ENFORCEMENT DECREE OF THE BIOTECHNOLOGY SUPPORT ACT
Presidential Decree No. 14731, Jul. 13, 1995
Amended by Presidential Decree No. 16326, May 24, 1999
Presidential Decree No. 17048, Dec. 29, 2000
Presidential Decree No. 17115, Jan. 29, 2001
Presidential Decree No. 18452, Jun. 29, 2004
Presidential Decree No. 20740, Feb. 29, 2008
Presidential Decree No. 22075, Mar. 15, 2010
Presidential Decree No. 24423, Mar. 23, 2013
Presidential Decree No. 25751, Nov. 19, 2014
Presidential Decree No. 28210, Jul. 26, 2017
Presidential Decree No. 31168, Nov. 20, 2020
Presidential Decree No. 31380, Jan. 5, 2021
Presidential Decree No. 32532, Mar. 15, 2022
Presidential Decree No. 35455, Apr. 22, 2025
CHAPTER I GENERAL PROVISIONS
The purpose of this Decree is to prescribe matters mandated by the Biotechnology Support Act and those necessary for the enforcement thereof. <Amended on Jul. 13, 1995; Nov. 20, 2020>
| Article 1-2 Deleted. <Mar. 15, 2022> |
CHAPTER II PLANNING AND IMPLEMENTATION SYSTEM FOR BIOTECHNOLOGY SUPPORT
| Article 2 (Formulation of master plans for biotechnology development) |
| (1) | The Minister of Science and ICT shall formulate a master plan for biotechnology development under Article 5 (2) of the Act (hereinafter referred to as "master plan") every 5 years and shall notify the heads of the relevant central administrative agencies of such plan. |
| (2) | Where necessary to formulate a master plan, the Minister of Science and ICT may request the heads of relevant central administrative agencies, the heads of local governments, the heads of relevant educational or research institutes, or enterprises having participated in a national research and development program under Article 11 of the Framework Act on Science and Technology (hereinafter referred to as "national research and development program") to submit necessary materials. |
[This Article Wholly Amended on Nov. 20, 2020]
| Article 3 (Formulation of annual implementation plans) |
| (1) | Each annual implementation plan under Article 6 (1) of the Act (hereinafter referred to as "implementation plan") shall include the following matters: |
| 1. | Outline of biotechnology-related projects (hereafter in this paragraph referred to as "projects"); |
| 2. | Performance of the projects for the previous year and project plans for the relevant year; |
| 3. | Detailed plan for each project; |
| 4. | Other matters that the Minister of Science and ICT deems necessary to be included in an implementation plan in order to promote technology development and industrialization in biotechnology. |
| (2) | The head of a relevant central administrative agency shall formulate an implementation plan by January 31 of each year and shall submit it to the Biotechnology Comprehensive Policy Council under Article 7 (1) of the Act (hereinafter referred to as the "Council"). |
| (3) | An implementation plan submitted under paragraph (2) shall be finalized after deliberation by the Council. |
| (4) | The Minister of Science and ICT shall notify the head of the relevant central administrative agency of the implementation plan finalized under paragraph (3). |
[This Article Wholly Amended on Nov. 20, 2020]
| Article 4 (Preparation of basic guidelines necessary for formulating implementation plans) |
Where the Minister of Science and ICT prepares basic guidelines necessary for formulating implementation plans pursuant to Article 6 (3) of the Act, he or she shall undergo deliberation by the Council.
