CHAPTER I GENERAL PROVISIONS
The purpose of this Act is to contribute to enabling citizens to lead safe and healthy lives by reasonably managing the safety of foods, drugs, etc. based on regulatory science for the safe use of foods, drugs, etc. and the prompt commercialization thereof.
The terms used in this Act are defined as follows:
| 1. | The term “foods, drugs, etc.” means any of the following: |
| (a) | Foods, food additives, apparatus, containers and packages as defined in the Food Sanitation Act; |
| (f) | Drugs (excluding veterinary drugs), herbal medicines, herbal medication, and quasi-drugs (excluding veterinary quasi-drugs) as defined in the Pharmaceutical Affairs Act; |
| (i) | Medical devices as defined in the Medical Devices Act (excluding veterinary medical devices); |
| (j) | Hygiene products under the Hygiene Products Control Act; |
| (k) | Others prescribed by Presidential Decree, similar to those referred to in items (a) through (j); |
| 2. | The term "regulatory science for foods, drugs, etc." means science related to technologies, standards, and approaches in all aspects of safety management, ranging from the evaluation in terms of safety, efficacy, quality, performance, etc. of foods, drugs, etc. to authorization, permission, and use; |
| 3. | The term "regulatory science innovation" means a series of processes in which a reasonable regulatory foundation is created to ensure the safe use of foods, drugs, etc. and prompt commercialization thereof by promoting research and development programs under Article 7 and programs for training specialized human resources under Article 14 and by utilizing the outcomes therefrom in order to promote regulatory science for foods, drugs, etc. (hereinafter referred to as "regulatory science"). |
| Article 3 (Responsibilities of the State) |
The State shall endeavor to innovate regulatory science, constantly developing evaluation standards, methods, etc., training specialized human resources, providing support for commercialization from the initial stage of development so that foods, drugs, etc. are quickly commercialized for the safe use by citizens.
| Article 4 (Relationship to Other Statutes) |
Except as provided in other statutes, this Act shall apply to regulatory science and to regulatory science innovation.
CHAPTER II FORMULATION OF MASTER PLANS FOR REGULATORY SCIENCE INNOVATION
| Article 5 (Development of Master Plans for Regulatory Science Innovation) |
| (1) | The Minister of Food and Drug Safety shall formulate a five-year mater plan for regulatory science innovation (hereinafter referred to as “master plan”), in consultation with the heads of the related central administrative agencies. In such cases, the master plan shall undergo deliberation by the Regulatory Science Innovation Committee for Foods and Drugs under Article 6 and the Presidential Advisory Council on Science and Technology under the Presidential Advisory Council on Science and Technology Act. |
| (2) | A master plan shall include the following matters: |
| 1. | Direction and objectives of regulatory science innovation; |
| 2. | Analysis of domestic and global environments of regulatory science innovation; |
| 3. | Core strategies related to regulatory science innovation; |
| 4. | Matters related to securing and distributing financial resources for regulatory science innovation; |
| 5. | Matters related to promoting research and development programs under Article 7; |
| 6. | Matters related to support for the commercialization of innovative products (referring to foods, drugs, etc. utilizing new technology; hereinafter the same shall apply); |
| 7. | Matters related to training specialized human resources referred to in Article 14; |
| 8. | Other matters deemed by the Minister of Food and Drug Safety to be necessary for regulatory science innovation. |
| (3) | Where necessary for formulating a master plan, the Minister of Food and Drug Safety may request that the heads of relevant central administrative agencies, the heads of local governments, the heads of enterprises, educational institutions or research institutes, and the heads of institutions or organizations related to regulatory science innovation provide cooperation, such as submission of necessary data. |
| (4) | The Minister of Food and Drug Safety shall formulate and implement an annual action plan (hereinafter referred to as “action plan”) in compliance with a master plan. |
| (5) | Matters necessary for the formulation and implementation of a master plan and an action plan shall be prescribed by Presidential Decree. |
| Article 6 (Regulatory Science Innovation Committee for Foods and Drugs) |
| (1) | The Regulatory Science Innovation Committee for Foods and Drugs (hereinafter referred to as the “Committee”) shall be established under the jurisdiction of the Minister of Food and Drug Safety to deliberate on the following matters with regard to regulatory science innovation: |
| 1. | Matters related to a master plan and an action plan; |
| 2. | Matters related to the formulation and adjustment of major policies for regulatory science innovation; |
