Major Content of Lower Statute of “ACT ON THE SAFETY OF AND SUPPORT FOR ADVANCED REGENERATIVE MEDICINE AND ADVANCED BIOPHARMACEUTICALS”

Pre-announcement of legislation of lower statute for the implementation of the Advanced Regenerative Bio Act (4/21 to 6/1) approval

Major Contents of Lower Statute of Advanced Regenerative Bio Act
Secure the patient safeguards by supporting the swift commercialization of advanced biopharmaceuticals and implementing the whole-life-cycle safety management system

1) Prepared a safety management system for advanced biopharmaceuticals
- Prepared facility/equipment/personnel standards necessary for human cell management business* approval, and specified matters to include in the quality management system
*Newly established business type that supplies human cells to be used as ingredients in advanced biopharmaceuticals
- Prepared blood tests/microorganism tests standards for suitable and unsuitable donors for collecting cells/tissue
- Prepared quality and safety management standards by stages of collection, processing, testing, and supplying for human cells

2) Designated regulatory science center and prepared detailed procedures
- Reported adverse events and prepared procedures for registering drug administration history by designating the advanced biopharmaceuticals* that require long-term surveillance
*Can designate stem cell treatments, medicine containing animal tissue/cells, gene therapy products
- Specified necessary items such as follow-up purpose/period/items and compliances for longer-term follow-ups when establishing long-term follow-up plans
- Designated Korea Institute of Drug Safety & Risk Management as a regulatory science center and specified the tasks of the regulatory science center*
*Examination and verification after performing long-term follow-up plans for advanced biopharmaceuticals and installation/operation of a committee, adverse causality investigations, and safety information management system construction/operation.

3) Designation of targets for quick approvals and customized examination and conditional approval for quick approval
- Specified procedures necessary for designating targets for quick processing and customized examination and conditional approval procedures for the targeted advanced biopharmaceuticals
*Can designate drugs with the purpose of treating serious diseases in which no alternative treatment drugs are available and is life-threatening, treating rare diseases, and preventing the spread of and treating infectious diseases

Approval/Examination Support System of Advanced Bio-pharmaceuticals
[Customized Examination] Preliminary examination by receiving approval documentation in advance according to the developer's schedule
1) Non-clinical
2) Clinical trial
3) Standards and testing method data
4) Hazard management plan
5) Evaluation data on the execution of manufacturing and quality management standards
[Priority Screening] Quicker examination and reduction of civil petition processing compared to other drugs by designating personnel exclusive for the task (115 days -> 90 days)
[Conditional Approval] Approval with Phase 2 data on the condition that a therapeutic confirmation (Phase 3) clinical trial will be performed after commercialization to expand treatment opportunities for patients with cancer and rare diseases.

Please refer to the Press Release on April 22, 2020 for more information.