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

Article 1(Purpose) #

The purpose of this Decree is to prescribe the matters mandated by the Act on Regulatory Science Innovation for Supporting Food and Drug Safety and Commercialization and matters necessary for the enforcement thereof.

Article 2(Scope of food and drugs) #

"Others prescribed by Presidential Decree" in subparagraph 1k of Article 2 of the Act on Regulatory Science Innovation for Supporting Food and Drug Safety and Commercialization (hereinafter referred to as the "Act") means either of the following:

1. Laboratory animals defined in subparagraph 2 of Article 2 of the Laboratory Animal Act;

2. Human tissues defined in subparagraph 1 of Article 3 of the Safety and Management of Human Tissue Act.

Article 3(Formulation of master plans for regulatory science innovation) #

If the Minister of Food and Drug Safety formulates a master plan for regulatory science innovation under Article 5(1) of the Act (hereinafter referred to as "master plan"), he or she shall notify the heads of relevant central administrative agencies thereof and post the details thereof on the website, etc. of the Ministry of Food and Drug Safety.

Article 4(Formulation of annual action plans) #

(1) If the Minister of Food and Drug Safety formulates an annual action plan under Article 5(4) of the Act (hereinafter referred to as "action plan"), he or she shall submit it for deliberation by the Regulatory Science Innovation Committee for Foods and Drugs under Article 6(1) of the Act.

(2) An action plan shall include the following matters:

1. Directions for the promotion of regulatory science innovation by year and by field and strategies therefor;