의약품 정보과학 new drug development and registration for pharmaceutical industry 신약...
TRANSCRIPT
의약품 정보과학New Drug Development and Registration for
Pharmaceutical Industry
신약 등록 절차와 CRO (Contract Research Organization)
장 일 무 ( 교수 )제약학과
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 제고CRO (Contract Research Organization) 역활각종 시험 자료의 분석 및 평가 능력
• 각종 문헌 자료의 수집 , 분석평가 및 축적자료의 Database 화 및 Documentation 능력
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)
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); Tox
icology 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)
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)
New Drug R & D
ResearchNew SubstancesNew Use (Effects)
•synthetic•microbial•pharmacognosyanalysis
pharmacologytoxicology
DevelopmentDosage/formulation (CMC)
Safety (preclinic/clinical trials)Efficacy(preclinic/clinical trials)
•GMPanalysis
quality control•Phamraceutics
•GLP & GCP
ADME PD, PK
Contract Research Organization
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.
법규와 국제협약 -2Presidential 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.
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 agovernmental authorities and/or international organizations.Not necessarily followed. For mutual benefits, recommendedto 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)
문헌자료 ( 정보 ) 분류 ?
• 정보발생에 따른 분류 ( 발생시기 ) 1 차 정보 ; Primary sources
최초 발생 정보 학회발표 , 학술지논문 , 초록 , 속보 , 뉴스 , 관보 ,
보고서 , 개인사신2 차 정보 ;Secondary sources
1 차 정보를 편집 , 가공한 정보 분석평가 정보도 포함 종설 (Review), 단행본 , 핸드북
정보의 이용형태• 정보기술 (Information Technology) 의 발달
데이터베이스 (Database) 구축을 통한 컨텐츠 (Contents) 화 추세각각의 전문 컨텐츠가 종합된 전문 컨텐츠 P
ortal 로 발전 접근 방법은 ?
Bibliograph ( 書誌사항 ), 초록 , 목차 Directory ( 소장목록안내 ) Union Catalogue ( 종합목록 )
온라인 데이터베이스의 통합화
• 대형 관문포탈로 변신 추세 ; Portal GatewayThomsonSTNEmbase 등 UBM 등
• 향후 IT 컨텐츠 산업의 변화 경향의 하나로 인식전문영역 DB + Buisiness (Industry) + Entertainment 가 통합된 대형 포탈의 출현Ubiquitous
www.nlm.nih.gov
NLM databases
Chemical Abstract Search (Am.Chem.Soc.)www.cas.org
www.stn.intenational.de
www.stnweb-japan.cas.orgwww.stnweb.cas.org
http://stneasy.cas.org/dbss/help.DIOGENES.html
U.S. FDA 규정 , 의약품 , 화장품 . 의료기기 등록 현황 등
//library.dialog.com/bluesheets/html/bl0034.html
과거 Dialog 가 Thomson 으로 통합
www.isinet.com BIOSIS, SCISEARCH, DIALOG 등 통합
//toxnet.nlm.nih.gov
www.jst.go.jp
www.nii.ac.jp/els/els-j.html
www.embase.com Elsevier 출판사
KIMS Online ( 메디메디아 Co.)www.kimsonline.co.kr
TradiMed전통동양약물데이터베이스
www.tradimed.com
의약품 관련 등록기관 Regulatory 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); E
U (www.emea.eu.int )
• HPFB (Health Products and Food Branch) (Health Canada); 캐나다 www.hc-sc.gc.ca/hpfb-dgpsa/inspectorate/ich_e.html– Therapeutic Products
– Natural Health Products ( 천연약물부분 신설 )
– Food
– Biologics and Genetics
Regulatory Affairs
법 : Law시행령 : Presidential ordinance시행세칙 / 예규 : Detailed enforcement regulations훈령 : Ministerial (government) order고시 : Notice (FDA’s Commissioner) 식약청 고시가이드라인 ; 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 , 예방• 치료효과를 표시 못함•USFDA 효능을 보장 안함 .•KFDA 등록허가제도로 미국과 달리 효능 보장
vs천연물 또는 한약 ?
약
Substance
물질특허 (New Substances): 신 물질용도특허 (New Use-bound): 신 약효조성물특허 (New Composition: 신 복합제제
지적재산권 - 산업재산권Intellectual Property-Patents
비임상시험
Non-clinical (GLP)
임상시험Clinical (GCP)Phase1, 2, 3
IND NDA
Investigational New Drug New Drug Application
Contract Laboratory Clinical Trial Center
등록 -Registration
제조 -Manufacturing(GMP)
GLP; Good Laboratory PracticeGCP; Good Clinical PracticeGMP; Good Manufacturing PracticeGAP; Good Agricultural Practice ( 약초재배 )
www.kfda.go.kr
www.fda.govU.S.FDA
Health Products and Food Branch
www.hc-sc.gc.ca/hpfb-dgpsa/inspectorate/ich_e.html
www.emea.eu.intEuropean Medicines Agency
www.nihs.go.jp
www.tga.gov.au
Therapeutic Goods Administration
State Food and Drug Administrationwww.sda.gov.cn
The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)
www.ich.org 정식회원 : 미 , 일본 , EU