ACT ON REGULATORY SCIENCE INNOVATION FOR SUPPORTING FOOD AND DRUG SAFETY AND COMMERCIALIZATION
Presidential Decree No. 34207, Feb. 6, 2024
Amended by Presidential Decree No. 35842, Nov. 4, 2025
Presidential Decree No. 36055, Jan. 27, 2026
CHAPTER I GENERAL PROVISIONS
| Article 2 (Scope of food and drugs) |
CHAPTER II FORMULATION OF MASTER PLANS FOR REGULATIONAL SCIENCE INNOVATION
| Article 3 (Formulation of master plans for regulatory science innovation) |
If the Minister of Food and Drug Safety formulates a master plan for regulatory science innovation under Article 5(1) of the Act (hereinafter referred to as "master plan"), he or she shall notify the heads of relevant central administrative agencies thereof and post the details thereof on the website, etc. of the Ministry of Food and Drug Safety.
| Article 4 (Formulation of annual action plans) |
| (1) | If the Minister of Food and Drug Safety formulates an annual action plan under Article 5(4) of the Act (hereinafter referred to as "action plan"), he or she shall submit it for deliberation by the Regulatory Science Innovation Committee for Foods and Drugs under Article 6(1) of the Act. |
| (2) | An action plan shall include the following matters: |
| 1. | Directions for the promotion of regulatory science innovation by year and by field and strategies therefor; |
| 2. | Detailed tasks and action plans by year and by field for regulatory science innovation; |
| 3. | Investment plans for a research and development program under Article 7(1) of the Act (hereinafter referred to as "research and development program"); |
| 4. | Matters regarding cooperation among relevant agencies for promoting research and development programs; |
| 5. | Other matters deemed necessary by the Minister of Food and Drug Safety to implement a master plan. |
| (3) | If necessary to formulate an action plan, the Minister of Food and Drug Safety may request the heads of relevant central administrative agencies, the heads of local governments, the heads of enterprises, educational institutions, research institutes, and the heads of institutions and organizations related to regulatory science innovation to provide cooperation, such as submission of necessary data. |
| (4) | Except as provided in paragraphs (1) through (3), details necessary for formulating and implementing action plans shall be determined by the Minister of Food and Drug Safety. |
| Article 5 (Composition of Regulatory Science Innovation Committee for Foods and Drugs) |
| (1) | The Regulatory Science Innovation Committee for Foods and Drugs under Article 6(1) of the Act (hereinafter referred to as the "Committee") shall be comprised of up to 30 members, including one chairperson. |
| (2) | The Minister of Food and Drug Safety shall serve as the chairperson of the Committee, and the following persons shall serve as members of the Committee: |
| 1. | Persons in a position designated by the Minister of Food and Drug Safety from among public officials belonging to the Senior Executive Service of the Ministry of Food and Drug Safety; |
| 2. | Persons commissioned by the Minister of Food and Drug Safety in consideration of gender, from among persons with extensive knowledge of and experience in regulatory science (hereinafter referred to as "regulatory science") or regulatory science innovation of innovation of food, drugs, etc. |
| Article 6 (Term of office of members) |
The term of office of a member commissioned pursuant to Article 5(2)2 (hereinafter referred to as "commissioned member") shall be two years; provided, the term of office of a member newly commissioned due to the resignation, etc. of a commissioned member shall be the remainder of his or her predecessor's term of office.