| 3. | Matters related to direction-setting for budget investment for regulatory science innovation; |
| 4. | Matters related to the promotion of research and development programs under Article 7, support for the commercialization of innovative products, and training of professional human resources under Article 14; |
| 5. | Matters related to the management of performance in regulatory science innovation; |
| 6. | Other matters related to regulatory science innovation submitted by the Minister of Drug and Safety for deliberation. |
| (2) | It shall be ensured that a majority of the total members of the Committee are comprised of experts with the extensive knowledge of and experience in regulatory science or regulatory science innovation, who are not public officials. |
| (3) | Other matters necessary for the organization, operation, etc. of the Committee shall be prescribed by Presidential Decree. |
CHAPTER III PROMOTION OF RESEARCH AND DEVELOPMENT PROGRAMS
| Article 7 (Promotion of Research and Development Programs) |
| (1) | The Minister of Food and Drug Safety shall conduct research and development programs necessary to reasonably manage the safety of foods, drugs, etc. (hereinafter referred to as "research and development program"), such as developing scientific grounds for new evaluation technologies, standards, methods, etc. necessary for the prompt commercialization of foods, drugs, etc. so that citizens can safely use them. |
| (2) | In implementing research and development programs, the Minister of Food and Drug Safety may select a research task by year and field and conclude an agreement with the following institutes, organizations, etc. (hereinafter referred to as “research and development institute”) to have them conduct research. In such cases, the Minister may enter into an agreement with the corporation with which an institute specified in subparagraph 5 is affiliated, if such institute is a non-corporate entity: |
| 1. | A national or public research institute; |
| 5. | A company-affiliated research institute that satisfies the requirements prescribed by Presidential Decree, in terms of research personnel and others; |
| 6. | A research institute that satisfies the requirements prescribed by Presidential Decree, in terms of research personnel and others, being a corporate research institute established pursuant to the Civil Act or other statutes; |
| 7. | Other research institutes or organizations specializing in the field of regulatory science for foods, drugs, etc., that satisfy the requirements prescribed by Presidential Decree, in terms of research personnel and others. |
| (3) | Expenses incurred in conducting research under paragraph (2) shall be covered by Government contributions, non-governmental contributions by research and development institutes, and technology development funds from corporations. |
| (4) | To efficiently implement research and development programs, the Minister of Food and Drug Safety may authorize an institution or organization prescribed by Presidential Decree (hereinafter referred to as “specialized institution”) to perform the following duties on his or her behalf: |
| 1. | Planning, management, and evaluation of research and development programs; |
| 2. | Entering into agreements on the research tasks under paragraph (2); |
| 3. | Dissemination of technology developed through research and development programs; |
| 4. | Other business affairs related to research and development, which are determined by the Minister of Food and Drug Safety to be handled by a specialized institution. |
| (5) | Matters regarding the methods for selecting research tasks and entering into agreements under paragraph (2) and other necessary matters shall be prescribed by Presidential Decree. |
| Article 8 (Financial Contributions) |
| (1) | The Minister of Food and Drug Safety may award financial contributions, within the budget, to research and development institutes to help them cover the expenses incurred in conducting research pursuant to Article 7 (2). |
| (2) | Matters necessary for the award, use, and management of the financial contributions referred to in paragraph (1) shall be prescribed by Presidential Decree. |
| Article 9 (Formulation of Classification System for Research and Development Programs) |
| (1) | The Minister of Food and Drug Safety shall prepare and manage a classification system to efficiently manage research and development programs and shall continuously supplement and develop such system. |
| (2) | Matters necessary for the preparation and management of the classification system referred to in paragraph (1) and other matters shall be prescribed by Ordinance of the Prime Minister. |
| Article 10 (Application Mutatis Mutandis of the National Research and Development Innovation Act) |
Except as provided in this Chapter, the relevant provisions of the National Research and Development Innovation Act and other statutes or regulations pertaining to national science and technology research and development programs shall apply, or apply mutatis mutandis, to matters regarding the implementation of research and development programs under Articles 7 through 9.
