With the rapid development of biotechnology, a regenerative medicine paradigm is emerging as a solution that enables the treatment of root causes by restoring human function by treating, replacing or regenerating damaged tissues and organs. Such regenerative medicine is becoming a future technology that can treat patients who used to be hard-to-cure with conventional therapies, such as patients with rare and incurable diseases and patients with congenital organ defects, etc.

Despite its potential to significantly improve medical technology that has tuned to conservative treatment by serving as a future growth engine for the national economy, regenerative medicne has not been efficiently regulated by the government. Given how fast biotechonolgy is advancing, a flexible regulatry system is needed; but, currently, regenerative medicine treatment technologies and pharmaceuticals are being regulated by the traditional and comprehensive framework of the Medical Service Act and the Pharmaceutical Affairs Act, which do not reflect the distinct characteristics of regenerative medicine.

Since advanced regenerative medicine utilizes substances derived from the human body, it is hard to prove its efficacy or safety even with animal testing so that the existing evaluation method must entail inherent difficulties; and thus, advanced regenerative medicine should be taken differently from existing evaluating methods for medical technology, pharmaceuticals or medical devices.
In addition, since the advanced biopharmaceuticals, which are manufactured using living cells or tissues, have few usage cases around the world and are manufactured mostly in small volumes for specific patients, etc., there are various things to consider unlike conventional synthetic medicines in terms of licensing and safety management; and therefore, it is necessary to establish a separate management system to reflect the characteristics of advanced biopharmaceuticals and flexibly respond to the pace of development in science and technology.
This bill, therefore, prescribes matters concerning the establishment of a management system which covers from clinical research to commercialization in the field of regenerative medicine such as cell, gene, and tissue engineering therapies. In addition, it aims to contribute to promoting the safety and innovation of the regenerative medicine sector and imroving national public health by increasing the possibility of curing patients with rare and previously incurable diseases through the vitalization of clinical research in regenerative medicine and expedited handling for advanced biopharmaceuticals and by strengthening safety management throughout the entire period of the relevant product considering the nature of advanced regenerative medicine and biopharmaceuticals.

Details

A. Definitions (Article 2)
Define the term “advanced regenerative medicine” as cell therapy, gene therapy, etc. using human cells, etc., to regenerate, recover, or reconstruct human body structures or functions, or to cure or prevent diseases; define the term “advanced regenerative medicine practice” as conducting clinical research on advanced regenerative medicine; and define the term "advanced biopharmaceuticals" as cell therapy medicines, gene therapy medicines, and tissue engineering medicines, advanced bio-combination medicines, and other medicines approved by the Minister of Food and Drug Safety

B. Establishment of Basic Plan and Implementation Plan, etc. (from Article 5 to Article 7)

Require the government to establish and implement a basic plan and implementation plan for the support and management of advanced regenerative medicine and advanced biopharmaceuticals; and place the Policy Review Committee under the Minister of Health and Welfare to review policies, etc., for the promotion and safety management of advanced regenerative medicine and advanced biopharmaceuticals

C. Institute for Advanced Regenerative Medicine Practice (Article 11 and Article 12)

Require a medical institution under Article 3 of the Medical Service Act to prepare facilities, equipment and personnel to be designated as an institute for advanced regenerative medicine practice by the Minister of Health and Welfare; and to explain the relevant matters to its patients or research subjects and obtain consent from them in case of a practice of the advanced regenerative medicine

D. Deliberation and approval for Advanced Regenerative Medicine (Article 13)
Require the institute for advanced regenerative medicine practice to prepare a research plan, which shall be deliberated by the review committee, to practice advanced regenerative medicine; provided, however, that the advanced regenerative medicine, which is uncertain about the impact on human life and health shall be designated by Presidential Decree to be approved by the Minister of Food and Drug Safety through deliberation by the review committee

E. Advanced Regenerative Medicine Processing Facilities (Article 16 and Article 17)

Require an advanced regenerative medicine cell processing facility, which performs the affairs of collection, investigation, culture, treatment, and preservation of human cells, etc., to prepare facilities, equipment, and personnel and to obtain a permit from the Minister of Food and Drug Safety

F. Safety Management of Advanced Regenerative Medicine (from Article 18 to Article 20)

1) Place under the Minister of Health and Welfare an entity for safety management of advanced regenerative medicine to ensure the safety of the advanced regenerative medicine, which shall be selected among entities that belong to the Ministry of Health and Welfare

2) Require the entity for safety management of advanced regenerative medicine to carry out inspections for the institute for regenerative medicine and safety monitoring of persons who have received advanced regenerative medicine treatments and report the results to the Minister of Health and Welfare

3) Obligate the entity for safety management of advanced regenerative medicine to conduct a long-term follow-up examination of advanced regenerative medicine practice, which is deemed to be at a high risk, through the deliberation of the review committee and to report the results to the Minister of Health and Welfare

G. Manufacture of Advanced Biopharmaceuticals (from Article 21 to Article 31)

1) Stipulate the approval for manufacturing business, approval for manufacturing or marketing, and matters and requirements necessary for filing reports of contract-manufacturing and marketing business for those who manufacture and sell advanced biopharmaceuticals; and stipulate that the manufacturing or marketing approval shall be renewed every five years, reissued after approval, and reevaluated if necessary