| Article 7 (Dismissal of members) |
If a commissioned member of the Committee falls under any of the following cases, the Minister of Food and Drug Safety may dismiss the relevant member:
| 1. | Where he or she becomes incapable of performing his or her duties due to mental or physical disability; |
| 2. | Where a member commits a misdeed in connection with his or her duties; |
| 3. | Where he or she is found unfit for office due to neglect of duties, injury to dignity, or any other reason; |
| 4. | Where he or she fails to recuse himself or herself from participating in deliberation and resolution despite falling under any subparagraph of Article 8(1); |
| 5. | Where he or she voluntarily indicates that it is impracticable to perform his or her duties. |
| Article 8 (Exclusion of, challenge to, or recusal of members) |
| (1) | Where a member of the Committee falls under any of the following cases, he or she shall be excluded from deliberation and resolution by the Committee: |
| 1. | Where a member, or his or her spouse or his or her former spouse is a party to the relevant agenda item (including the executive officer or employee thereof if the party is a corporation, organization, etc.; hereinafter the same shall apply in this subparagraph and subparagraph 2), or is a party and joint holder of rights or joint obligor of the agenda item; |
| 2. | Where a member is or was in a relative of a party to the relevant agenda item; |
| 3. | Where a member or any corporation, organization, etc. to which a member belongs has given testimony, made a statement, consulted on, researched, provided services for, or appraised, the relevant agenda item; |
| 4. | Where a member or the corporation, organization, etc. to which the member belongs is or was an agent for a party to the relevant agenda item; |
| 5. | Where a member has served in the corporation, organization, etc. that is a party to the relevant agenda item as an executive officer or employee thereof during the latest three years; |
| (2) | Where any ground for exclusion referred to in paragraph (1) exists with respect to a member, or the circumstances indicate that it would be impracticable to expect a fair deliberation or resolution from a member, any party may file a challenge with the Committee, and the Committee shall make a determination on the challenge by its resolution. In such cases, the member to whom a challenge is made shall not participate in the resolution on the relevant case. |
| (3) | Where a member of the Committee falls under any of the grounds referred to in paragraph (1) or (2), he or she shall recuse himself or herself from deliberation or resolution on the relevant agenda item. |
| Article 9 (Duties of chairperson) |
| (1) | The chairperson shall represent the Committee and have general supervision and control of its business affairs. |
| (2) | When the chairperson is unable to perform his or her duties in unavoidable circumstances, a member of the Committee pre-nominated by the chairperson shall act on his or her behalf. |
| (1) | Meetings of the Committee shall be convened as deemed necessary by the chairperson. |
| (2) | A majority of the members of the Committee shall constitute a quorum, and any resolution thereof shall require the concurring vote of a majority of those present. |
| Article 11 (Subcommittees and research members) |
| (1) | The Committee may establish subcommittees for each specialized field within the Committee, as deemed necessary to efficiently perform its business affairs. |
| (2) | The Committee may have up to five research members in the Committee, as deemed necessary for specialized surveys and research on matters to be deliberated upon by the Committee. |
| (3) | Research members under paragraph (2) shall be appointed by the Minister of Food and Drug Safety from among persons with expertise in the field of regulatory science or regulatory science innovation. |
| Article 12 (Hearing of opinions) |
If the chairperson deems it necessary for the efficient deliberation of the Committee, he or she may have public officials of relevant agencies, experts, etc. attend a meeting to hear their opinions.
| Article 13 (Administrative secretary) |
| (1) | One administrative secretary shall be appointed to process the business affairs of the Committee. |
| (2) | The administrative secretary shall be appointed by the Minister of Food and Drug Safety from among public officials of the Ministry of Food and Drug Safety. |
Allowances and travel expenses may be paid to members, etc. of the Committee or subcommittee who attend a meeting of the Committee or subcommittee or review agenda items, within the budget; provided, this shall not apply where a public official attends a meeting of the Committee or reviews agenda items in direct connection with his or her business affairs.
| Article 15 (Detailed rules of operation) |
Except as provided in Articles 5 through 14, matters necessary for the composition, operation, etc. of the Committee and subcommittees shall be determined by the chairperson following a resolution by the Committee.