[This Article Wholly Amended on Nov. 20, 2020]
| Article 5 (Composition of Council) |
| (1) | Deleted. <Jun. 29, 2004> |
| (2) | "Vice-ministerial level public officials of the relevant central administrative agencies who are prescribed by Presidential Decree" in Article 7 (4) 1 of the Act means the Vice Ministers of the following central administrative agencies; in such cases, where there are more than one Vice Minister in an agency, it shall be the one designated by the head of the relevant agency: <Amended on Jun. 29, 2004; Feb. 29, 2008; Mar. 15, 2010; Mar. 23, 2013; Nov. 19, 2014; Jul. 26, 2017; Nov. 20, 2020> |
| 1. | The Ministry of Economy and Finance; |
| 2. | The Ministry of Education; |
| 3. | The Ministry of Science and ICT; |
| 4. | The Ministry of Agriculture, Food and Rural Affairs; |
| 5. | The Ministry of Trade, Industry and Energy; |
| 6. | The Ministry of Health and Welfare; |
| 7. | The Ministry of Environment; |
| 8. | The Ministry of Oceans and Fisheries. |
| (3) | The members provided in Article 7 (4) 2 of the Act shall be commissioned by the Minister of Science and ICT with consideration for gender equality; and the term of office of the commissioned members shall be 2 years. <Amended on Jun. 29, 2004; Feb. 29, 2008; Mar. 23, 2013; Jul. 26, 2017; Nov. 20, 2020> |
[Title Amended on Jun. 29, 2004]
| Article 6 (Duties of chairperson of the Council) |
| (1) | The chairperson of the Council shall exercise general supervision over its affairs and shall convene and preside over meetings of the Council. <Amended on Nov. 20, 2020; Jan. 5, 2021> |
| (2) | Where the chairperson of the Council is unable to perform his or her duties due to any unavoidable reason, a member of the Council designated by the chairperson shall act on behalf of the chairperson. <Amended on Nov. 20, 2020> |
| (1) | Meetings of the Council shall be divided into regular and extraordinary meetings. |
| (2) | Regular meetings shall be convened once a year on a day set by the Council, and extraordinary meetings shall be convened by the chairperson of the Council as the occasion arises. <Amended on Nov. 20, 2020> |
| (3) | A majority of the members of the Committee shall constitute a quorum, and any decision thereof shall require the concurring vote of at least a majority of those present. |
| Article 8 (Executive secretary) |
| (1) | The Council shall have 1 executive secretary to handle general affairs of the Council. |
| (2) | The Minister of Science and ICT shall appoint 1 executive secretary from among public officials under his or her jurisdiction. <Amended on Jun. 29, 2004; Feb. 29, 2008; Mar. 23, 2013; Jul. 26, 2017> |
| Article 9 (Composition of working committee) |
| (1) | A working committee that may be established in the Council under Article 7 (5) of the Act (hereinafter referred to as the "working committee") shall be comprised of not more than 20 members, including 1 chairperson. |
| (2) | The First Vice Minister of Science and ICT shall serve as the chairperson of the working committee. |
| (3) | Members of the working committee shall be appointed or commissioned by the Minister of Science and ICT from among the following persons; in such cases, members falling under subparagraph 2 shall be commissioned with consideration for gender equality: |
| 1. | One public official designated by the head of each relevant central administrative agency specified in the subparagraphs of Article 5 (2) from among the members of the Senior Executive Service of the relevant central administrative agency; |
| 2. | Persons with extensive expertise and experience in promoting biotechnology and promoting technology development and industrialization in biotechnology, who engage in academia, research institutes, medical institutions, or industry. |
| (4) | The term of office of a member who is not a public official among the members commissioned under paragraph (3) shall be 2 years. |
[This Article Added on Nov. 20, 2020]
| Article 9-2 (Operation of working committee) |
| (1) | The working committee shall perform the following tasks under Article 7 (5) of the Act: |
| 1. | Prior review of matters to be deliberated upon under Article 7 (2) of the Act; |
| 2. | Tasks delegated by the Council; |
| 3. | Matters regarding biotechnology development and industrialization promotion that require coordination of opinions among relevant central administrative agencies; |
| 4. | Other matters regarding biotechnology development and industrialization promotion that the chairperson of the working committee deems necessary to be reviewed. |
| (2) | The working committee may establish subject-matter subcommittees, if necessary, in order to effectively conduct the working committee's reviews. |
| (3) | Matters necessary for the composition and operation of subcommittees under paragraph (2) shall be determined by the chairperson of the working committee after resolution by the working committee. |
| (4) | Except as provided in paragraphs (1) through (3), Articles 6 through 8 shall apply mutatis mutandis to the operation of the working committee. In such cases, the "Council" shall be deemed to be the "working committee". |
[This Article Added on Nov. 20, 2020]
| Article 10 (Hearing of opinions) |
The Council or the working committee may, if deemed necessary, require any relevant public official or expert with professional knowledge of and experience in biotechnology to attend a meeting of the Council or the working committee in order to hear their opinions. <Amended on Jul. 13, 1995; Jun. 29, 2004; Nov. 20, 2020>
Allowances or actual expenses may be paid within the budget to members, relevant public officials, or relevant experts who attend a meeting of the Council or the working committee; provided, no payment shall be made to a member who is a public official, or a relevant public official, if he or she attends a meeting in direct connection with his or her duties. <Amended on Jun. 29, 2004; Nov. 20, 2020>