CHAPTER IV SUPPORT FOR COMMENCIALIZATION
| Article 11 (Support for Development and Disclosure of Evaluation Standards) |
| (1) | To enhance the effectiveness of the development of innovative products and support their prompt entry into the market, the Minister of Food and Drug Safety shall cooperate so that the evaluation standards developed through research and development programs can be adopted from the development stage of such innovative products. |
| (2) | The Minister of Food and Drug Safety may disclose to the public the standards for evaluation in terms of safety, efficacy, quality, etc. of innovative products, as prescribed by the Minister of Food and Drug Safety. |
| Article 12 (Examination of Regulatory Coherence) |
| (1) | For the development of an innovative product, the head of a central administrative agency who has promoted, or is expected to promote, a national research and development program under Article 2 of the National Research and Development Innovation Act may request that the Minister of Food and Drug Safety examine the following matters related to the safety, efficacy, quality, etc. of the relevant product (hereinafter referred to as "examination of regulatory coherence"): |
| 1. | Whether the product falls into the category of foods, drugs, etc., and applicable statutes or regulations; |
| 2. | Evaluation standards, methods, and requirements necessary for the development of an innovative product; |
| 3. | Whether it is necessary to implement a research and development program jointly with the Ministry of Food and Drug Safety; |
| 4. | Other matters the Minister of Food and Drug Safety deems necessary. |
| (2) | Upon receipt of a request for the examination of regulatory coherence under paragraph (1), the Minister of Food and Drug Safety shall conduct examination and inform the head of the central administrative agency who has made such request of the results thereof. |
| (3) | The Minister of Food and Drug Safety may request necessary data from the head of a relevant central administrative agency in relation to the examination of regulatory coherence, and the head of the relevant central administrative agency so requested shall cooperate, unless there is a compelling reason not to do so. |
| (4) | Details such as the standards, methods, and procedures for the examination of regulatory coherence shall be prescribed by Ordinance of the Prime Minister. |
| Article 13 (Support for Commercialization) |
| (1) | A person who intends to develop an innovative product (excluding the head of a central administrative agency under Article 12 (1)) may request that the Minister of Food and Drug Safety examine the following matters with respect to the safety, efficacy, quality, etc. of the relevant product: |
| 1. | Matters falling under Article 12 (1) 1, 2, and 4; |
| 2. | Whether any safety test, such as a clinical test, is required, the evaluation methods, and the procedures and requirements for necessary authorization, permission, etc. |
| (2) | Upon receipt of a request for examination under paragraph (1), the Minister of Food and Drug Safety shall conduct examination and inform the person who has made such request of the results thereof. |
| (3) | Where a person notified under paragraph (2) so desires, the Minister of Food and Drug Safety may provide administrative and technical support depending on the progress of product development. |
| (4) | Details regarding the eligibility, methods, and procedures for examination and support under paragraphs (1) through (3) shall be prescribed by Ordinance of the Prime Minister. |
CHAPTER V TRAINING OF SPECIALIZED HUMAN RESOURCES IN REGULATORY SCIENCE
| Article 14 (Formulation of Plans for Training Specialized Human Resources) |
| (1) | The Minister of Food and Drug Safety shall train human resources who have expertise in systems and statutes or regulations regarding foods, drugs, etc., and expertise in technologies and regulations for innovative products (hereinafter referred to as "specialized human resources") so as to support the development and commercialization of innovative products. |
| (2) | The Minister of Food and Drug Safety shall include the following matters in a master plan and an action plan for training specialized human resources: |
| 1. | Matters related to areas requiring training of specialized human resources and methods therefor; |
| 2. | Matters related to industry-academia-government cooperation for training specialized human resources; |
| 3. | Matters related to research, education, training, etc. for specialized human resources; |
| 4. | Other matters deemed by the Minister of Food and Drug Safety to be necessary for training specialized human resources. |
| (3) | The Minister of Food and Drug Safety may determine matters regarding qualifications of specialized human resources, their fields of activities, education, and training and may operate a licensing system, as prescribed by Ordinance of the Prime Minister. |
| Article 15 (Designation of Institutions for Training Specialized Human Resources) |
| (1) | The Minister of Food and Drug Safety may designate universities, research institutes, and other related institutions, equipped with appropriate human resources, facilities, etc., capable of providing education and training programs for specialized human resources, as institutions for training specialized human resources. |
