ACT ON REGULATORY SCIENCE INNOVATION FOR SUPPORTING FOOD AND DRUG SAFETY AND COMMERCIALIZATION

Article 1(Purpose) #

The purpose of this Act is to contribute to enabling citizens to lead safe and healthy lives by reasonably managing the safety of foods, drugs, etc. based on regulatory science for the safe use of foods, drugs, etc. and the prompt commercialization thereof.

Article 2(Definitions) #

The terms used in this Act are defined as follows:

1. The term “foods, drugs, etc.” means any of the following:

(a) Foods, 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) Hygiene products under the Hygiene Products Control Act;

(k) Others prescribed by Presidential Decree, similar to those referred to in items (a) through (j);

2. The term "regulatory science for foods, drugs, etc." means science related to technologies, standards, and approaches in all aspects of safety management, ranging from the evaluation in terms of safety, efficacy, quality, performance, etc. of foods, drugs, etc. to authorization, permission, and use;

3. The term "regulatory science innovation" means a series of processes in which a reasonable regulatory foundation is created to ensure the safe use of foods, drugs, etc. and prompt commercialization thereof by promoting research and development programs under Article 7 and programs for training specialized human resources under Article 14 and by utilizing the outcomes therefrom in order to promote regulatory science for foods, drugs, etc. (hereinafter referred to as "regulatory science").