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인허가규정문서 정보 :: 국가, 제제, 개발단계, 제목, 제·개정일
국가 제제 개발단계 제목 제·개정일
ICH 바이오의약품 일반 품목허가 BIOMARKERS RELATED TO DRUG OR BIOTECHNOLOGY PRODUCT DEVELOPMENT: CONTEXT, STRUCTURE AND FORMAT OF QUALIFICATION SUBMISSIONS E16
ICH 바이오의약품 일반 비임상 BRACKETING AND MATRIXING DESIGNS FOR STABILITY TESTING OF NEW DRUG SUBSTANCES AND PRODUCTS Q1D
ICH 바이오의약품 일반 임상 CHOICE OF CONTROL GROUP AND RELATED ISSUES IN CLINICAL TRIALS E10
ICH 바이오의약품 일반 임상 CLINICAL SAFETY DATA MANAGEMENT: DEFINITIONS AND STANDARDS FOR EXPEDITED REPORTING E2A
ICH 바이오의약품 일반 GMP Comparability of Biotechnological/Biological Products Subject to Changes in their Manufacturing Process Q5E
ICH 바이오의약품 일반 품목허가 DEFINITIONS FOR GENOMIC BIOMARKERS, PHARMACOGENOMICS, PHARMACOGENETICS, GENOMIC DATA AND SAMPLE CODING CATEGORIES E15
ICH 바이오의약품 일반 비임상,임상 DEVELOPMENT SAFETY UPDATE REPORT E2F
ICH 바이오의약품 일반 비임상 DOSE SELECTION FOR CARCINOGENICITY STUDIES OF PHARMACEUTICALS S1C (R2)
ICH 바이오의약품 일반 품목허가 DOSE-RESPONSE INFORMATION TO SUPPORT DRUG REGISTRATION E4
ICH 기타 비임상 DURATION OF CHRONIC TOXICITY TESTING IN ANIMALS (RODENT AND NON RODENT TOXICITY TESTING) S4

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