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1 (PatentOffice) (SamuelLee) 1796 (BiliousPill) (Samuel H.P.Lee) (Bilious Pills) (SamuelLee) (SamuelH.P.Lee) (BiliousPills) (SamuelLee) (caveatemptor) (USP) (U.S. Pharmacopeia USP) ( ) USP ( ) USP USP 1/17

2 (American MedicalAssociation AMA) (American Pharmaceutical Association APhA) (National Formulary) USP USP. FDA ( 30%) 19 (Journal of theamerican Medical Association) (Drug ImportationAct) USP 1862 (Chemical Division U.S.Department of Agriculture Bureau) (FDA) (HarveyW.Wiley) Paddock bill (AmericanPharmaceutical Association) 2/17

3 (Pure Food and Drugs Act PFDA) Wiley Wiley (adulterated) / (U.S.Pharmacopoeia/National For-mulary) USP USP ( USP ) (misbranded) (alcohol) (morphine) (opium) (cocaine) (heroin) ( alpha betaeucaine) (chloroform) (cannabis) (chloralhydrate) (Food and Drug Administration FDA) FDA Sherley (Sherley Amendment) 20 6 FDA 1906 Tugwell Rexford 1933 Tugwell Copeland FDA 1935 Massengil /17

4 Elixir Sulfanilamide 107, 1906 Elixir Sulfanil-amide 11 Elixir Sul-fanilamide Massengill (Food,Drugs,and Cosmetic Act FDCA) FDA FDA FDA (New Drug Applic-ation NDA) NDA FDA NDA 60 FDA Sherley FDA (misbr-anded) FDA (sulfas) FDA. FDA 1906 Tugwell Rexford 1933 Tugwell Copeland FDA 1935 Massengil /17

5 Elixir Sulfanilamide 107, 1906 Elixir Sulfanil-amide 11 Elixir Sul-fanilamide Massengill (Food,Drugs,and Cosmetic Act FDCA) FDA FDA FDA (New Drug Applic-ation NDA) NDA FDA NDA 60 FDA Sherley FDA (misbr-anded) FDA (sulfas) FDA. Kefauver-Harris Estes Kefauver 8% Kefauver (PMA) (AMA) 5/17

6 Richardson-Merrell 1957 (thalidomide) 1960 Kevadon FDA (Frances Kelsey) thalidomide (thalidomide) Richardson-Merrell FDA thalidomide Richardson-Merrell thalidomide Kefauver-Harris Kefauver Kefauver-Harris (Kefauver-Harris Amendments) FDA FDA Kefauver-Harris 60 FDA FDA FDA FDA (Investigational New Drug IND) Kefauver-Harris FDA 六. FDA FDA (Food and Drug Administration) FDA 160 FDA 6/17

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8 7) ) FDA FDA FDA sodium pentobarbital 9) FDA FDA FDA. FDA FDA (Orange Book) (Approved Drug Products with Therapeutic Equivalence Evaluations) FDA (PatentTrade markoffice) (Uruguay Rounds Agreements Act) (Drug Price Competition and Patent Term Restoration Act) 5 14 FDA 60 FDA FDA 8/17

9 FDA 1) (NCE) 5 FDA 5 5 FDA NCE 2) 3 ( ) FDA 3 3) (The Orphan Dru gact) 50% 7 4) ) (Drug Price Competition an dpatent Term Restoration Act) 180 FDA. FDA FDA FDA ( ) FDA FDA FDA FDA FDA FDA 1996 FDA (Operational and Administrative System for Import Support OASIS) FDA (Automated Commercial System ACS) 9/17

10 ACS FDA FDA FDA OASIS OASIS FDA FDA FDA FDA (API) FDA FDA FDA. FDA FDA (Notice of Detention and Hearing) ( ) FDA FDA (drug registration) (product listing) FDA FDA (Notice ofrefusal of Admission) GMP FDA (Detention Without Physical Examination DWPE) GMP GMP FDA 1961 Kefauver-Harris 1962 FDA 10/17

11 FDA FDA % 1984 FDA FDA 1984 (Drug Price Competition and Patent Term Restoration Act) Waxman-Hatch Act Orrin Hatch HenryW axman 505(j) FDA (NDA), (Bioequivelence) (Abbreviated New Drug Application ANDA) Hatch-Waxman Act FDA 1989 FDA FDA FDA FDA (Vitarin) FDA FDA 38 11/17

12 FDA FDA (Generic Drug Enforcement Act) FDA 306(d)(4) FDA FDA FDA FDA FDA FDA (Federal Register) FDA FDA FDA FDA (, ) FDA FDA FDA 1) 2) (Permissive Debarment) FDA 5 3) (mandatory debarment) (permissived ebarment) 10 4) FDA 5) FDA 6) FDA 90% 90% debarment. OTC 1906 (Pure Food and Drugs Act) 12/17

13 1938 (Food, Drug, and Cosmetic Act FDCA) FDA FDA (NDA) Grandfather 201(p) 1938 (NDA) FDA 1938 OTC FDA FDA OTC 1938 OTC OTC FDA OTC. OTC FDA FDA 1944 (OTC) FDA 1948 FDA (misbranded) FDA FDA 1951 Durham-Humphrey (Prescription Drug Amendment) Durham-Humphrey 1938 (prescription drugs) (OTC) :(1) 502(d) (2) 13/17

14 (3) (NDA) Durham-Humphrey OTC OTC OTC FDA Durham-Humphrey (Caution Federal law prohibits dispensing without prescription 1998 Rx Durham-Humphrey FDA OTC FDA 701(a) 1962 Kefauver FDA 1951 Durham-Humphrey FDA 1961 (thalidomide) Kefauver FDA FDA FDA 1966 (National Academy of Science) (National Research Council) FDA (Drug Efficacy Study Implementation DESI) DESI DESI. ( ) FDA FDA FDA (j) (recommended daily allowance RDA) FDA FDA FDA 1976 (Vitamins And Minerals Amendments) Proxmire FDA 14/17

15 Proxmire FDA (Food additives) 1958 (Food Additives Amendment) FDA FDA FDA FDA (1) (2) (3) (4) (5) FDA FDA FDA 1990 FDA FDA FDA FDA (Black Currant Oil) 1988 FDA (Black Currant Oil) Traco Traco Traco FDA (gelatin) (gelatin) FDA FDA (dietary supplement) FDA FDA (Nutrition Labeling and Education Act NLEA) NLEA (herbs or similar nutri-tional substances) FDA 15/17

16 NLEA FDA FDA FDA FDA FDA FDA 1992 (HealthFreedomAct) FDA FDA (Dietary Supplement Health and EducationAct DSHEA) DSHEA FDA DSHEA FDA DSHEA GMP DSHEA 六 FDA ) FDA 16/17

17 1. FDA FDA ( ) OTC (OTC drug monograph) (NDA) (ANDA) FDA FDA (NDA) OTC OTC FDA FDA FDA FDA 17/17

FDA FDA 7 IND FDA FDA DMF DMF DMF Regulatory Affairs

FDA FDA 7 IND FDA FDA DMF DMF DMF Regulatory Affairs CIP /. 2005.9 ISBN 7-5067 - 3227-0 Ⅰ. Ⅱ. Ⅲ.1 2 Ⅳ. 1R954 2D971.221 CIP 2004 086601 22 100088 010-62244206 www.mpsky.com.cn A4 30 1 866 14000 2005 9 1