| Article 11-2 (Content and scope of detailed policy measures for biotechnology development) |
Where the head of a relevant central administrative agency devises detailed policy measures for each field under his or her jurisdiction under Article 8 (3) of the Act (hereinafter referred to as "detailed policy measures"), he or she shall comply with the content and scope as classified in the following:
| 1. | Where each of the heads of the following relevant central administrative agencies devises detailed policy measures, the content and scope specified in the following classifications: |
| (a) | The Minister of Education: Policy measures to foster professional workforce and to support basic research in the field of biotechnology, which have been consulted with the Minister of Science and ICT; |
| (b) | The Minister of Science and ICT: Policy measures to formulate master plans, to comprehensively coordinate policies by agency, to assist the development of basic and original research and advanced technologies related to biotechnology, to support the research and development using information and communications technology, and to foster and develop biotechnology-related research institutes; |
| (c) | The Minister of Agriculture, Food and Rural Affairs: Policy measures to support applied research and industrialization in the fields of agriculture, livestock, and food, such as the breeding of, and improvement of varieties of, animals, plants, and microorganisms and the development of food materials; |
| (d) | The Minister of Trade, Industry and Energy: Policy measures to support technology development and to promote the industrialization thereof, including the development and improvement of biotechnology-related production technologies and industrial processes and the development and utilization of new and renewable energies; |
| (e) | The Minister of Health and Welfare: Policy measures to support applied and clinical research and advanced medical technology development and industrialization in the field of biotechnology related to health and medical services; |
| (f) | The Minister of the Environment: Policy measures to support applied research and industrialization in the field of environment, including conservation of biodiversity, sustainable uses of its components, treatment of wastewater and wastes using biotechnology, and prevention of environmental pollution; |
| (g) | The Minister of Oceans and Fisheries: Policy measures to support applied research and industrialization in the field of marine and fisheries, including the production of useful substances using marine and aquatic organisms, breeding and improvement of marine aquatic organisms, development of food materials, and development of marine pollution prevention technologies; |
| 2. | Where the head of any other relevant central administrative agency devises detailed policy measures, the content and scope determined in prior consultation with the Minister of Science and ICT. |
[This Article Added on Nov. 20, 2020]
| Article 11-3 (Procedures and methods for fact-finding surveys) |
| (1) | Where the head of a relevant central administrative agency intends to conduct a fact-finding survey pursuant to Article 9 (1) of the Act, he or she shall prepare a fact-finding survey plan including the objectives, subject matter, period, etc. of the survey and shall notify a person subject to the fact-finding survey in writing in advance. |
| (2) | A fact-finding survey under Article 9 (1) of the Act shall be conducted by means of on-site surveys, written surveys, statistical surveys, literature surveys, etc. and may be conducted using information and communications networks or electronic methods, such as e-mail, if necessary to efficiently conduct such survey. |
[This Article Added on Nov. 20, 2020]
| Article 11-4 (Procedures for technology impact assessment) |
| (1) | The specific target of the technology impact assessment under Article 10 (1) of the Act (hereinafter referred to as "technology impact assessment") shall be a technology determined by the Minister of Science and ICT in consultation with the heads of the relevant central administrative agencies, among new biotechnologies with a significant impact and ripple effect on the economy, society, culture, ethics, environment, etc. (hereafter in this Article referred to as "technology subject to assessment"). |
| (2) | The Minister of Science and ICT may request the heads of the relevant central administrative agencies and the heads of local governments to submit related materials, if necessary for the technology impact assessment. |
| (3) | The results of the technology impact assessment shall include each of the following matters: |
| 1. | The impact of the technology subject to assessment on the enhancement of the convenience of people's lives and the development of biotechnology-related industries; |
| 2. | The impact of the new biotechnology on the economy, society, culture, ethics, environment, etc.; |
| 3. | Other matters deemed necessary by the Minister of Science and ICT to be included in the results of the technology impact assessment. |
| (4) | The technology impact assessment shall be finalized after deliberation by the Council. |
| (5) | The Minister of Science and ICT shall notify the heads of relevant central administrative agencies of the results of the technology impact assessment finalized under paragraph (4). |
[This Article Added on Nov. 20, 2020]
CHAPTER III PROMOTION OF RESEARCH AND DEVELOPMENT OF BIOTECHNOLOGY
| Article 11-5 (Designation of promising biotechnologies) |