| (2) | The Minister of Food and Drug Safety may, within the budget, fully or partially subsidize the expenses required for education and training provided by an institution for training specialized human resources designated under paragraph (1). |
| (3) | Where an institution for training specialized human resources designated in accordance with paragraph (1) falls under any of the following cases, necessary measures may be taken such as the revocation of designation, suspension of all or some of its business operations for up to one year, or an order for correction: Provided, That where subparagraph 1 is applicable, such designation shall be revoked and a hearing shall be held beforehand: |
| 1. | Where it was designated by fraud or other improper means; |
| 2. | Where it no longer meets the requirements for designation under paragraph (1); |
| 3. | Where it committed an illegal or wrongful act, such as violating any matter designated. |
| (4) | The standards and procedures for the designation of an institution for training specialized human resources pursuant to paragraph (1), and matters regarding such measures as the revocation of designation pursuant to paragraph (3) shall be prescribed by Presidential Decree. |
CHAPTER Ⅵ SUPPLEMENTARY PROVISIONS
| Article 16 (Fact-Finding Surveys) |
| (1) | For the purpose of regulatory science innovation, the Minister of Food and Drug Safety may conduct a fact-finding survey on market trends, authorization and permission systems, etc. at home and abroad, analyze the findings of the fact-finding survey, and disseminate them to related industries, academic circles, research institutes, etc. |
| (2) | The Minister of Food and Drug Safety may evaluate the following matters through the fact-finding survey, etc. prescribed in paragraph (1), and reflect the results thereof in the policies for regulatory science innovation: |
| 1. | Impact of regulatory science innovation on national health, industrial environment, etc.; |
| 2. | Levels of overseas and domestic infrastructure for regulatory science innovation. |
| (3) | Matters necessary for the details and scope of surveys and evaluation referred to in paragraphs (1) and (2), and the methods, procedures, etc. therefor shall be prescribed by Ordinance of the Prime Minister. |
| Article 17 (Facilitation of Private-Pubic Cooperation) |
The Minister of Food and Drug Safety may formulate and implement policies for facilitating exchanges, cooperation, and communication, such as the composition of a consultative body among academic circles, research institutes, industrial circles, and the Government and the conduct of joint research, for the purpose of regulatory science innovation.
| Article 18 (International Cooperation Projects) |
| (1) | The Minister of Food and Drug Safety may conduct the following projects in cooperation with foreign governments, related international organizations, foreign research and development institutions, organizations, etc. for regulatory science innovation. In such cases, the Minister of Food and Drug Safety may have domestic institutions and organizations related thereto participate in the relevant projects: |
| 1. | Establishment of an international joint commercialization support system for regulatory science, training of specialized human resources, and the promotion of research and development programs; |
| 2. | Sharing of information and technology related to regulatory science; |
| 3. | Other matters deemed by the Minister of Food and Drug Safety to be necessary for regulatory science. |
| (2) | The Minister of Food and Drug Safety may provide necessary support, within the budget, to domestic institutions, organizations, etc. that participate in any of the projects referred to in paragraph (1). |
| Article 19 (Cooperation between South and North Korea in Regulated Science) |
The Minister of Food and Drug Safety may formulate policies for facilitating inter-Korean cooperation and exchanges with respect to regulatory science, in consultation with the heads of the relevant central administrative agencies.
| Article 20 (Delegation and Entrustment of Authority) |
| (1) | Part of the authority bestowed on the Minister of Food and Drug Safety under this Act may be delegated to the heads of subordinate agencies. |
| (2) | All or part of the duties of the Minister of Food and Drug Safety under this Act, which fall under Articles 13 and 16 through 18, may be entrusted to the institutions or organizations prescribed by Presidential Decree, as prescribed by Presidential Decree. |
| Article 21 (Legal Fiction as Public Officials in Application of Penalty Provisions) |
| 1. | A member who is not a public official, from among the members of the Committee prescribed in Article 6 (1); |
| 2. | An executive officer or an employee of the institution or organization performing duties by proxy under Article 7 (4); |
| 2. | An executive officer or an employee of the institution or organization performing the duties entrusted by the Minister of Land, Infrastructure and Transport under Article 20 (2). |
ADDENDUM <Act No. 19694, Aug. 16, 2023>
Article 1 (Enforcement Date)
This Act shall enter into force six months after the date of its promulgation.
Article 2 (Transitional Measures regarding Master Plan and Action Plan)
Article 3 (Transitional Measures regarding the Food and Drug Safety Technology Committee)
Article 4 (Transitional Measures regarding Research and Development Programs on Safety Technology for Foods and Drugs)
Article 5 (Relationships to Other Statutes or Regulations)