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1 w wz 16«2y Kor. J. Clin. Pharm., Vol. 16, No ù txƒ š x B Á xk B Á C Á z B B w w w C w Regulatory System of Quasi-drugs in Korea Hyun Soon Sohn a, Hyun Taek Shin a, In Sook Song b, and Hyo Jung Jun a a College of Pharmacy, b Drug Information Research Institute, Sookmyung Women's University, Seoul, Korea The study was aimed to recommend the ways for improving regulatory system of quasi-drugs in governmental authority by comparing with other countries. According to the regulations, the scope of quasi-drugs includes 3 categories of 1) the health aids made of textile, rubber and paper, 2) the health aids which have very minimal effects or no any effects on humans, and 3) disinfectants and pesticides. In US, these quasi-drugs in Korea are classified into 5 categories of medical device, cosmetics, OTC drugs, dietary supplements and pesticides. To improve quasi-drugs administration in Korea, it is concluded that several measures should be implemented : 1) establish clear criteria for classifying into quasi-drugs and more detailed guidelines on designation of quasi-drugs, 2) reform current regulations to meet 3-categories characteristics, supplement detailed guidelines on quasi-drugs administration for effective application process, and update relevant regulations for efficacy, safety and quality, 3) update quasi-drug monographs,4) re-evaluate current classification of individual quasi-drugs, 5) develop comprehensive list by ingredients, 6) reform post-marketing management system for safety and quality, 7) strengthen the review agency function by increasing the number of experts, 8) develop the database for quasi-drugs for effective information management. Key words - Quasi-drug, Regulatory review system, Regulatory process, Regulations xw t j Áš t, w w ù w w t,, 2003 x 2,700 t 7,900 1) ³ ƒ g (Table 1) t t t t mw z, x ƒ 18 w š xƒ» t ³ š. t ƒ ƒ w t ù y sww» w w ƒ w w sƒ ƒ v w. p xƒ z ƒ v w t ù p w,»k ƒ t xƒ z š ƒ. t Correspondence to : xk w w w q 2ƒ Tel: , Fax: shingo@sdic.sookmyung.ac.kr w» t w w. ù t xƒ š w q wš, ü t t ü xƒ w ù wš, ü t xƒ w w» w wš w. ù t ³ mw t, t xƒ xƒ, z w w w š, t q w» wš l t xƒ» w w. wr, ù t w t ü xƒ x k mw üá w. w üá xy w w k w š w w t xƒ 123

2 124 Kor. J. Clin. Pharm., Vol. 16, No. 2, 2006 Table 1. Manufacturing volume of quasi-drugs in Korea Drug classification No. No. of manufacturer No. of product Manufacturing amount (+000 won) 111 systematic anesthetic 1 1 1,136, ophthalmic product ,823, dental product 5 6 1,871, miscellaneous urino-genital and anal product ,605, external disinfectant ,804, pain reliever, itching reliever, astringent, anti-inflammatory agent , skin softener: including corrosive agent , hair products: hair restorer, hair remover, hair dye, hair tonic ,689, bathing product , miscellaneous external agent ,708, vitamin C and P ,850, vitamin combination: excluding vitamin AD mixture 4 5 1,050, miscellaneous nutritional tonic 1 1 1,603, insecticide , miscellaneous public hygiene product , products not for treatment 2 2 4,397,854 J01 sanitary napkin ,961,846 J02 tooth paste ,976,472 J03 hair dye 28 1, ,768,269 J04 pesticide ,582,388 J99 miscellaneous , sanitation product ,505,955 Total 254 2, ,784,294 source : Manufacturing volume of quasi-drugs in 2003 reported by KPMA w. ü txƒ (1) t : xw 2) ( ) tá t Á Á Á Á Á q»k w» w» t» w. 2 7 w t ƒy 1 w w t w : e Á Á e Á š t w, w w ù w w,»» ƒ w, ³? w. wr, t š t wš 2) ƒ w t wš. (2) t ³ 2,3) : t, w³e t ƒ», t»» w w œ. t w š t y tá t ƒ t š, t w t t š tá t Á t xƒ ( š) m w ³, t w» x, t w», tá t y t k» x, ³Á xƒ ( š) w ³. t» t xƒ ³ š t w ³ t ³ sw t w w w. t... t t ³,, t» x ³, t t», t Á z w ³, t ³, t x», t x», x» t xƒ w w ³. w r ³ yw w w ³ ( y š ), yw w x» w ³ ( y š ). t ³ t w sw

