refers to cell therapy, gene therapy, and tissue engineering using human cells.
The event was attended by the Ministry of Health and Welfare, as well as the Food and Drug Safety Agency, the National Health Research Institute, the review committee, and the Regenerative Medicine Advancement Foundation, which provided guidance on the procedures and preparations for advanced regenerative medical treatments.
First, medical institutions wishing to perform advanced regenerative medical treatments must prepare facilities, equipment, and personnel requirements in advance and receive designation as a treatment institution from the Minister of Health and Welfare. After designation as a treatment institution, they must submit evidentiary materials regarding the purpose and targets of treatment, safety, efficacy, and expense to the review committee for suitability assessment. Medical institutions that pass the review will be allowed to provide treatment for the duration specified in their plan.
Shin Kkot-sigye, an official from the Ministry of Health and Welfare's advanced medical support office, noted, 'We expect that the advanced regenerative medical treatment system will provide new treatment opportunities for patients,' and added, 'We will reorganize and strengthen the management system to ensure that patients utilizing advanced regenerative medicine can receive treatment safely.'