CHAPTER I GENERAL PROVISIONS
The purpose of this Act is to contribute to the promotion of national health and the development of the national economy by prescribing matters necessary for setting the basic direction and laying the foundation for promoting Korean medicine and pharmaceuticals and promoting research and development of Korean medicine and pharmaceutical technologies.
[This Article Wholly Amended on Oct. 22, 2012]
The terms used in this Act are defined as follows:
| 1. | The term "Korean medicine and pharmaceuticals" means Korean medicine treatment practices based on the Korean medicine traditionally passed down from our ancestors and Korean medicine treatment practices which are scientifically applied and developed based thereon (hereinafter referred to as “Korean medicine treatment”), and herbal medicine business affairs; |
| 2. | The term "herbal medicine business affairs" means producing (including cultivating), processing, manufacturing, preparing, importing, selling, appraising, or storing medicinal herbs, or other matters related to Korean medicine and pharmaceutical technologies; |
| 3. | The term "Korean medicine and pharmaceutical technology" means technologies related to herbal preparation (referring to manufacturing herbal medicine according to the principles of Korean medicine; hereafter in subparagraph 5 the same shall apply) including Korean medicine and pharmaceuticals and all products and services relevant to Korean medicine and pharmaceuticals such as cultivating (including developing excellent varieties), manufacturing, distributing, or storing medicinal herbs; |
| 4. | The term "herbal medicine" means crude drugs collected from animals, plants, or minerals, which are mainly dried, cut, or refined in their original form; |
| 5. | The term "medicinal herb" means medicines used as raw materials to manufacture herbal medicine or for herbal preparation. |
[This Article Wholly Amended on Oct. 22, 2012]
| Article 3 (Responsibility of the State) |
| (1) | The State shall formulate and implement comprehensive policy measures for the development of Korean medicine and pharmaceutical technologies. |
| (2) | A local government shall formulate and implement policy measures for the promotion of Korean medicine and pharmaceutical technologies in consideration of national policy measures and regional characteristics. |
[This Article Wholly Amended on Oct. 22, 2012]
| Article 4 (Promotion of scientification and informatization of Korean medicine and pharmaceutical technology) |
| (1) | The State and a local government shall formulate and implement policy measures necessary to facilitate the scientification and informatization of Korean medicine and pharmaceutical technologies. |
| (2) | In order to enhance the transparency and rationality of policies on Korean medicine and pharmaceutical technologies, the State and a local government shall ensure that private experts or relevant organizations, etc. participate widely in the process of developing and executing policies. |
[This Article Wholly Amended on Oct. 22, 2012]
CHAPTER II FORMULATION OF BASIC POLICY FOR PROMOTING KOREAN MEDICINE AND PHARMACEUTICALS
| Article 5 (Basic directions for promoting Korean medicine and pharmaceuticals) |
The State and a local government shall formulate, manage, and operate various policy measures for promoting Korean medicine and pharmaceuticals in accordance with the following basic directions:
| 1. | Protecting, succeeding to, and developing the characteristics of Korean medicine and pharmaceuticals; |
| 2. | Laying the foundation for the development of Korean medicine and pharmaceuticals; |
| 3. | Informatizing Korean medicine and pharmaceutical technologies; |
| 4. | Systematically managing Korean medicine and pharmaceuticals and standardizing it in conformity with international standards; |
| 5. | Establishing a stable basis for the production of medicinal herbs; |
| 6. | Enhancing the international competitiveness of industries related to Korean medicine and pharmaceuticals and promoting international cooperation; |
| 7. | Supporting and promoting the herbal medicine market. |
[This Article Wholly Amended on Oct. 22, 2012]
| Article 6 (Formulation of comprehensive plans for promoting Korean medicine and pharmaceuticals) |
