ACT ON THE PROMOTION OF RESEARCH AND DEVELOPMENT OF NEW DRUGS DERIVED FROM NATURAL SUBSTANCES
Act No. 6165, Jan. 12, 2000
Amended by Act No. 6400, Jan. 29, 2001
Act No. 8852, Feb. 29, 2008
Act No. 9932, Jan. 18, 2010
Act No. 11690, Mar. 23, 2013
Act No. 11978, Jul. 30, 2013
Act No. 12844, Nov. 19, 2014
Act No. 14839, Jul. 26, 2017
Act No. 16263, Jan. 15, 2019
The purpose of this Act is to promote natural substance science, lay the foundation for research and development of new drugs derived from natural substances, and facilitate the industrialization of technologies developed through such research and development, thereby contributing to the improvement of public health and the development of the national economy.
[This Article Wholly Amended on Jan. 15, 2019]
The terms used in this Act are defined as follows:
| 1. | The term “natural substance” means a substance of biological origin, including organisms such as animals and plants inhabiting terrestrial and marine environments, as well as products derived from the cells or tissue cultures of such organisms; |
| 2. | The term “element of natural substances” means a substance contained in a natural substance that possesses biological activity, such as exerting direct or indirect effects on a living organism; |
| 3. | The term “new drug derived from natural substances” means a drug developed through research using an element of natural substances, whose composition, efficacy, or other characteristics are new; |
| 4. | The term “natural substance science” means the academic discipline and technology that studies and utilizes natural substances and their elements, including the isolation of elements of natural substances, identification of their chemical structures, investigation of biological activity, and exploration of effective methods for production and manufacturing. |
[This Article Wholly Amended on Jan. 15, 2019]
| Article 3 (Formulation of research and development promotion plan) |
| (1) | The Minister of Health and Welfare shall formulate and implement a plan to promote research and development of new drugs derived from natural substances, following deliberation by the Health and Medical Technology Policy Review Committee under Article 6 of the Health and Medical Technology Promotion Act. <Amended on Jul. 30 2013> |
| (2) | A plan under paragraph (1) (hereinafter referred to as "research and development promotion plan") shall include the following: <Amended on Jan. 15, 2019> |
| 1. | Mid- and long-term objectives and details of research and development of new drugs derived from natural substances; |
| 2. | Measures to secure financial resources for research and development of new drugs derived from natural substances; |
| 3. | Matters regarding the development and efficient utilization of human resources necessary for research and development of new drugs derived from natural substances; |
| 4. | Matters regarding the utilization and preservation of the outcomes of research and development of new drugs derived from natural substances; |
| 5. | Matters regarding research and advancement of natural substance science; |
| 6. | Other important matters necessary to promote research and development of new drugs derived from natural substances. |
| (3) | If necessary for formulating and implementing the research and development promotion plan under paragraph (1), the Minister of Health and Welfare may request cooperation from relevant agencies, organizations, etc.; in such cases, the relevant agencies, organizations, etc. shall comply with such request unless there is a compelling reason not to do so. <Amended on Jan. 15 2019> |
| (4) | Matters necessary for the formulation and implementation of the research and development promotion plan shall be prescribed by Presidential Decree. <Amended on Jan. 15 2019> |
[Title Amended on Jan. 15, 2019]
| Article 4 Deleted. <Jul. 30, 2013> |
| Article 5 Deleted. <Jul. 30, 2013> |
| Article 6 (Expansion of investments in research and development) |
The Minister of Health and Welfare shall make active efforts to expand investment in research and development of new drugs derived from natural substances.
[This Article Wholly Amended on Jan. 15, 2019]
| Article 7 (International cooperation) |
The Minister of Health and Welfare shall endeavor to promote international cooperation regarding research and development of new drugs derived from natural substances and shall establish efficient measures to introduce advanced technologies.
[This Article Wholly Amended on Jan. 15, 2019]
| Article 8 (Promotion of joint and cooperative research and development) |
The Minister of Health and Welfare shall promote joint and collaborative research and development among industry, academia, and research institutions to efficiently promote research and development of new drugs derived from natural substances.
[This Article Wholly Amended on Jan. 15, 2019]
| Article 9 (Support for relevant industrial enterprises) |
The Minister of Health and Welfare shall formulate support policy measures necessary to facilitate the industrialization of the outcomes of research and development of new drugs derived from natural substances.
