The Advanced Regenerative Medicine and Advanced Biopharmaceuticals Safety and Support Act (abbreviation is “Advanced Regeneration Bio Act.”) and the subordinate Enforcement Decree became effective as of 28 August 2020.
The Enforcement Decree of Advanced Regenerative Medicine and Advanced Biopharmaceuticals Safety and Support Act was recently legislated to stipulate the detailed authority delegated by the law to enforce the “Advanced Regenerative Bio Act,” and the main contents of the legislated Enforcement Decree are as follows:
[1] Definitions including the scope of advanced regenerative medicine and human cells
○ (Scope of advanced regenerative medicine) Classified into four therapy types comprised of cell therapy, gene therapy, tissue engineering, and fusion therapy
○ (Scope of human cells) Cells and tissues originated from humans or animals, or those treated with methods such as cell manipulation, cell processing, and cell manufacturing
○ (Risks of clinical studies) Provide medical institutions with standards for self-assessment of risks to refer to when devising research plans.
[2] Establishment of Basic Plan
○ (Basic plan) Outlines the first quintennial Basic Plan for Advanced Regenerative Medicine and Advanced Biopharmaceuticals and procedures for the establishment of its annual implementation plan, related government departments, operation of a policy review committee for cross-governmental public-private cooperation in governance, among others
[3] Launching clinical studies in the advanced regenerative medicine
○ (Institutions for regenerative medicine) Specifies research plan documentation, submission methods, and required documents among other matters in regard to application procedures and methods for research plan reviews
○ (Reviews by the Review Committee) Prescribes review process for research plans submitted by regenerative medicine institutions
.(Establishment of the expert subcommittee under the review committee) To conduct reviews in a more professional manner, 4 expert subcommittees will be established for each of the four treatment types. The subcommittees will be in charge of writing review reports on the efficacy, safety, and ethical legitimacy of research plans for advanced regenerative medicine.
.. (Establishment of review committee secretariat) general management of review committee affairs including the registration of research plans, organization of review committee meetings, and the announcement of review results
○ (Cell processing facilities) specify requirements for facilities, equipment, and human resources for the approval as cell processing facilities and rules such as the obligation to record and report during cell processing
○ (Safety management institutions) the establishment and operation of an information system for a systematic and collection and management of clinical trial data generated by regenerative medicine institutions and the establishment of plans for patient(test subjects) safety management and long-term follow-up surveys
[4] Strengthening of management system suited for the characteristics of advanced biopharmaceuticals
○ (Standards for advanced biopharmaceutical manufacturing and importing facilities) define standards for facilities such as establishments, storage, laboratories, and record rooms needed for approval and reporting.
○ (Requirements for the approval of human cell management business) provide requirements on facilities, equipment, human resources set out for the approval and define the elements of the quality management system.
○ (Long-term follow-up investigation on advanced biopharmaceuticals) set out procedures for selecting products that need to be monitored through long-term follow-up investigations, for reporting adverse cases, and for registering dosage records.
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