3 ù t xƒ š 125, t» x ³ 2 (» x ) š, t w, 3 ( ) w, t t» 4 t2 t t» (, e,, v q, w k,, )» wš (3) t xƒ 2,3) : 1) Á z : t Á z w ³, t t w t» ww t, t œ ( sw) w œ, t t š w ù xƒ z ww t t t Á z. ù t t» ww w ƒ ƒ sww Á z ƒ v w. t Á z w ³ 5 ( t ) 3w ³ xƒ( š) w ³ 20 t Á z w w w. 2)» x : t w» x, š ù œ» x mƒ. 3) ( )t xƒ : tá t Á t xƒ ( š) m w ³. Á z» x z ƒ w. Á z m Á z v w,» x m» x w wš, t xƒ w t Á q š w w v w. wr, ³Á t, w ³ xƒ( š) w ³, ¼ y w Á z,» x m xƒ( š)w š, y wƒ xƒ( š) wwš. (4) z 2) : t ³. t Á š z Á Ásƒw w w w w» w. (5)» 3) : t ƒ t Á w w wš, t t xƒ w t t w. t xƒ w t t q wš, Á z t tsƒ y tá tq w, w k tq. t z v w. txƒ (1) ù t t ü : t ƒ ù t t š w (Table 2). 1) 2 7w 1y ³ w t( Á š ) : (, ks), ƒ ( j, ), (, k, š, mx k - lj ), k, š»» š. 2) 2 7w 2y ³ w t : t y t(cosmetics), t(otc),»» (medical devices), t (dietary supplements) (pesticides) š.,,, e,,, e y t w t» w. t»» t.»» t gkp t š, ü w k t š. wr, w q Á»,,»v. 3) 2 7w 3y ³ w t :, š ù ù w ƒ» w. (2) xƒ : ù t ü 5ƒ,, OTC, cosmetics, dietary supplement, medical device pesticide xƒ. 1) t(otc) 4) : OTC(over-the-counter) Federal Food, Drug, and Cosmetics Act( w FD&C Act w) ³ w w 21 Code of Federal Regulation(21CFR) Part 330». OTC q w OTC Drug Monograph wš, ³ z w», GMP(Good Manufacturing Practice), t» w Ÿš. OTC t t» Drug Facts x w t Nutrition Facts t Supplement Facts w OTC t» t x k. OTC Ÿš

4 126 Kor. J. Clin. Pharm., Vol. 16, No. 2, 2006 Table 2. US classification of quasi-drugs Current quasi-drugs in Korea US classification Textile, rubber or equivalent sanitary napkin sanitary napkin for menstrual blood disposal productsgfor treatment, alleviation, tampon for menstrual blood disposal disposal or prevention of disease cover mask in hunman or animal eye bandage bandgae bandage elastic bandage plaster bandage round elastic bandage gauze sanitary cotton adhesive plaster Products, not instrument nor machine, having mild effect or no direct action to human Insecticides, pesticides, and products with similar purpose used for preventing infectious disease products preventing bad breath or body odor hair products for tonic, dying, removal, etc. oral cavity dental rinse deodorant talcum powder tooth paste bathing product hair loss preventing product or hair tonic hairdye having slight effect on human external product for hair removal exterminating, preventing, repellenting and attracting pesticides target flies, mosquitoes, etc. for human or animal health product for contact lenses cigar-typed smoking deterrent supplement not including tabacco, and spray- or gum-typed nonsmoking supplement for reduction of smoking wants external disinfectant external spray cataplasm C C C P OTC or OTC OTC internal preparations low strength vitamin and mineral preparation DS nutritional tonic DS product for mouth hygiene, etc. snore-preventing supplement tooth-whitening product product for extermination or pesticide P prevention of insect or animal rodenticide P disinfectant not applied to human body directly alcohols, aldehydes, cresol, and soap-typed disinfectant other product for prevention of infectious disease OTC: Over-The-Counter, C: Cosmetics, DS: Dietary Supplement, : Medical Device, P: Pesticides source : 1) Status of OTC rulemakings: The Milestone List as of 1/1/2006 ( source : 2) OTC drug product and ingredient references ( source : 3) Medical device listing ( source : 4) Overview of Dietary Supplement ( source : 5) Cosmetic Products and Ingredients ( source : 6) Compendium of Pesticide Common Names ( Federal Trade Commission ³ w t» w ü FDAƒ w. OTC xƒ FDA Center for Drug Evaluation and Research ü OTC Drug Products ƒ w. 2) y t(cosmetics) 5,6) : ù» y j ãš y Áòwš w t y t w : kf, w, y t, j t, y t,, t, q, t,, t,» t,,,, k t. ù, ƒ e y t š, y t ù» w e ù Áe w ( : e w e, y j, y k, w w, t

