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ACT ON THE PROMOTION OF TECHNOLOGY FOR ENSURING THE SAFETY OF FOOD, DRUGS, ETC.

Act No. 13333, May 18, 2015

Amended by Act No. 15344, Jan. 16, 2018

 Article 1 (Purpose)
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.
 Article 2 (Definitions)
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;
(b) Agricultural and fishery products and processed agricultural and fishery products as defined in the Agricultural and Fishery Products Quality Control Act;
(c) Livestock products as defined in the Livestock Products Sanitary Control Act;
(d) Alcoholic beverages as defined in the Liquor Tax Act;
(e) Health functional foods as defined in the Health Functional Foods Act;
(f) Drugs (excluding veterinary drugs), herbal medicines, herbal medication, and quasi-drugs (excluding veterinary quasi-drugs) as defined in the Pharmaceutical Affairs Act;
(g) Narcotics as defined in the Narcotics Control Act;
(h) Cosmetics as defined in the Cosmetics 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 develop a Mater Plan for the Promotion of Safety Technology for Food, Drugs, etc. (hereinafter referred to as “Master Plan”), on a five-year basis, in consultation with the heads of the related central administrative agencies. In such cases, the Master Plan shall be deliberated by 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>
(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 the Minister of Food and Drug Safety deems necessary to promote safety technology for food, drugs, etc.
(3) The Minister of Food and Drug Safety shall develop and implement an annual action plan (hereinafter referred to as “action plan”) in compliance with the relevant Master Plan.
(4) Matters necessary for the development and implementation of Master Plan(s) and action plan(s) shall be prescribed by Presidential Decree.
 Article 6 (Consultations on Safety Technology for Food, Drugs, Etc.)
(1) The Minister of Food and Drug Safety may, if necessary, consult with external experts, etc. to decide matters related to the promotion of safety technology for food, drugs, etc.
(2) Procedures for consultations under paragraph (1), payment of consulting fees, and other matters necessary for consultations on safety technology for food, drugs, etc. shall be stipulated by Ordinance of the Prime Minister.
 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 Plan(s) and action plan(s).
(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;
2. A specific research institute as defined in Article 2 of the Specific Research Institutes Support Act;
3. A Government-funded research institute established pursuant to the Act on the Establishment, Operation and Fostering of Government-Funded Research Institutes, Etc. or a Government-funded science and technology research institute established pursuant to the Act on the Establishment, Operation and Fostering of Government-Funded Science and Technology Research Institutes, Etc.;
4. A school as defined in the Higher Education Act;
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 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.