ACT ON THE PROMOTION OF TECHNOLOGY FOR ENSURING THE SAFETY OF FOOD AND DRUGS
Act No. 13333, May 18, 2015
Amended by Act No. 15344, Jan. 16, 2018
Act No. 15941, Dec. 11, 2018
The purpose of this Act is to contribute to enabling citizens to lead safe and healthy lives by creating an environment for developing safety technology for food, drugs, etc., formulating a systematic promotion plan, and thereby efficiently implementing research and development programs on safety technology for food, drugs, etc.
The definitions of the terms used in this Act are as follows:
| 1. | The term “food, drugs, etc.” means any of the following: |
| (a) | Food, 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) | Things prescribed by Presidential Decree, similar to those referred to in items (a) through (i); |
| 2. | The term “safety technology for food, drugs, etc.” means any of the following technologies related to the duties conducted by the Minister of Food and Drug Safety with respect to the safety of food, drugs, etc.: |
| (a) | Technology related to regulating standards for food, drugs, etc., evaluating the safety and effectiveness, risk assessment, testing and analysis; |
| (b) | Technology related to the prevention of risks, the reduction of risk factors, and safety management of the entirety of process from production to consumption of food, drugs, etc.; |
| (c) | Other technology for ensuring the safety of food, drugs, etc. as necessary for maintaining life and improving health. |
| Article 3 (Responsibilities of the State) |
To enable citizens to lead safe and healthy lives, the State shall develop and implement comprehensive policies necessary to create an environment for developing safety technology for food, drugs, etc., and to promote such safety technology systematically.
| Article 4 (Relations to Other Acts) |
Except as otherwise expressly provided for in other Acts, safety technology for food, drugs, etc. shall be governed by the provisions of this Act.
| Article 5 (Master Plans for Promotion of Safety Technology for Food, Drugs, Etc.) |
| (1) | The Minister of Food and Drug Safety shall formulate a Mater Plan for the Promotion of Safety Technology for Food, Drugs, etc. (hereinafter referred to as “Master Plan”), in consultation with the heads of the related central administrative agencies every five years. In such cases, the Master Plan shall be deliberated by the Food and Drug Safety Technology Committee established under Article 6 and the Presidential Advisory Council on Science and Technology established pursuant to the Presidential Advisory Council on Science and Technology Act. <Amended by Act No. 15344, Jan. 16, 2018; Act No. 15941, Dec. 11, 2018> |
| (2) | The Master Plan shall contain the following: |
| 1. | The course of direction and objectives for developing safety technology for food, drugs, etc.; |
| 2. | Analysis of the domestic and international environment for developing safety technology for food, drugs, etc.; |
| 3. | Development strategies of critical and key safety technology for food, drugs, etc.; |
| 4. | Mid-to long-term investment strategies to promote safety technology for food, drugs, etc.; |
| 5. | Other matters deemed necessary by the Minister of Food and Drug Safety for promoting safety technology for food, drugs, etc. |
| (3) | The Minister of Food and Drug Safety shall formulate and implement an annual action plan (hereinafter referred to as “action plan”) in compliance with the relevant Master Plan. |
| (4) | Matters necessary for the formulation and implementation of Master Plans and action plans shall be prescribed by Presidential Decree. |
| Article 6 (Food and Drug Safety Technology Committee) |
| (1) | The Food and Drug Safety Technology Committee shall be established under the jurisdiction of the Minister of Food and Drug Safety to deliberate on the following matters regarding safety technology for food, drugs, etc.: |
| 1. | Matters regarding Master Plans and action plans; |
| 2. | Matters regarding formulation and adjustment of major policies to promote safety technology for food, drugs, etc.; |
| 3. | Matters regarding evaluation of research and development programs on safety technology for food, drugs, etc.; |
| 4. | Matters regarding direction-setting for investment of budgets for safety technology for food, drugs, etc.; |
| 5. | Matters regarding performance management of safety technology for food, drugs, etc.; |
| 6. | Other matters regarding safety technology for food, drugs, etc., which are referred by the Minister of Food and Drug Safety for deliberation. |
| (2) | Matters necessary for the organization, operation, etc. of the Food and Drug Safety Technology Committee shall be prescribed by Presidential Decree. |
[This Article Wholly Amended by Act No. 15941, Dec. 11, 2018]
| Article 7 (Implementation of Research and Development Programs) |