5 ù t xƒ š 127 ) t y t t ³. y t t OTC FD&C Act ³ š 21CFR Part Part 73, y t FDA ³ q xƒ v w., ƒ FDAƒ y w y t v (Voluntary Cosmetic Registration Program, w VCRP w) mw FDA l w m w. y» t w y t w w š w³, w w, w» t w t z t»w w. FDA y t Áq t y w w w x «w. y t ƒ t q w t y š t w w. FDA Office of Cosmetics and Colors ƒ VCRP qz š w. 3) t (dietary supplement) 6) : t w» w w w w t w t w (Dietary Supplement Health and Education Act) t ƒ š t» w ³. t FDA v w t wš t ü w w w. t t t š, q mƒ v w ù z FDA w w. q z ƒ FDA t z wš n e w. w w w š ù FDA šw «. t FDA Center for Food Safety and Applied Nutrition ƒ. 4)»»(medical device) 7) :»»»,»,, e,,»k w ù t t sww. œ,, e, ü» w e ü yw mw š w w.»» FD&C w ³ 21CFR Part ».»» xƒ, w t»» w y,, v w w.»» x w ƒ w» z y v w ³ 3 wš, ( 45%), ( 47%), ( 8%) w. 1 (Class I) ³ x ƒ ƒ ûš w ³ yw š,, x» w., FDA qw»», GMP, t» w, q š ƒ q š ù GMP ƒ. 2 (Class II) ³ p ³ q {, rv,» w»»ƒ w, ³ z y w. p ³ w p t» w,» qz ƒ sw. 3 (Class III) ³ q xƒ. ³ p ³ z y w ƒ w ³.» (» ) w, w w w x, w ù ƒ š x» z y w q x ƒƒ v. FD&C Act Part , 3 w. q xƒ FDA t» ù t, z ƒ v w. Medical Device Reporting MEDWATCH v w w wr, FDA 2, 3»» z w qz (Postmarket Surveillance Studies) w : w w»» š, 1»» š,»»»» š. wrfda 2, 3»» y ¾ w»» (Device Tracking) v ww w.»» FDA Center for Devices and Radiological Health w. 5) (pesticide) 8) : w w ù ù ù vw y j» w, š š w,»,,, ³,, z, w³,, yw p ù ü» w w. y y (Environmental Protection Agency), ³ (Federal Insecticide, Fungicide, and Rodenticide Act) FD&C Act w ³. y y š, t» w w ù y w w w. ³ y y, (Department of Agriculture) FDAƒ wì w.

6 128 Kor. J. Clin. Pharm., Vol. 16, No. 2, 2006 y y ³ ³ w. y y t t x e FD&C Act ³ wš, w x e ³ w FDAƒ w. ù ù t w t t, y t, t,»», š š xƒ ƒ y w. ù t xƒ s w ƒ w. ù, ù t t 5ƒ š, p ƒ t ù t ü wù š y w. wr, ƒ š w, t t y yw, ƒe ƒ w 2004 ü t j y w. t w t» Á»»ƒ w t t w š š, ù t x ù ƒ y., x y š w ù w t w ƒ v w. ü txƒ (1) t» yy : t w wš q w œ v w š q ƒ ƒ w ƒ r w t y. ù, x t 3ƒ t wù» t : 1).š t :»»»» 1. Áe Á Á e» Á» Á eá w t s w š w t., t 1. e Á Á e Áš t w. w p ƒ t» Á» Á eá»», Áš t š. k Áš t š ù mx k ( lj )»» wš»» š,»» w š. 2) w t : t w t sw t q x ù t m w ƒ y t ƒ w w. yd š w t,»», y t ƒ w t : gkp t - t,»». w k - t, t, t 3ƒ ƒ w, w w t t q ƒ w. - e j ù g v ƒ»» š, e y t š. 3) ³ - ³Á ( g,, j, xk ³ )»» š., t t mw» y w j wz t p š w w» v w. ù w»», y t, t, t, t» w 5ƒ» t» w ƒ e wš» w š w t» y w. ü p w ƒ w yw ƒ. y d w t š 5ƒ mw ù, ù y p t ƒ p» xw» t, t,»», y t y w w ³ y» w w. t t, t t ƒ y» x w yw w. (2) t n : x t t t š, ƒ š w e n wš œ w.» t ƒ t y ƒ w y w t w m v w. (3) t xƒ ³ : t» t w, xƒ w w š, m z ƒ. t ³ w t p