| (1) | The Minister of Health and Welfare shall formulate a comprehensive plan for the fosterage, development, etc. of Korean medicine and pharmaceuticals (hereinafter referred to as "comprehensive plan") every 5 years, subject to deliberation by the Deliberative Committee on the Development of Korean Medicine and Pharmaceuticals under paragraph (3). |
| (2) | The comprehensive plan shall include the following: |
| 1. | Basic goals and directions for promoting and developing Korean medicine and pharmaceuticals; |
| 2. | Support systems for laying the foundation for researching Korean medicine and pharmaceuticals; |
| 3. | Plans for training and utilizing human resources for Korean medicine and pharmaceuticals; |
| 4. | Plans for improving and supporting Korean medicine and pharmaceutical technologies; |
| 5. | Plans for the globalization of Korean medicine and pharmaceuticals; |
| 6. | Promoting inter-Korean exchange and cooperation in the field of Korean medicine and pharmaceuticals; |
| 7. | Other matters regarding promoting and developing Korean medicine and pharmaceuticals. |
| (3) | In order to deliberate on a comprehensive plan, a Deliberative Committee on the Development of Korean Medicine and Pharmaceuticals shall be established under the jurisdiction of the Minister of Health and Welfare. <Amended on Dec. 11, 2018> |
| (4) | The Deliberative Committee on the Development of Korean Medicine and Pharmaceuticals established under paragraph (3) shall be composed of up to 20 members, including 1 chairperson and 1 vice-chairperson. In such cases, members who are not public officials shall constitute a majority of all members. <Newly Inserted on Dec. 11, 2018> |
| (5) | Other matters necessary for the organization and operation of the Deliberative Committee on the Development of Korean Medicine and Pharmaceuticals under paragraph (3) shall be prescribed by Presidential Decree. <Newly Inserted on Dec. 11, 2018> |
| (6) | Where the Minister of Health and Welfare deems that some of the matters prescribed in the subparagraphs of paragraph (2) are related to the duties of other central administrative agencies, the Minister shall formulate a comprehensive plan after consulting with the head of the relevant central administrative agency. <Amended on Dec. 11, 2018> |
[This Article Wholly Amended on Oct. 22, 2012]
| Article 7 (Formulation and implementation of plans to promote major policy measures) |
When a comprehensive plan is finalized, the Minister of Health and Welfare and the heads of the relevant central administrative agencies shall formulate and implement a plan to promote major policy measures under their jurisdiction every year based on the comprehensive plan.
[This Article Wholly Amended on Oct. 22, 2012]
| Article 8 (Formulation and implementation of regional plans for promoting Korean medicine and pharmaceuticals) |
| (1) | When a comprehensive plan is finalized, the head of a local government shall formulate and implement a regional plan for promoting Korean medicine and pharmaceuticals (hereinafter referred to as "regional plan") in consideration of the circumstances of the local government, as prescribed by relevant statutes and regulations. |
| (2) | The head of a local government shall submit a regional plan formulated pursuant to paragraph (1) to the Minister of Health and Welfare. <Newly Inserted on Jul. 18, 2023> |
| (3) | The head of a local government may designate an institution or organization to implement a regional plan. <Amended on Jul. 18, 2023> |
[This Article Wholly Amended on Oct. 22, 2012]
| Article 9 (Cooperation in formulating plans) |
| (1) | The Minister of Health and Welfare, the heads of relevant central administrative agencies, and the heads of local governments may request relevant institutions, organizations, etc. to extend cooperation, such as the provision of data, if necessary for the formulation and implementation of a comprehensive plan, plans to implement major policy measures, or regional plans under their jurisdiction. |
| (2) | The relevant institutions, organizations, etc. in receipt of a request for cooperation under paragraph (1) shall comply with such request, unless there is a compelling reason not to do so. |
[This Article Wholly Amended on Oct. 22, 2012]
CHAPTER II PROMOTION OF PROJECTS FOR DEVELOPMENT OF KOREAN MEDICINE AND PHARMACEUTICAL TECHNOLOGIES
| Article 10 (Promotion of projects for research and development of Korean medicine and pharmaceuticals) |