| (1) | The Minister of Food and Drug Safety shall implement research and development programs on safety technology for food, drugs, etc. (hereinafter referred to as “research and development programs”) to efficiently promote Master Plans and action plans. |
| (2) | To implement research and development programs, the Minister of Food and Drug Safety shall select annual research tasks for each field and enter into an agreement with any of the following research institutes, organizations, etc. (hereinafter referred to as “research institute”) to authorize the research institute to conduct research. In such cases, the Minister may enter into an agreement with the representative of a corporation with which a research institute stipulated in subparagraph 5 is affiliated, if such research 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, including research personnel; |
| 6. | A research institute that satisfies the requirements prescribed by Presidential Decree, including research personnel, being a corporate research institute established pursuant to the Civil Act and other Acts; |
| 7. | Other research institutes or organizations specializing in the field of safety technology for food, drugs, etc., that satisfy the requirements prescribed by Presidential Decree, including research personnel. |
| (3) | Expenses incurred in conducting research under paragraph (2) shall be covered by Government contributions, non-governmental contributions, and technology development funds of companies. |
| (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/her behalf: |
| 1. | Planning, management, and evaluation of research and development programs; |
| 2. | Entering into agreements on the research tasks selected under paragraph (2); |
| 3. | Dissemination of technology developed through research and development programs; |
| 4. | Other duties related to promoting safety technology for food, drugs, etc., that the Minister of Food and Drug Safety determines, to be performed by specialized institutions on his/her behalf. |
| (5) | Methods of selecting research tasks and methods of entering into agreements under paragraph (2) and other necessary matters shall be stipulated by Presidential Decree. |
| Article 7-2 (Restrictions on Participation in Research and Development Programs) |
The Minister of Food and Drug Safety may restrict participation of research institutes, principal researchers, researchers, or affiliated executive officers and employees who have participated in research and development programs prescribed in Article 7 pursuant to Article 11-2 of the Framework Act on Science and Technology or may recover the whole or part of the contributions or subsidies already provided to cover their business expenses. [This Article Newly Inserted by Act No. 15941, Dec. 11, 2018]
| Article 8 (Financial Contributions) |
| (1) | The Minister of Food and Drug Safety may award financial contributions to research institutes, within budgetary limits, to 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 stipulated by Presidential Decree. |
| Article 9 (Accelerating Transfer of Research and Development Outcomes) |
The Minister of Food and Drug Safety shall establish policies to promptly transfer the outcomes of research and development programs to enterprises for commercialization or to make such outcomes available for industries.
| Article 10 (Collection of Royalties) |
| (1) | The Minister of Food and Drug Safety may collect royalties from any person(s) who intends to use, transfer, lease, or export the outcomes of research and development programs implemented under Article 7 (2), as stipulated by Presidential Decree: Provided, That any national or public research institute(s) or any institution(s) prescribed by Presidential Decree may be granted partial or full exemption from the payment of royalties if it intends to use the outcomes of any research and development program(s) for public interest or in circumstances prescribed by Presidential Decree. |
| (2) | The collection and management of the royalties referred to in paragraph (1), and other necessary matters shall be stipulated by Presidential Decree. |
| Article 11 (Establishment of Classification System of Safety Technology for Food, Drugs, Etc.) |
| (1) | The Minister of Food and Drug Safety shall establish and manage a classification system of safety technology for food, drugs, etc. and consistently cure and develop the classification system to effectively manage information, human resources, and research and development programs related to safety technology for food, drugs, etc. |
| (2) | The establishment and management of the classification system referred to in paragraph (1) and other necessary matters shall be stipulated by Ordinance of the Prime Minister. |
| Article 12 (Survey of Demand for Safety Technology for Food, Drugs, Etc.) |