2) Stipulate the approval criteria and requirements for both cases of clinical trials using advanced biopharmaceuticals and the use of advanced biopharmaceuticals for other purposes; and stipulate that necessary measures shall be taken, such as limiting the clinical trial if there are concerns about health and sanitation and stopping the clinical trial if safety and ethical issues are likely to occur

3) Allow the Minister of Food and Drug Safety to examine in advance the standards for preparing documents necessary for marketing approval and approval for a protocol of clinical trials

4) Stipulate that a manufacturer of biopharmaceuticals shall have a manufacturing supervisor who manages their manufacturing operations and a safety control manager who is responsible for post-market safety management affairs; and prescribe the matters to be observed for production and quality control and the obligations to report the results of production, export, and import

5) Require reporting on the discontinuation, suspension, resumption of an advanced biopharmaceuticals manufacturing business, and any change of the manufacturing supervisor and/or safety control manager

A person who intends to practice advanced regenerative medicine shall be designated by the Minister of Health and Welfare as an institute for advanced regenerative medicine practice (Article 11).
A person who intends to practice advanced regenerative medicine shall receive signatures on the written consent including the following from patients or research subjects to whom advanced regenerative medicine shall be practiced prior to practicing the advanced regenerative medicine (Article 12).
The institute for regenerative medicine practice shall prepare and submit a research plan to the review committee for advanced regenerative medicine and advanced biopharmaceuticals, which shall be reviewed by the committee (Article 13).
A person who intends to perform a business providing human cells, etc., to institutes for regenerative medicine by collecting, investigating, culturing, treating, and preserving them shall prepare appropriate facilities, personnel and equipment and obtain permission from the Minister of Food and Drug Safety as an advanced regenerative medicine cell processing facility (Article 16).
The entity for safety management shall carry out the inspection for the institute for regenerative medicine and the safety monitoring on the persons who have received the inspection for the advanced regenerative medicine practice and shall report the results to the Minister of Health and Welfare (Article 19).
When finishing a long-term follow-up examination, the head of the entity for safety management shall report the results to the Minister of Health and Welfare (Article 20).
A person who intends to engage in the business of manufacturing advanced biopharmaceuticals shall obtain permission from the Minister of Food and Drug Safety after preparing necessary facilities in accordance with facility standards (Article 21).
A person who has received marketing approval shall obtain a renewal of the marketing approval from the Minister of Food and Drug Safety to continue to sell such advanced biopharmaceuticals after the expiration date (Article 22).
An advanced biopharmaceutical that has received marketing approval shall be re-examined by the Minister of Food and Drug Safety within the period prescribed by Ordinance of the Prime Minister from the date of marketing approval (Article 23).
A person who intends to conduct clinical trials with advanced biopharmaceuticals shall prepare a protocol and obtain approval from the Minister of Food and Drug Safety (Article 25).
A person who has received marketing approval shall perform post-marketing safety management affairs such as re-examination, re-evaluation, side effect report, etc. of the advanced biopharmaceuticals by separately employing a physician and pharmacist (Article 29).
A manufacturer of advanced biopharmaceuticals or a person who has received marketing approval for advanced biopharmaceuticals shall comply with the following for manufacturing and quality control (Article 30).
Where a manufacturer of advanced biopharmaceuticals or a person who has received marketing approval for advanced biopharmaceuticals falls into the case of suspension or discontinuation of the business, he/she shall report such fact to the Minister of Food and Drug Safety within 7 days (Article 31).
A person who intends to engage in the business of importing advanced biopharmaceuticals shall file a report on importation business with the Minister of Food and Drug Safety and shall obtain marketing approval from the Minister of Food and Drug Safety for each product, as prescribed by Ordinance of the Prime Minister (Article 32).
A person who intends to engage in the management business of advanced biopharmaceutical cells, etc., shall receive an approval from the Minister of Food and Drug Safety for the following after preparing facilities, equipment, personnel and quality control system designated by Presidential Decree (Article 33).
Human cells, etc., shall be collected by medical personnel under the supervision of a physician or directly by a physician at a medical institution (Article 34).
Matters to be observed by management contractor of advanced biopharmaceutical cells, etc. (Article 36).
A person who has been approved for a protocol of clinical trials and a person or importer who has received marketing approval for advanced biopharmaceuticals shall investigate and analyze serious anomalies in patients who are administered advanced biopharmaceuticals subject to long-term follow up examination and shall report such findings to the Minister of Food and Drug Safety in compliance with the long-term follow up examination plan or risk management plan (Article 37).
A person or an importer who has received marketing approval for advanced biopharmaceuticals shall indicate the product name, etc., on the containers or packages of advanced biopharmaceuticals (Article 38).
Labeling of Outside Packages (Article 39)
Information in Package Inserts of Advanced Biopharmaceuticals (Article 40)
Package Inserts of Advanced Biopharmaceuticals or Information Prohibited from Being Indicated on Containers or Packages (Article 42)
Reporting, Inspection, etc. (Article 51)
Order, etc. of Recall and Abandonment (Article 53)
Correction Order (Article 54)
Revocation of Permission, etc. and Suspension of Business (Article 55)
Reporting on Discontinuation, etc. of Business and Transfer of Information (Article 57)
Disposition of Penalty Surcharges (Article 58)
Prohibition of False and Exaggerated Advertisement, etc. (Article 61)
Preventing Leakage of Confidential Information, etc. (Article 62)
Prohibition of Human Cells Trafficking (Article 65)
Prohibition against Use of Similar Names (Article 66)