| (1) | Where necessary to designate promising biotechnologies under Article 11-2 (1) of the Act, the Minister of Science and ICT shall conduct demand surveys for other relevant central administrative agencies, local governments, enterprises, universities, research institutes, medical institutions, and biotechnology-related entities and organizations. |
| (2) | The heads of relevant central administrative agencies, the heads of research and development institutes under subparagraph 3 of Article 2 of the National Research and Development Innovation Act, and the heads of medical institutions may request the Minister of Science and ICT to designate promising biotechnologies. |
| (3) | A person who intends to request the designation of a promising biotechnology in accordance with paragraph (2) shall submit to the Minister of Science and ICT the following materials: |
| 1. | Scope and content of the technology for which the designation is requested; |
| 2. | Grounds for requesting the designation; |
| 3. | Materials related to Article 11-2 (2) 1 through 4 of the Act; |
| 4. | Opinions of experts from industry, academia, research circles, etc. related to the technology for which the designation is requested; |
| 5. | Other reference materials regarding the technology for which the designation is requested. |
| (4) | The Minister of Science and ICT may provide support for the following matters within the budget for promising biotechnologies designated under Article 11-2 (1) of the Act: |
| 1. | Research and development of promising biotechnologies and follow-up research and development to promote commercialization of research and development outcomes; |
| 2. | Production of prototypes to verify the effectiveness of technological development; |
| 3. | Demonstration related to promising biotechnologies; |
| 4. | Obtainment of authorization, permission, approval, etc. under applicable statutes and regulations; |
| 5. | Establishment and development of public sector markets for promising biotechnology-related products and services; |
| 6. | Consultation, technology assessment, and technology transactions to promote the transfer and commercialization of promising biotechnologies; |
| 7. | Dissemination activities and public outreach to increase social acceptance of promising biotechnologies; |
| 8. | Other matters for which the Minister of Science and ICT determines support is necessary for the development and commercialization of promising biotechnologies. |
| (5) | The head of a relevant central administrative agency, the head of a research and development institute defined in subparagraph 3 of Article 2 of the National Research and Development Innovation Act, and the head of a medical institution may request the Minister of Science and ICT to change or revoke the designation of a promising biotechnology under Article 11-2 (3) of the Act if they recognize that it is necessary to change or revoke the designation of the promising biotechnology already designated due to changes in the technological environment, such as the emergence of advanced technologies or the widespread use of promising technologies. |
| (6) | A person who requests to change or revoke the designation of a promising biotechnology under paragraph (5) shall submit to the Minister of Science and ICT the following materials: |
| 1. | Scope and content of the promising biotechnology in question; |
| 2. | Grounds for requesting change or revocation of designation; |
| 3. | Other reference materials regarding the request for change or revocation of designation of the promising biotechnology. |
| (7) | Upon receipt of a request under paragraph (2) or (5), the Minister of Science and ICT may designate a promising biotechnology or change or revoke the designation of the promising biotechnology after hearing opinions of relevant experts and reviewing the feasibility of the request, and after deliberation by the Council under Article 11-2 of the Act. |
[This Article added on April 22, 2025]
| Article 12 (Promotion of joint or convergence research) |
| (1) | Deleted. <Apr. 22, 2025> |
| (2) | The Government may conduct a demand survey to identify business fields in need of joint or convergence research in order to promote joint or convergence research under Article 12 (1) and (2) of the Act. <Amended on Apr. 22, 2025> |
| (3) | The Minister of Science and ICT may preferentially promote research and development programs related to the business fields identified as a result of the demand survey under paragraph (2), and, if necessary, request the heads of the relevant central administrative agencies to preferentially promote research and development programs related to the identified business fields. |
| (4) | The Minister of Science and ICT may recommend joint purchase of research equipment and reagents necessary for joint or convergence research, joint utilization of research facilities, etc. in order to promote joint or convergence research among academia, research institutes, medical institutions, and industry; and may provide necessary support. |
[This Article Wholly Amended on Nov. 20, 2020]
| Article 12-2 (Promotion of international cooperation) |
"Matters prescribed by Presidential Decree" in Article 13 (2) 6 of the Act means the following projects:
| 1. | Support for cross-border regulatory harmonization and international certification in biotechnology; |
| 2. | Collaboration to share, standardize, and interoperate biotechnology-related data; |
| 3. | Holding international exhibitions and international academic conferences to promote technical exchange and strengthen cooperation system on biotechnology; |
| 4. | Other projects deemed necessary to improve the level of biotechnology and promote exchanges; |
[This Article added on April 22, 2025]