| (1) | The Minister of Food and Drug Safety may survey demand for safety technology for food, drugs, etc. that the industries require throughout the entire process from production to consumption of food, drugs, etc. to identify, develop, and disseminate safety technology for food, drugs, etc. |
| (2) | The subject-matter of the survey for demand under paragraph (1), methods of, and procedures for, conducting such survey, and other necessary matters shall be stipulated by Ordinance of the Prime Minister. |
| Article 13 (Examination of Capacities, etc. to Develop Technology) |
| (1) | Any institution, organization, and enterprise related to developing safety technology for food, drugs, etc. may request the Minister of Food and Drug Safety to examine its capacities and systems to develop such safety technology (hereinafter referred to as “capacities, etc. to develop technology”). |
| (2) | Upon receipt of a request under paragraph (1), the Minister of Food and Drug Safety may examine the capacities, etc. to develop technology and if necessary, implement a support program to improve such capacities, etc. |
| (3) | Requests for the examination of the capacities, etc. to develop technology under paragraphs (1) and (2), methods of, and procedures for, conducting such examinations, and other necessary matters shall be stipulated by Ordinance of the Prime Minister. |
| Article 14 (Technology Impact Assessment and Technology Evaluation) |
| (1) | The Minister of Food and Drug Safety may preliminarily assess the impacts of safety technology for food, drugs, etc. he/she intends to develop through a research and development program on national health, industrial environments, etc., and reflect the findings from such preliminary assessment in technological development policies. |
| (2) | The Minister of Food and Drug Safety shall evaluate technologies that constitute critical and key safety technology for food, drugs, etc. at the domestic and international level, and formulate and implement policies to improve such technologies. |
| (3) | The scope of a preliminary technology impact assessment under paragraph (1) and the evaluation of technologies under paragraph (2), procedures for conducting a preliminary technology impact assessment and technology evaluation, and other necessary matters shall be stipulated by Presidential Decree. |
| Article 15 (Collaborative Projects, such as International Joint Research) |
| (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. to develop safety technology for food, drugs, etc., and promote related technology. In such cases, the Minister of Food and Drug Safety may permit Korean research and development institutions, organization, etc. to jointly participate in such projects: |
| 1. | International joint research on safety technology for food, drugs, etc.; |
| 2. | Exchanges of safety technology for food, drugs, etc. and information thereon; |
| 3. | Other matters the Minister of Food and Drug Safety deems necessary to promote safety technology for food, drugs, etc. |
| (2) | The Minister of Food and Drug Safety may provide necessary assistance to Korean research and development institutions, organizations, etc. that participate in any of the projects referred to in paragraph (1), within budgetary limits. |
| Article 16 (Inter-Korean Cooperation, etc. on Safety Technology for Food, Drugs, Etc.) |
The Minister of Food and Drug Safety may establish policies to encourage inter-Korean cooperation and exchanges with respect to safety technology for food, drugs, etc., in consultation with the heads of the related central administrative agencies.
| Article 17 (Delegation or Entrustment of Authority) |
| (1) | As stipulated by Presidential Decree, the authority bestowed on the Minister of Food and Drug Safety under this Act may be partially delegated to the heads of subordinate agencies. |
| (2) | As stipulated by Presidential Decree, the duties of the Minister of Food and Drug Safety under this Act may be partially entrusted to an institution or organization prescribed by Presidential Decree. |
| Article 18 (Persons Deemed Public Officials for Purposes of Penalty Provisions) |
Any executive officer or employee of a specialized institution that performs the duties of the Minister of Food and Drug Safety on his/her behalf pursuant to Article 7 (4), or of an institution or organization that performs the duties entrusted by the Minister of Food and Drug Safety pursuant to Article 17 (2), shall be deemed a public official for the purposes of the penalty provisions under Articles 129 through 132 of the Criminal Act.
ADDENDUM
This Act shall enter into force six months after the date of its promulgation.
ADDENDA <Act No. 15344, Jan. 16, 2018>
Article 1 (Enforcement Date)
This Act enters into force three months after the date of its promulgation.
Articles 2 through 4 Omitted.
ADDENDUM <Act No. 15941, Dec. 11, 2018>
This Act shall enter into force six months after the date of its promulgation.