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장 일 무 ( 교수 ) 제약학과 changim@snu.ac.kr intellectual.co.kr

의약품 정보과학 New Drug Development and Registration for Pharmaceutical Industry 신약 등록 절차와 CRO (Contract Research Organization). 장 일 무 ( 교수 ) 제약학과 changim@snu.ac.kr www.intellectual.co.kr. 목표 및 내용. 의약품의 제조허가를 위한 제반 규정의 이해 의약품 ( 합성 , 미생물 - 항생제 , 천연약물 , 생물약품 , 동물약품 등 )

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장 일 무 ( 교수 ) 제약학과 changim@snu.ac.kr intellectual.co.kr

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  1. 의약품 정보과학New Drug Development and Registration for Pharmaceutical Industry신약 등록 절차와 CRO (Contract Research Organization) 장 일 무 (교수) 제약학과 changim@snu.ac.kr www.intellectual.co.kr

  2. 목표 및 내용 • 의약품의 제조허가를 위한 제반 규정의 이해 • 의약품 (합성, 미생물-항생제, 천연약물, 생물약품, 동물약품 등) • 기능성 식품, 기능성화장품 제조허가를 위한 규정 • 허가 규정에 따른 문서 작성 능력 제고 • CRO (Contract Research Organization) 역활 • 각종 시험 자료의 분석 및 평가 능력 • 각종 문헌 자료의 수집, 분석평가 및 축적 • 자료의 Database 화 및 Documentation능력

  3. Research & Development in Pharmacy • Drugs • Prevention of diseases (예방) • Diagnosis (진단) • Treatment (mitigate) and cure (치료) • Sources of Drug Substances • Synthetic • Botanical/Herbal (plants, animals, minerals) • Microbial • Biotechnological (genome therapy)

  4. Basic Elements of Drugs • Quality (품질) • CMC (Chemistry/Manufacturing/Control) • Chemistry: 분석법 • Manufacturing: Good Manufacturing Practice • Safety (안전성) • Pre-clinic (비/전임상), (Good Laboratory Practice); Toxicology tests (general and special)(animals/in vitro) • Clinical trials (Phase 1~3), Good Clinical Practice • Efficacy (유효성/약효/효능) • ADME (Absorption, Distribution, Metabolism, Excretion) • PD (pharmacodynacmics) and PK (pharmacokinetics)

  5. Differences between R & D • Research on (New) Drugs • New findings on a substance • New substance • New activities • Academic studies • Production of intellectual properties • New substance patent, New use-bound patent • Development • based on research results • apply investigational new drugs (IND) by regulations (CMC, GLP, GCP) • New Drug Application (NDA)

  6. New Drug R & D • synthetic • microbial • pharmacognosy • analysis • Research • New Substances • New Use (Effects) • pharmacology • toxicology • GMP • analysis • quality control • Phamraceutics Contract Research Organization • GLP & GCP • ADME PD, PK • Development • Dosage/formulation (CMC) • Safety (preclinic/clinical trials) • Efficacy(preclinic/clinical trials)

  7. 법규와 국제협약-1 The Constitution (헌법)The basic law that prescribes matters concerning rights and duties of citizens and the structure of government. Acts (법)The statutes which prescribe matters concerning rights and obligations of citizens. Treaties (조약)The formally signed and ratified agreements between two or more nations. They have the same legal effect as domestic laws.

  8. 법규와 국제협약-2 Presidential Decrees (시행령)The subordinate statutes which prescribe matters delegated to the president by act with the scope specifically defined, and also matters necessary to enforce the act concerned. Ordinances of the Prime Minister/Ministerial Ordinances(총리 및 장관 훈령)The subordinate statutes which prescribe matters delegated to the Prime Minister or the head of each government Ministry, including matters within the jurisdiction of the ministry. Municipal Ordinances/Municipal Rules (지자체 조례)The subordinate local statutes which prescribe matters concerning local affairs within the purview of Acts and subordinate statutes.

  9. 법규와 국제협약-3 Notice (지침/예규) Administrative rules prepared by a governmental authority. Easily revised by the authorities. Guideline (가이드라인) Recommended and administrative directions prepared by a governmental authorities and/or international organizations. Not necessarily followed. For mutual benefits, recommended to follow. However, when participate the organization, and agreement made to follow, it is compulsory to keep the guide-lines among countries. (CITES, biodiversity, WTO, WIPO, etc)

  10. 문헌자료(정보) 분류? • 정보발생에 따른 분류 (발생시기) • 1차 정보; Primary sources • 최초 발생 정보 • 학회발표, 학술지논문, 초록,속보,뉴스, 관보, 보고서, 개인사신 • 2차 정보;Secondary sources • 1차 정보를 편집, 가공한 정보 • 분석평가 정보도 포함 • 종설 (Review), 단행본, 핸드북