CHAPTER III PROMOTION OF RESEARCH AND DEVELOPMENT PROGRAMS
| Article 16 (Methods of selecting research subjects and executing agreements) |
| (2) | Meeting minutes prepared under Article 7(2) of the Act shall contain the following matters: |
| 1. | Matters regarding the scope of research tasks, methods of performing research tasks, and research directors; |
| 2. | Matters regarding the payment method, use, and management of research and development expenses; |
| 3. | Matters regarding reporting on results of performing research tasks; |
| 4. | Matters regarding vesting and utilizing the outcomes of research and development programs; |
| 5. | Matters regarding the evaluation of outcomes of research and development programs and measures therefor; |
| 6. | Matters regarding compliance with research ethics; |
| 7. | Matters regarding changing or canceling agreements; |
| 8. | Other matters incidental to performing research tasks. |
| (3) | Except as provided in paragraphs (1) and (2), matters necessary for the methods of selecting research tasks and executing agreements shall be prescribed by Prime Ministerial Decree. |
| Article 17 (Standards for company-affiliated research institutes) |
| (1) | "Company-affiliated research institute that satisfies the standards prescribed by Presidential Decree" in Article 7(2)5 of the Act means a company-affiliated research institute meeting all of the following standards: <Amended on Jan. 27, 2026> |
| 1. | It shall be a business-affiliated research institute recognized by the Minister of Science and ICT under Article 7(1) of the Act on Support for Research and Development of Business-Affiliated Research Institutes; |
| 2. | It shall have at least five researchers in the field of regulatory science or regulatory science innovation. In such cases, at least two persons with at least three years of research experience in the relevant field shall be included therein. |
| (2) | "Research institute that satisfies the standards prescribed by Presidential Decree" in Article 7(2)6 of the Act means a research institute meeting the standards prescribed in paragraph (1)2 of this Article. |
| (3) | "Research institutes or organizations ... that satisfy the requirements prescribed by Presidential Decree" in Article 7(2)7 of the Act means research institutes or organizations that meet the standards prescribed in paragraph (1)2 of this Article. |
| Article 18 (Specialized institutions for planning and managing research and development programs on behalf of others) |
| (1) | "Institution or organization prescribed by Presidential Decree" in the provisions, with the exception of the subparagraphs, of Article 7(4) of the Act means any of the following institutions or organizations (hereinafter referred to as "specialized institution"): |
| 2. | A corporation incorporated pursuant to the Civil Act or other statutes, which performs business affairs related to regulatory science or regulatory science innovation; |
| 3. | An institution supporting the planning, management, evaluation, etc. of national research and development programs among institutions established under other statutes. |
| (2) | The Minister of Food and Drug Safety may provide subsidies to cover expenses incurred by a specialized institution in performing business affairs on his or her behalf under Article 7(4) of the Act. |
| Article 19 (Payment, use, and management of contributions) |
| (1) | The Minister of Food and Drug Safety may pay contributions under Article 8(1) of the Act to research and development institutes in a lump sum or in installments, taking into consideration the scale of research tasks, timing for commencing research, financial conditions of the Government, etc. |
| (2) | A research and development institute in receipt of a contribution pursuant to Article 8(1) of the Act shall manage the contribution in a separate account, and shall keep evidential materials regarding the use of the contribution when it uses the contribution. |
CHAPTER IV TRAINING OF SPECIALIZED HUMAN RESOURCES IN REGULATORY SCIENCE
| Article 20 (Designation of institutions for training specialized human resources) |
| (1) | The standards for designating an institution for training specialized human resources under Article 15(1) of the Act (hereinafter referred to as "institution for training specialized human resources") shall be as follows: |
| 1. | It shall have education and training courses and curricula suitable for fostering human resources with expertise in systems, statutes, and regulations on food, drugs, etc., and technology and regulation, etc. of innovative products (hereinafter referred to as "specialized human resources"); |
| 2. | It shall secure human resources with expertise, such as faculty members specialized in the field of regulatory science or regulatory science innovation; |
| 3. | It shall have a track record of conducting education, surveys, research, consulting, etc. in the fields related to regulatory science or regulatory science innovation; |