[This Article Wholly Amended on Jan. 15, 2019]
| Article 10 (Collection and dissemination of information on research and development) |
The Minister of Health and Welfare shall collect and analyze information regarding domestic and international research and development of new drugs derived from natural substances, including research and development trends and market trends, and shall systematically and comprehensively manage and disseminate such information to efficiently promote research and development of new drugs derived from natural substances.
[This Article Wholly Amended on Jan. 15, 2019]
| Article 11 (Promotion of natural substance science) |
| (1) | The Government shall prepare the following policy measures in order to foster and develop natural substance science: |
| 1. | The Minister of Education: Training of professionals to promote research in natural substance science, and the promotion and support of basic research in natural substance science; |
| 2. | The Minister of Science and ICT: Development, promotion, and support of basic and advanced technologies related to natural substance science; |
| 3. | The Minister of Agriculture, Food and Rural Affairs: Promotion and support of basic research regarding the development, conservation, production, utilization, etc. of terrestrial natural substance resources; |
| 4. | The Minister of Health and Welfare: Support for research and development of natural substance science applicable to such fields as health, medicine, and food hygiene, and the promotion and support of clinical trial-related projects; |
| 5. | The Minister of Oceans and Fisheries: Promotion and support of basic research regarding such activities as the development, conservation, production, and utilization of marine natural substance resources; |
| (2) | The Minister of Health and Welfare shall support research regarding the utilization and preservation of natural substance science and natural substance resources, and establish a public support system to maintain and develop an organic cooperative framework among industry, academia, and research institutions in the field of natural substance science. |
[This Article Wholly Amended on Jan. 15, 2019]
| Article 12 (Designation and utilization of relevant specialized institutions and organizations) |
The Minister of Health and Welfare may designate or utilize relevant specialized institutions and organizations to facilitate joint and collaborative research and development under Article 8, the management and dissemination of research and development information under Article 10, and the support for research on natural substance science and natural substance resources and the establishment of a support system to promote cooperation among industry, academia, and research institutions under Article 11 (2). [This Article Wholly Amended on Jan. 15, 2019]
| Article 13 (Tax reduction and exemption) |
The Government may reduce or exempt customs duties and value-added tax, in accordance with the Customs Act and the Value-Added Tax Act, on materials, equipment, and reagents that are necessary for research and development activities related to natural substance science or new drugs derived from natural substances and that must be imported due to the impossibility of domestic production. [This Article Wholly Amended on Jan. 15, 2019]
| Article 14 (Relationship to other statutes) |
[This Article Wholly Amended on Jan. 15, 2019]
ADDENDUM <Act No. 6165, Jan. 12, 2000>
This Act shall enter into force 6 months after the date of its promulgation.
ADDENDA <Act No. 6400, Jan. 29, 2001>
Article 1 (Enforcement date)
This Act shall enter into force on the date of its promulgation. (Proviso Omitted.)
ADDENDA <Act No. 8852, Feb. 29, 2008>
Article 1 (Enforcement date)
This Act shall enter into force on the date of its promulgation; provided, ... the amendments to the Acts to be amended pursuant to Article 6 of the Addenda, which were promulgated before this Act enters into force but the enforcement dates of which have yet to arrive, shall enter into force on the enforcement date of the relevant Act.
ADDENDA <Act No. 9932, Jan. 18, 2010>
Article 1 (Enforcement date)
This Act shall enter into force 2 months after the date of its promulgation. (Proviso Omitted.)
ADDENDA <Act No. 11690, Mar. 23, 2013>
Article 1 (Enforcement date)
| (1) | This Act shall enter into force on the date of its promulgation. |
ADDENDUM <Act No. 11978, Jul. 30, 2013>
This Act shall enter into force 6 months after the date of its promulgation.
ADDENDA <Act No. 12844, Nov. 19, 2014>
Article 1 (Enforcement date)
This Act shall enter into force on the date of its promulgation; provided, the amended parts of the Acts which were promulgated before this Act enters into force but the enforcement dates of which have not arrived yet among the Acts amended pursuant to Article 6 of the Addenda shall respectively enter into force on the enforcement of such Acts.
ADDENDA <Act No. 14839, Jul. 26, 2017>
Article 1 (Enforcement date)
| (1) | This Act shall enter into force on the date of its promulgation; provided, the provisions amending any Act that was promulgated before this Act enters into force but has yet to enter into force, among the Acts amended under Article 5 of the Addenda, shall enter into force on the respective date the relevant Act enters into force. |
ADDENDUM <Act No. 16263, Jan. 15, 2019>
This Act shall enter into force on the date of its promulgation.