[Previous Article 12-2 moved to Article 12-3 <Apr. 22, 2025>]
| Article 12-3 (Preparation of experimental guidelines) |
| (1) | The Minister of Health and Welfare shall prepare and implement experimental guidelines for the promotion of biotechnology research and industrialization under Article 14 of the Act after deliberation by the Council. <Amended on Dec. 23, 1994; Jul. 13, 1995; Feb. 29, 2008; Mar. 15, 2010; Nov. 20, 2020> |
| (2) | The experimental guidelines referred to in paragraph (1) shall include the following matters: <Amended on Jul. 13, 1995> |
| 1. | Matters necessary to prevent biological risks such as the method of inhibiting the prevention of dissemination and increase of genetically modified organisms; |
| 2. | Matters necessary to prevent the occurrence of ethical problems such as the prohibition of genetic modification of human genes, etc. which may cause effects detrimental to the dignity of human beings. |
[Moved from Article 12-2 <Apr. 22, 2025>]
CHAPTER IV PROMOTION OF BIOTECHNOLOGY INDUSTRIALIZATION
| Article 13 (Support for production of new technology products) |
| (1) | The Minister of Science and ICT may request the head of a relevant central administrative agency, after deliberation by the Council, to take necessary measures, such as providing funds and prioritizing the purchase of products in the fields under his or her jurisdiction in order to support the promotion of production and sales of new technology products related to biotechnology under Article 15 (1) 7 of the Act. <Amended on Jul. 13, 1995; Jun. 29, 2004; Feb. 29, 2008; Mar. 23, 2013; Jul. 26, 2017; Nov. 20, 2020; Apr. 22, 2025> |
| (2) | The head of the relevant central administrative agency in receipt of a request under paragraph (1) shall take necessary measures, such as providing funds and prioritizing the purchase of products, unless there is a compelling reason not to do so. <Amended on Nov. 20, 2020> |
| (3) | "Matters prescribed by Presidential Decree" in Article 15 (2) 3 of the Act means the following matters: <Added on Apr. 22, 2025> |
| 1. | Identify and forter prospective entrepreneurs; |
| 2. | Support for the commercialization or market development of business starters' outstanding ideas; |
| 3. | Support for prospective entrepreneurs or business starters to expand into overseas markets; |
| 4. | Support for domestic and overseas marketing and public relations activities; |
| 5. | Support for building networks to attract foreign investment; |
| 6. | Any other support deemed necessary to promonte biotechnology-related commercialization. |
| Article 14 (Preparation of guidelines for clinical trials and testing) |
| (1) | The Minister of Agriculture, Food and Rural Affairs, the Minister of Trade, Industry and Energy, the Minister of Health and Welfare, the Minister of Environment, and the Minister of Oceans and Fisheries shall establish a clinical trials and testing system for biotechnology-related products in the fields under their jurisdictions in accordance with Article 17 of the Act and prepare and implement guidelines for clinical trials and testing after deliberation by the Council; provided, the foregoing shall not apply where it is otherwise prescribed in any other statute or regulation. <Amended on Mar. 6, 1993; Dec. 23, 1994; Jul. 13, 1995; Jun. 29, 2004; Feb. 29, 2008; Mar. 15, 2010; Mar. 23, 2013; Nov. 20, 2020> |
| (2) | The guidelines for clinical trials and testing under paragraph (1) shall include the following matters; provided, if there are matters that cannot be prescribed in such guidelines due to the special nature of biotechnology-related products, such matters need not be prescribed in the guidelines: <Amended on Jul. 13, 1995; Nov. 20, 2020> |
| 1. | Animal testing of products produced or manufactured with genetically modified organisms; |
| 2. | Clinical trials of pharmaceutical products produced or manufactured with genetically modified organisms; |
| 3. | Analysis of ingredients, purity, activity, etc. of products produced or manufactured with genetically modified organisms; |
| 4. | Other matters necessary for clinical trials and testing of biotechnology-related products. |
CHAPTER V LAYING FOUNDATIONS FOR BIOTECHNOLOGY
| Article 14-2 (Training of professional workforce) |
"Projects prescribed by Presidential Decree" in Article 18 (3) 4 of the Act means the following projects:
| 1. | Training of professional workforce necessary for biotechnology research and development, automation and quality control of production process, etc.; |
| 2. | Training of professional workforce in the convergence of medicine and biotechnology; |
| 3. | Other professional workforce training projects deemed necessary for technology development and industrialization in biotechnology. |
[This Article added on April 22, 2025]
| Article 15 (Collection, management, and utilization of biotechnology information) |
| (1) | The Minister of Science and ICT may establish and operate an integrated management system for biotechnology-related information for the systematic management and utilization of biotechnology information under Article 19 (1) of the Act. |
| (2) | The scope of biotechnology information under Article 19 (2) of the Act shall be as follows: |
| 1. | Information related to domestic and foreign technology, policies, industries, and systems in the field of biotechnology; |
| 2. | Information related to domestic and international academic journals, research papers, and patents in the field of biotechnology; |
| 3. | Information on projects and research results related to national research and development programs in the field of biotechnology; |
| 4. | Information on research and development workforce, facilities, and equipment in the field of biotechnology; |