| (1) | The State and a local government shall formulate supportive policy measures to encourage research and development of health and medical service industrial technologies using Korean medicine treatment and herbal medicines, to turn Korean medicine and pharmaceutical technologies and products related to Korean medicine and pharmaceuticals into a health and medical service industry, and to enhance their international competitiveness. |
| (2) | The State and a local government shall promote joint research and collaborative research among academia, research institutes, and industry in order to efficiently promote research and technological development of Korean medicine and pharmaceuticals. |
| (3) | The State and a local government shall establish a clinical trial and verification system for Korean medicine treatments and products related to Korean medicine and pharmaceuticals. |
| (4) | If deemed necessary for the efficient promotion of research and development, etc. under paragraph (1), the State and a local government may designate an institution or organization to conduct research and development, etc. |
| (5) | The State and a local government may provide subsidies to cover expenses incurred by institutions or organizations in conducting research, development, etc. pursuant to paragraph (4). |
[This Article Wholly Amended on Oct. 22, 2012]
| Article 11 (Establishment of Korean medicine clinical center) |
| (1) | The Minister of Health and Welfare may establish a Korean medicine clinical center for clinical trials on Korean medicine treatments and products related to Korean medicine and pharmaceuticals under Article 10 (3). |
| (2) | If the Minister of Health and Welfare deems it necessary for the efficient operation of a Korean medicine clinical center under paragraph (1), the Minister may designate an institution or organization performing Korean medicine treatments as a Korean medicine clinical center. |
[This Article Wholly Amended on Oct. 22, 2012]
CHAPTER IV ESTABLISHMENT OF FOUNDATION FOR OR KOREAN MEDICINE INDUSTRY
| Article 12 (Development of Korean medicine industrial complex) |
| (1) | The State and a local government shall formulate policy measures necessary for the creation and supply of industrial locations, support for infrastructure for the Korean medicine and pharmaceutical industry, etc. in order to lay the foundation for the Korean medicine and pharmaceutical industry, and may provide administrative and financial support when private individuals jointly create a Korean medicine and pharmaceutical industrial complex. |
| (2) | Matters regarding support for the development of a Korean medicine industrial complex under paragraph (1) shall be subject to deliberation by the Deliberative Committee on the Development of Korean Medicine and Pharmaceuticals under Article 6 (3). <Amended on Dec. 11, 2018> |
| (3) | Articles 6, 7, 7, 7-4, 10 through 13, 13-2, 13-3, 16, 16-2, 16, 16-2, 17, 17-2, 18, 19-2, 18, 19-2, 20, 20-2, 21, 26, 28, 38, 37, 38, 38-2, and Chapter V of the Industrial Sites and Development Act shall apply to the development of a Korean medicine industrial complex under paragraph (1). |
| (4) | Matters necessary for support for and deliberation on a Korean medicine industrial complex under paragraphs (1) and (2) shall be prescribed by Presidential Decree. <Amended on Dec. 11, 2018> |
[This Article Wholly Amended on Oct. 22, 2012]
| Article 13 (National Institute for Korean Medicine Development) |
| (1) | The Minister of Health and Welfare shall establish a National Institute for Korean Medicine Development (hereinafter referred to as the "Institute") to efficiently support the promotion of Korean medicine and pharmaceutical technologies. <Amended on Dec. 11, 2018> |
| (2) | The Institute shall be a corporation and shall be established at the time it registers such establishment at the location of its main office. <Amended on Dec. 11, 2018> |
| (3) | The articles of incorporation of the Institute shall contain the following matters. <Amended on Dec. 11, 2018> |
| 3. | The location of the main office; |
| 4. | Matters regarding assets; |
| 5. | Matters regarding the executive officers and employees; |
| 6. | The operation of the board of directors; |
| 7. | The scope, details, and execution of the business; |