  11. 정보의 이용형태 • 정보기술(Information Technology)의 발달 • 데이터베이스 (Database) 구축을 통한 • 컨텐츠 (Contents) 화 추세 • 각각의 전문 컨텐츠가 종합된 전문 컨텐츠 Portal로 발전 • 접근 방법은 ? • Bibliograph (書誌사항), 초록, 목차 • Directory (소장목록안내) • Union Catalogue (종합목록)

  12. 온라인 데이터베이스의 통합화 • 대형 관문포탈로 변신 추세; Portal Gateway • Thomson • STN • Embase 등 • UBM 등 • 향후 IT 컨텐츠 산업의 변화 경향의 하나로 인식 • 전문영역 DB + Buisiness (Industry) + Entertainment 가 통합된 대형 포탈의 출현 • Ubiquitous

  13. www.nlm.nih.gov

  14. NLM databases

  15. Chemical Abstract Search (Am.Chem.Soc.) www.cas.org

  16. www.stnweb.cas.org www.stnweb-japan.cas.org www.stn.intenational.de

  17. U.S. FDA 규정, 의약품, 화장품.의료기기 등록 현황 등 http://stneasy.cas.org/dbss/help.DIOGENES.html

  18. //library.dialog.com/bluesheets/html/bl0034.html 과거 Dialog가 Thomson으로 통합

  19. www.isinet.com BIOSIS, SCISEARCH, DIALOG 등 통합

  20. //toxnet.nlm.nih.gov

  21. www.jst.go.jp

  22. www.nii.ac.jp/els/els-j.html

  23. www.embase.com Elsevier 출판사

  24. KIMS Online (메디메디아 Co.) www.kimsonline.co.kr

  25. TradiMed 전통동양약물데이터베이스 www.tradimed.com

  26. 의약품 관련 등록기관Regulatory Agencies & Related Organization • 식품의약품안전청(KFDA): 식품,의약품, 화장품, 의료기기에 등록업무 • US FDA: 미국 • NIHS (National Institute of Health Science); 일본 • SFDA (State Food & Drugs Administration); 중국 • TGA (Therapeutic Goods Administration); 호주 • EMEA (European Agency for the Evaluation of Medicinal Products); EU (www.emea.eu.int ) • HPFB (Health Products and Food Branch) (Health Canada); 캐나다www.hc-sc.gc.ca/hpfb-dgpsa/inspectorate/ich_e.html • Therapeutic Products • Natural Health Products (천연약물부분 신설) • Food • Biologics and Genetics

  27. Regulatory Affairs 법: Law 시행령: Presidential ordinance 시행세칙/예규: Detailed enforcement regulations 훈령: Ministerial (government) order 고시: Notice (FDA’s Commissioner) 식약청 고시 가이드라인; Guideline • 의약품(Drug) 1) 약사법 (藥事法); Pharmaceutical Affairs Law • - 천연물신약연구개발 촉진법 • 동 시행령 및 고시 • 건강기능성 식품법(Functional Food, Nutraceuticals, Dietary Supplement) • 화장품법 (Cosmetics) • 기능성화장품 (Functional cosmetics) • Drugs ? • 질병의 진단, 예방, 치료 • 안전성, 유효성 확보 • -효능, 부작용 표시 • 건강기능성식품 • 완하, 보조 • 치료효과를 표시 못함 천연물 또는 한약 ? vs

  28. 약 NDA IND Contract Laboratory Clinical Trial Center 임상시험 Clinical (GCP) Phase1, 2, 3 비임상시험 Non-clinical (GLP) Substance New Drug Application Investigational New Drug 물질특허 (New Substances): 신 물질 용도특허 (New Use-bound): 신 약효 조성물특허 (New Composition: 신 복합제제 등록-Registration 제조-Manufacturing (GMP) 지적재산권-산업재산권 Intellectual Property-Patents GLP; Good Laboratory Practice GCP; Good Clinical Practice GMP; Good Manufacturing Practice GAP; Good Agricultural Practice (약초재배)

  29. www.kfda.go.kr

  30. U.S.FDA www.fda.gov

  31. Health Products and Food Branch www.hc-sc.gc.ca/hpfb-dgpsa/inspectorate/ich_e.html

  32. European Medicines Agency www.emea.eu.int

  33. www.nihs.go.jp

  34. Therapeutic Goods Administration www.tga.gov.au

  35. State Food and Drug Administration www.sda.gov.cn

  36. The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) www.ich.org 정식회원: 미, 일본, EU

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