| 5. | Information on technology transfer and commercialization and technology start-up in the field of biotechnology; |
| 6. | Other information in the field of biotechnology recognized by the Minister of Science and ICT as requiring collection, management, utilization in order to invigorate biotechnology research and development and promote industrialization. |
| (3) | The survey of biotechnology-related information under Article 19 (2) of the Act shall be conducted every year; provided, non-periodic surveys may be conducted whenever deemed necessary by the Minister of Science and ICT. |
| (4) | Organizations subject to a request for biotechnology information and related materials under Article 19 (2) of the Act shall be as follows: |
| 1. | Relevant central administrative agencies and affiliated research institutes; |
| 3. | National and public research institutes; |
| 4. | Government-funded research institutes established under the Act on the Establishment, Operation and Fostering of Government-Funded Research Institutes or the Act on the Establishment, Operation and Fostering of Government-Funded Science and Technology Research Institutes or specific research institutes established under the Specific Research Institutes Support Act; |
| 5. | Schools under subparagraphs 1, 2, 4, and 6 of Article 2 of the Higher Education Act; |
| 6. | Business-affiliated research institutes or medical corporations under Article 14 (1) 2 and 6 of the Basic Research Promotion and Technology Development Support Act; |
| 7. | Other entities determined by the Minister of Science and ICT, which are related to technology development research and industrialization promotion in biotechnology. |
[This Article Added on Nov. 20, 2020]
[Previous Article 15 moved to Article 12-2 <Nov. 20, 2020>]
| Article 15-2 (Establishment of classification system) |
| (1) | Where the head of a relevant central administrative agency intends to establish a biotechnology classification system under Article 20 (1) of the Act (hereinafter referred to as "biotechnology classification system"), he or she shall consult with the Minister of Science and ICT in advance. |
| (2) | Where the head of a relevant central administrative agency intends to establish a biotechnology classification system under paragraph (1), such system may be established in a way that is linked to the National Science and Technology Standard Classification Table under Article 27 (1) of the Framework Act on Science and Technology. |
| (3) | The head of a relevant central administrative agency shall finalize the biotechnology classification system established under paragraph (1) after deliberation by the Council. |
| (4) | The head of a relevant central administrative agency may, if necessary, revise or supplement the biotechnology classification system taking into account the innovation of biotechnologies, the development trend of the biotechnology industry, etc. |
| (5) | Paragraphs (1) through (3) shall apply mutatis mutandis to the procedures for revision or supplementation under paragraph (4). In such cases, "establish" shall be construed as "revise or supplement". |
[This Article Added on Nov. 20, 2020]
| Article 15-3 (Promotion of standardization) |
| (1) | "Matters prescribed by Presidential Decree" in Article 20-2 (1) 4 of the Act means the following policy measures: |
| 1. | Surveying on demand for standards to develop national standards in biotechnology and formulating strategy for standardization; |
| 2. | Supporting the activities of the International Organization for Standardization in biotechnology; |
| 3. | Training experts for the standardization of biotechnologies and the exchange and cooperation with domestic and international experts; |
| 4. | Investigating and analyzing trends in international standards related to biotechnology and establishment of a response system; |
| 5. | Other policy measures deemed necessary for the promotion of standardization in biotechnologies. |
[This Article added on April 22, 2025]
[Previous Article 15-3 moved to Article 15-4 <Apr. 22, 2025>]
| Article 15-4 (Objects and methods of surveys and analyses of biotechnology statistics) |
| (1) | The objects of statistical surveys and analyses under Article 21 (1) of the Act shall be as follows: |
| 1. | Matters regarding the investment in and performance of biotechnology-related research and development, technological levels in biotechnology, and other similar information; |
| 2. | Matters regarding start-up information and investment or performance of enterprises, such as biotechnology-related venture businesses, cluster status by location, and other similar information; |
| 3. | Matters regarding biotechnology-related research facilities and equipment and other similar information; |
| 4. | Matters regarding workforce, etc. supplied and employed by biotechnology-related universities and enterprises, respectively; |
| 5. | Other matters deemed by the Minister of Science and ICT to require surveys and analyses of statistics in order to efficiently establish policies on technology development and industrialization in biotechnology. |
| (2) | Surveys of statistics under paragraph (1) shall be conducted by means of on-site surveys, questionnaires, literature surveys, etc. and if necessary for the efficient surveys of statistics, surveys may be conducted using information and communications networks or electronic methods, such as e-mail. |
[This Article Added on Nov. 20, 2020]
[Moved from Article 15-3; previous Article 15-4 moved to Article 15-5 <Apr. 22, 2025>]
| Article 15-5 (Biotechnology-related regulatory improvement) |