| 9. | The methods of public announcement; |
| 10. | Modification of the articles of incorporation; |
| 11. | Other important matters regarding the operation of the Institute. |
| (4) | If the Institute intends to modify matters entered in the articles of incorporation, it shall obtain authorization from the Minister of Health and Welfare. <Newly Inserted on Dec. 11, 2018> |
| (5) | The Institute shall perform the following business affairs: <Newly Inserted on Dec. 11, 2018> |
| 1. | Promoting the scientification and informatization of Korean medicine and pharmaceutical technologies under Article 4; |
| 2. | Supporting the cultivation of excellent medicinal herbs and the manufacturing and distribution of herbal medicine under Article 14; |
| 3. | Supporting the transmission and development of traditional herbal medicine markets and the preservation and research of medicinal herb varieties; |
| 4. | Developing policies related to promoting Korean medicine and pharmaceuticals and supporting the formulation of comprehensive plans under Article 6; |
| 5. | Projects for enhancing joint cooperation in and outside Korea and international competitiveness in relation to Korean medicine and pharmaceuticals; |
| 6. | Projects for public relations and content development related to the scientification of Korean medicine and pharmaceutical technologies; |
| 7. | Projects for supporting the industrialization of Korean medicine and pharmaceutical technologies; |
| 8. | Projects for nurturing professionals to foster industries related to Korean medicine and pharmaceutical technologies; |
| 9. | Other projects regarding the promoting and development of Korean medicine and pharmaceuticals, which are entrusted by the Minister of Health and Welfare, the heads of relevant administrative agencies, or local governments. |
| (6) | The Government may make contributions to cover expenses necessary for the projects and operation of the Institute within the budget. <Newly Inserted on Dec. 11, 2018> |
| (7) | Except as provided in this Act, the provisions of the Civil Act governing incorporated foundations shall apply mutatis mutandis to the Institute. <Newly Inserted on Dec. 11, 2018> |
[This Article Wholly Amended on Oct. 22, 2012]
[Title Amended on Dec. 11, 2018]
CHAPTER V IMPROVEMENT OF QUALITY OF HERBAL MEDICINES
| Article 14 (Good Practices for Herbal Medicines) |
| (1) | The Minister of Health and Welfare may formulate and implement Good Agricultural Practices, Good Supply Practices, and Good Manufacturing Practices for Herbal Medicines (hereinafter referred to as "Good Practices for Herbal Medicines"), if necessary for the adequate quality control of herbal medicines. |
| (2) | The Minister of Health and Welfare may require drug manufacturers and Korean medicine institutions to use medicinal herbs and herbal medicines in conformity with the Good Practices for Herbal Medicines. |
[This Article Wholly Amended on Oct. 22, 2012]
| Article 15 (Improvement of quality of herbal medicines and advancement of their distribution) |
| (1) | In order to improve the quality of herbal medicines, the Minister of Health and Welfare shall formulate policy measures necessary for each stage such as the production of medicinal herbs and the manufacturing and distribution of herbal medicines. |
| (2) | The Minister of Health and Welfare shall conduct surveys and research on the relevant policies, systems, current status, etc. necessary for the improvement of the quality of herbal medicines, the advancement of the distribution, storage, etc. of herbal medicines and the international trade cooperation for herbal medicines. |
[This Article Wholly Amended on Oct. 22, 2012]
CHAPTER Ⅵ SUPPLEMENTARY PROVISIONS
| Article 16 (Subsidization of expenses) |
| (1) | The State may provide subsidies to cover all or part of expenses incurred by a local government in implementing a regional plan within the budget. |
| (2) | A local government may provide support to an institution or organization that implements a regional plan pursuant to Article 8 (3). <Amended on Jul. 18, 2023> |
[This Article Wholly Amended on Oct. 22, 2012]
| Article 17 (Delegation or entrustment of authority) |
The Minister of Health and Welfare may delegate or entrust part of his or her authority under this Act to the head of a relevant institution or organization, as prescribed by Presidential Decree.