7 ù t xƒ š 129 w v w, p, t 1, 2, 3 w y ³, y w xƒ y y w v ƒ. w ³ w ù w e ˆ š z eƒ ³ e w y w, xƒ ³ w v w : 1) t ³ Ámw: x t xƒ ³ t, mww ³ yw y ywš ³ w¾ sw w r œw w. 2) t p Á z» :» t w w w t» š w š, t» ù Á z p w w Á z e w» w, p t Á z» w. ³Á t Á z,» x,, w œ ³Á xƒ( š) w ³ ( t t š , ) š, y w» w. 3)» x ƒ : x t ( Áš, ks, qp,,, k, š, É, k, e ) w» x y»k t w w ƒ v w. š x w w ƒ» š» x w» mw xw ù» ˆ w. ks x ƒ ƒ w. y xw» w w w ƒ ƒ w». (4) t t» : t y t t» ƒ ˆ v w.» v w ù xw ù w v w yƒ», y t»» m mw w. t» w» y w t w t» y v wš n wš œ w. (5) t xƒ w y : t» xƒ w, xƒ w w. xƒ ƒ v w, t» w t w x» ƒ. y d š w šw w. x t» w w ü ü»xƒt» x mƒ v w, t» y w t w» w w w š w t» w ü t xƒ ü»xƒt w» x ƒ v w šw w., t ƒ p»» t validation ü q ƒ w» t ù xƒwš w Á z ³ w ƒ w., Áš t, p š w ³ œ, ü t xƒ w sw w 6 x œ. e w» Á z ƒ v w ù w» x e t ù. yd š w, t w ü» w xƒ w» w mƒ v w. (6) t z y : t ³ t p x š. t d, ü t 3» š 1 2z z šw z ƒ š ù, t w t ƒ ƒ w y», t z w xƒ eƒ v w. w t ³ w z ƒ ƒ w. (7) x w sƒ : t q ƒ t w ù. y š w ù xw p w t sƒ mw t ƒ w t w. (8) : t š d š, t w t» š wš, w t y mw w w v ƒ. (9) y : t w p z w ü t y w. (10) : t, w

8 130 Kor. J. Clin. Pharm., Vol. 16, No. 2, 2006 œw l x. t 1 w Áš (, j,, ) z p w œ w ƒ, t 2 3 t w w w l ƒ v w., t l w Á wš, w š w y y, ƒ t» w š t k š y w. wr, w ù t w ù ( : ) w š wš, k w eƒ l(poison center)ƒ š t v w l ƒ w. š t ƒ š š, t w š ƒ œs z š. t xƒ z t w ³ w š w ƒ y q šƒ t š q w ³ ƒ. w š t w, q z t t» w w š. ù, t t»» z xƒ w y ƒ v wš, w xw t xƒ wš y w z., w t w w» w š, šwš, l w z. w» wš x t t sƒw, mw ƒ. w, t p š z xƒ», w» z : 1) x mw š ƒ w š, 2)» t t t z w, 3) w xƒ» w t w w t t, 4) w ƒ ƒ w š ƒ w q wš w w» w t l k mwš l w š ƒ t t w w,. š x 1. t t w xz 2. ( mohw.go.kr/index.jsp) t t ( kfda. go.kr) Over-The-Counter. US FDA Center for Drug Evaluation and Research htm2005.8) 5. Cosmetics. US FDA Center for Food Safety and Applied Nutrition ( Dietary Supplements. US FDA Center for Food Safety and Applied Nutrition ( html) Medical Device. US FDA Center for Devices and Radiological Health ( Pesticides. US Environmental Protection Agency (

16(2)-7(p ).fm

16(2)-7(p ).fm w wz 16«2y Kor. J. Clin. Pharm., Vol. 16, No. 2. 2006 ü t xy y w tœ ½ BÁ x BC B y w w w C y w w w Current Status and Expectations of Orphan Drugs in Korea -In point of supplying medicines for the rare