| (1) | The Minister of Science and ICT may, if necessary, organize and operate a joint regulatory improvement team (hereinafter referred to as the "joint regulatory improvement team") comprised of any of the following persons to assist in identifying regulatory gaps need to be improved and reviewing improvement plans with regard to the regulation related to the development and utilization of biotechnologies under Article 22 (2) of the Act: |
| 1. | An employee of a relevant central administrative agency who is appointed by the head of the agency; |
| 2. | An interested party of or expert in the regulation of technology development and utilization in biotechnology. |
| (2) | The joint regulatory improvement team shall identify unnecessary regulation that hinders technological innovation in biotechnology and the creation of new industries and therefore needs improvement, through telephone surveys, face-to-face surveys, questionnaires, etc. and shall prepare improvement plans. |
| (3) | The joint regulatory improvement team shall give a report on the identified regulation and the prepared improvement plan under paragraph (2) to the Council. |
| (4) | The Council shall deliberate and decide on the regulation and the improvement plan reported under paragraph (3). |
| (5) | The Minister of Science and ICT shall notify the head of the relevant central administrative agency of the regulation and the improvement plan that are decided on by the Council pursuant to paragraph (4), and the head of the relevant central administrative agency shall endeavor to improve the relevant regulation in accordance with the notification unless there is a compelling reason not to do so. |
[This Article Added on Nov. 20, 2020]
[Moved from Article 15-4 <Apr. 22, 2025>]
| Article 16 (Designation and operation of medical science and engineering development support organization) |
| (1) | A medical science and engineering development support organization under Article 25 (1) of the Act shall be designated through consultation between the Minister of Science and ICT and the Minister of Health and Welfare. <Amended on Feb. 29, 2008; Mar. 15, 2010; Mar. 23, 2013; Jul. 26, 2017; Nov. 20, 2020> |
| (2) | The medical science and engineering development support organization shall perform the following duties: <Amended on Nov. 20, 2020> |
| 1. | Execution and management of projects to foster medical science and engineering; |
| 2. | Support for academic and research activities in the field of medical science and engineering. |
[This Article Wholly Amended on Jun. 29, 2004]
| Article 17 Deleted. <Jun. 29, 2004> |
| Article 18 Deleted. <Jun. 29, 2004> |
| Article 19 Deleted. <Jun. 29, 2004> |
| Article 20 Deleted. <Jun. 29, 2004> |
| Article 21 Deleted. <Jun. 29, 2004> |
| Article 22 Deleted. <Jun. 29, 2004> |
| Article 23 (Release of goods prior to acceptance of import declaration) |
| (1) | Goods that may be allowed to be released prior to acceptance of import declaration under Article 26 (2) of the Act shall be any of the following which is determined by the Minister of Science and ICT: <Amended on Jul. 26, 2017; Nov. 20, 2020> |
| 2. | Radioactive material reagents; |
| 3. | Microbial strains and animal and plant cell lines; |
| 6. | Biotechnology-related goods corresponding to those referred to in subparagraphs 1 through 5. |
| (2) | A person who intends to import any of the goods listed in paragraph (1) in accordance with the procedures for release of goods prior to acceptance of import declaration shall submit to the Minister of Science and ICT documents stating the name and quantity of the relevant goods, reasons for the need to release the goods prior to acceptance of import declaration, and other similar matters. <Amended on Jul. 26, 2017> |
| (3) | Where the Minister of Science and ICT in receipt of the documents under paragraph (2) examines the contents and recognizes that it is necessary to release the relevant goods prior to acceptance of import declaration, he or she may request the head of the competent customs office to approve the release of the relevant goods prior to acceptance of import declaration in accordance with Article 252 of the Customs Act. In this regard, the head of the competent customs office shall approve the release of the goods prior to acceptance of import declaration unless there is a compelling reason not to do so. <Amended on Jul. 26, 2017> |
[This Article Wholly Amended on Mar. 23, 2013]
| Article 24 (Entrustment of tasks) |
| (1) | The Minister of Science and ICT may, in accordance with Article 27 (2) of the Act, entrust the following tasks that fall under the jurisdiction of the Minister of Science and ICT to an institute specializing in biotechnology policy designated under Article 24 (1) of the Act (hereinafter referred to as the "Policy Center"): <Amended on Apr. 22, 2025> |
| 1. | Fact-finding survey under Article 9 (1) of the Act; |
| 2. | Technology impact assessment under Article 10 (1) of the Act; |
| 2-2. | Demand survey for the designation of promising biotechnologies under Article 11-2 (1) of the Act and Article 11-5 (1) of this Decree; |
| 3. | Collection, management, and utilization of biotechnology information in accordance with Article 19 of the Act; |
| 4. | Establishment, supplementation, and development of the biotechnology classification system under Article 20 (1) of the Act; |
| 4-2. | Investigation of information related to biotechnology standardization under Article 20-2 (1) 2 of the Act; |
| 5. | Survey and analysis of biotechnology statistics under Article 21 of the Act. |
| (2) | Where the Minister of Science and ICT entrusts tasks in accordance with paragraph (1), he or she shall publicly notify the Policy Center to be entrusted and the content of the entrusted tasks. |
[This Article Added on Nov. 20, 2020]
ADDENDUM <Presidential Decree No. 11512, Sep. 22, 1984>
This Decree shall enter into force on the date of its promulgation.