[This Article Wholly Amended on Oct. 22, 2012]
| Article 18 (Relationship to other statutes) |
Except as provided in this Act, the Health and Medical Service Technology Promotion Act shall apply to matters regarding the promotion of Korean medicine and pharmaceuticals, such as research and development of Korean medicine and pharmaceutical technologies. [This Article Wholly Amended on Oct. 22, 2012]
ADDENDUM <Act No. 6965, Aug. 6, 2003>
This Act shall enter into force 1 year after the date of its promulgation.
ADDENDUM <Act No. 8645, Oct. 17, 2007>
This Act shall enter into force on the date of its promulgation.
ADDENDUM <Act No. 8852, Feb. 29, 2008>
Article 1 (Enforcement date)
This Act shall enter into force on the date of its promulgation; provided, ... <omitted> ... the amended provisions of the statutes which were promulgated before this Act enters into force but the enforcement dates of which have not yet arrived, from among the statutes amended under Article 6 of the Addenda, shall enter into force on the enforcement dates of the respective statutes. Articles 2 through 7 Omitted.
ADDENDA <Act No. 9932, Jan. 18, 2010>
Article 1 (Enforcement date)
This Decree shall enter into force 2 months after the date of its promulgation. (Proviso Omitted.)
Article 2 through 6 Omitted.
ADDENDUM <Act No. 10852, Jul. 14, 2011>
This Act shall enter into force on the date of its promulgation.
ADDENDUM <Act No. 11524, Oct. 22, 2012>
This Act shall enter into force on the date of its promulgation.
ADDENDA <Act No. 15910, Dec. 11, 2018>
Article 1 (Enforcement date)
This Act shall enter into force 6 months after the date of its promulgation.
Article 2 (Transitional measures concerning composition of members)
| (1) | Where the amended provisions of the latter part of Article 6 (4) are not complied with as at the time of appointing or commissioning a member of the Deliberative Committee on the Development of Korean Medicine and Pharmaceuticals after this Act enters into force, a member who is not a public official shall be commissioned until the requirements prescribed in the relevant amended provisions are satisfied. |
| (2) | The previous provisions shall apply to the composition of the members of the Deliberative Committee on the Development of Korean Medicine and Pharmaceuticals until the amended provisions of the latter part of Article 6 (4) are complied with pursuant to paragraph (1). |
Article 3 (Transitional measures concerning Korean Medicine Promotion Foundation)
| (1) | The Korean Medicine Promotion Foundation established as an incorporated foundation with permission from the Minister of Health and Welfare pursuant to Article 32 of the Civil Act as at the time this Act enters into force (hereafter in this Article referred to as the "Korean Medicine Promotion Foundation") may file an application for approval with the Minister of Health and Welfare to allow the Institute established pursuant to the amended provisions of Article 13 to succeed to all property, rights, and obligations thereof by a resolution of the board of directors. |
| (2) | Notwithstanding the provisions of the Civil Act regarding the dissolution and liquidation of corporations in the Civil Act, the Korean Medicine Promotion Foundation which has obtained approval from the Minister of Health and Welfare pursuant to paragraph (1) shall be deemed dissolved simultaneously with the establishment of the Institute under this Act, and the Institute shall comprehensively succeed to all properties, rights, and obligations belonging to the Korean Medicine Promotion Foundation. In such cases, the name of the Korean Medicine Promotion Foundation indicated in the register on property, rights, and obligations and in other official books shall be deemed the name of the Institute under this Act. |
| (3) | The executive officers and employees of the Korean Medicine Promotion Foundation as at the time the Institute is established shall be deemed the executive officers and employees of the Institute under this Act. |
| (4) | The values of the properties to be comprehensively succeeded by the Institute pursuant to paragraph (2) shall be their book values as at the time of succession. |
ADDENDUM <Act No. 19556, Jul. 18, 2023>
This Act shall enter into force 6 months after the date of its promulgation.