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Content headings from ICH M4(R4). Module 1 is region-specific. Detailed subsections are grouped under their parent headings.
M1Regional administrative and prescribing information
M2CTD summaries
2.2CTD introduction
2.3Quality overall summary
2.4Nonclinical overview
2.5Clinical overview
2.6Nonclinical written and tabulated summaries
2.6.1Introduction
2.6.2Pharmacology written summary
2.6.3Pharmacology tabulated summary
2.6.4Pharmacokinetics written summary
2.6.5Pharmacokinetics tabulated summary
2.6.6Toxicology written summary
2.6.7Toxicology tabulated summary
2.7Clinical summary
2.7.1Biopharmaceutic studies and associated analytical methods
2.7.2Clinical pharmacology studies
2.7.3Clinical efficacy
2.7.4Clinical safety
2.7.5Literature references
2.7.6Synopses of individual studies
M3Quality
3.2Body of data
3.2.SDrug substance
3.2.S.1General information
3.2.S.2Manufacture
3.2.S.3Characterisation
3.2.S.4Control of drug substance
3.2.S.5Reference standards or materials
3.2.S.6Container closure system
3.2.S.7Stability
3.2.PDrug product
3.2.P.1Description and composition
3.2.P.2Pharmaceutical development
3.2.P.3Manufacture
3.2.P.4Control of excipients
3.2.P.5Control of drug product
3.2.P.6Reference standards or materials
3.2.P.7Container closure system
3.2.P.8Stability
3.2.AAppendices
3.2.A.1Facilities and equipment
3.2.A.2Adventitious agents safety evaluation
3.2.A.3Excipients
3.2.RRegional information
3.3Literature references
M4Nonclinical study reports
4.2Study reports
4.2.1Pharmacology
4.2.1.1Primary pharmacodynamics
4.2.1.2Secondary pharmacodynamics
4.2.1.3Safety pharmacology
4.2.1.4Pharmacodynamic drug interactions
4.2.2Pharmacokinetics
4.2.2.1Analytical methods and validation reports
4.2.2.2Absorption
4.2.2.3Distribution
4.2.2.4Metabolism
4.2.2.5Excretion
4.2.2.6Pharmacokinetic drug interactions
4.2.2.7Other pharmacokinetic studies
4.2.3Toxicology
4.2.3.1Single-dose toxicity
4.2.3.2Repeat-dose toxicity
4.2.3.3Genotoxicity
4.2.3.4Carcinogenicity
4.2.3.5Reproductive and developmental toxicity
4.2.3.6Local tolerance
4.2.3.7Other toxicity studies
4.3Literature references
M5Clinical study reports
5.2Tabular listing of all clinical studies
5.3Clinical study reports
5.3.1Biopharmaceutic studies
5.3.2Studies using human biomaterials
5.3.3Human pharmacokinetic studies
5.3.4Human pharmacodynamic studies
5.3.5Efficacy and safety studies
5.3.6Postmarketing experience
5.3.7Case report forms and individual patient listings
5.4Literature references