ADDENDA <Presidential Decree No. 13282, Feb. 1, 1991>
Article 1 (Enforcement date)
This Decree shall enter into force on the date of its promulgation.
Articles 2 through 5 Omitted.
ADDENDA <Presidential Decree No. 13870, Mar. 6, 1993>
Article 1 (Enforcement date)
This Decree shall enter into force on the date of its promulgation.
Articles 2 through 5 Omitted.
ADDENDA <Presidential Decree No. 14438, Dec. 23, 1994>
Article 1 (Enforcement date)
This Decree shall enter into force on the date of its promulgation.
Articles 2 through 5 Omitted.
ADDENDA <Presidential Decree No. 14446, Dec. 23, 1994>
Article 1 (Enforcement date)
This Decree shall enter into force on the date of its promulgation. (Proviso Omitted.)
Article 2 Omitted.
Article 3 Omitted.
ADDENDUM <Presidential Decree No. 14731, Jul. 13, 1995>
This Decree shall enter into force on the date of its promulgation.
ADDENDA <Presidential Decree No. 16326, May 24, 1999>
Article 1 (Enforcement date)
This Decree shall enter into force on the date of its promulgation.
Articles 2 through 5 Omitted.
ADDENDA <Presidential Decree No. 17048, Dec. 29, 2000>
Article 1 (Enforcement date)
This Decree shall enter into force on January 1, 2001.
Articles 2 through 8 Omitted.
ADDENDA <Presidential Decree No. 17115, Jan. 29, 2001>
Article 1 (Enforcement date)
This Decree shall enter into force on the date of its promulgation.
Articles 2 through 5 Omitted.
ADDENDUM <Presidential Decree No. 18452, Jun. 29, 2004>
This Decree shall enter into force on July 1, 2004.
ADDENDA <Presidential Decree No. 20740, Feb. 29, 2008>
Article 1 (Enforcement date)
This Decree shall enter into force on the date of its promulgation.
Articles 2 through 7 Omitted.
ADDENDA <Presidential Decree No. 22075, Mar. 15, 2010>
Article 1 (Enforcement date)
This Decree shall enter into force on March 19, 2010. (Proviso Omitted.)
Article 2 Omitted.
ADDENDA <Presidential Decree No. 24423, Mar. 23, 2013>
Article 1 (Enforcement date)
This Decree shall enter into force on the date of its promulgation. (Proviso Omitted.)
Articles 2 through 7 Omitted.
ADDENDA <Presidential Decree No. 25751, Nov. 19, 2014>
Article 1 (Enforcement date)
This Decree shall enter into force on the date of its promulgation; provided, the provisions amending any Presidential Decree which was promulgated before this Decree enters into force but has yet to enter into force, among the Presidential Decrees amended by Article 5 of the Addenda, shall enter into force on the respective date the relevant Presidential Decree enters into force.
Articles 2 through 5 Omitted.
ADDENDA <Presidential Decree No. 28210, Jul. 26, 2017>
Article 1 (Enforcement date)
This Decree shall enter into force on the date of its promulgation.
Articles 2 through 6 Omitted.
ADDENDA <Presidential Decree No. 31168, Nov. 20, 2020>
Article 1 (Enforcement date)
This Decree shall enter into force on November 20, 2020.
Article 2 Omitted.
ADDENDUM <Presidential Decree No. 31380, Jan. 5, 2021>
This Decree shall enter into force on the date of its promulgation. (Proviso Omitted.)
ADDENDUM <Presidential Decree No. 32532, Mar. 15, 2022>
This Decree shall enter into force on March 29, 2022.
ADDENDUM <Presidential Decree No. 35455, Apr. 22, 2025>
This Decree shall enter into force on April 23, 2025.