| 4. | It shall be equipped with facilities and equipment publicly notified by the Minister of Food and Drug Safety as deemed necessary for training specialized human resources. |
| (2) | If the Minister of Food and Drug Safety intends to designate an institution for training specialized human resources, he or she shall publicly announce the period and method of applying for designation and other matters necessary for applying for designation on the website, etc. of the Ministry of Food and Drug Safety. |
| (3) | A person who intends to be designated as an institution for training specialized human resources shall submit to the Minister of Food and Drug Safety an application for designation prescribed by Prime Ministerial Decree, along with documents prescribed by Prime Ministerial Decree. |
| (4) | If the Minister of Food and Drug Safety in receipt of an application under paragraph (3) designates the relevant institution as an institution for training specialized human resources, he or she shall issue a certificate of designation, as prescribed by Prime Ministerial Decree, and post the fact on the website of the Ministry of Food and Drug Safety. |
| (5) | The standards for administrative dispositions on institutions for training specialized human resources under Article 15(3) of the Act shall be as specified in the Appendix. |
| (6) | Except as provided in paragraphs (1) through (5), details necessary for standards and procedures, etc. for designating institutions for training specialized human resources shall be determined and publicly notified by the Minister of Food and Drug Safety. |
CHAPTER V SUPPLEMENTARY PROVISIONS
| Article 21 (Delegation and entrustment of authority and business affairs) |
| (1) | The Minister of Food and Drug Safety shall delegate the following authority to the Director General of the National Institute of Food and Drug Safety Evaluation pursuant to Article 20 (1) of the Act: <Amended on Nov. 4, 2025> |
| 1. | Selection of research tasks by year or by field and conclusion of agreements under Article 7 (2) of the Act; provided, research and development projects for which the Minister of Food and Drug Safety provides contributions under Article 8 of the Act shall be excluded; |
| 2. | Authority to have a specialized agency perform the business affairs falling under the subparagraphs of that paragraph on his or her behalf under Article 7 (4) of the Act; provided, research and development projects for which the Minister of Food and Drug Safety pays contributions under Article 8 of the Act shall be excluded; |
| 3. | Deleted; <Nov. 4, 2025> |
| 4. | Deleted; <Nov. 4, 2025> |
| 5. | Promoting research and development programs as international cooperation programs under Article 18(1)1 of the Act. |
| (2) | Pursuant to Article 20(2) of the Act, the Minister of Food and Drug Safety may entrust the following business affairs to an institution or organization falling under any subparagraph of paragraph (3): |
| 1. | Support for commercialization under Article 13 of the Act; |
| 2. | Fact-finding surveys under Article 16 of the Act; |
| 3. | The promotion of international cooperation programs under Article 18 of the Act (excluding research and development programs under paragraph (1)1 of that Article). |
| (3) | "Institutions or organizations prescribed by Presidential Decree" in Article 20(2) of the Act means any of the following institutions, organizations, etc.: |
| 3. | A corporation incorporated pursuant to the Civil Act or other statutes, which performs business affairs related to regulatory science or regulatory science innovation; |
| 5. | Other institutions or organizations recognized by the Minister of Food and Drug Safety as having expertise in the business affairs related to regulatory science and regulatory science innovation. |
| (4) | If the Minister of Food and Drug Safety entrusts business affairs pursuant to Article 20(2) of the Act, he or she shall publicly notify the trustee and details of the entrusted business affairs. |
ADDENDA <Presidential Decree No. 34207, Feb. 6, 2024>
Article 1 (Enforcement date)
This Decree shall enter into force on February 17, 2024.
Article 2 (Transitional measures concerning commissioned members of the Committee)
Article 4 (Relationship to other statutes or regulations)
ADDENDA <Presidential Decree No. 35842, Nov. 4, 2025>
Article 1 (Enforcement date)
This Decree shall enter into force on the date of its promulgation.
Article 2 (Transitional measures concerning business delegation agreements)
Any business delegation agreement concluded between the Director General of the National Institute of Food and Drug Safety Evaluation and a specialized institution at the time of the enforcement of this Decree shall be deemed an agreement concluded between the Minister of Food and Drug Safety and the specialized institution, in accordance with the amended provisions of the proviso of Article 21 (1) 2.
ADDENDA <Presidential Decree No. 36055, Jan. 27, 2026>
Article 1 (Enforcement date)
This Decree shall enter into force on February 1, 2026.