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← eCTD Controlled Vocabularies

Context of Use

Links a CTD table-of-contents heading to the document(s) placed under it. Module 1 codes are regionally defined; Modules 2-5 are ICH-defined.

eCTD 4.0 Context of Use 146 terms
All agencies EMA FDA ICH SwissMedic
Term Code Agency Status
current active ICH Active
m2 common technical document summaries ich_2 ICH Active
m2.2 introduction ich_2.2 ICH Active
m2.3 quality overall summary ich_2.3 ICH Active
m2.3.a.1 facilities and equipment ich_2.3.a.1 ICH Active
m2.3.a.2 adventitious agents safety evaluation ich_2.3.a.2 ICH Active
m2.3.a.3 excipients ich_2.3.a.3 ICH Active
m2.3.i introduction ich_2.3.i ICH Active
m2.3.p drug product ich_2.3.p ICH Active
m2.3.r regional information ich_2.3.r ICH Active
m2.3.s drug substance ich_2.3.s ICH Active
m2.4 nonclinical overview ich_2.4 ICH Active
m2.5 clinical overview ich_2.5 ICH Active
m2.6.1 introduction ich_2.6.1 ICH Active
m2.6.2 pharmacology written summary ich_2.6.2 ICH Active
m2.6.3 pharmacology tabulated summary ich_2.6.3 ICH Active
m2.6.4 pharmacokinetics written summary ich_2.6.4 ICH Active
m2.6.5 pharmacokinetics tabulated summary ich_2.6.5 ICH Active
m2.6.6 toxicology written summary ich_2.6.6 ICH Active
m2.6.7 toxicology tabulated summary ich_2.6.7 ICH Active
m2.7.1 summary of biopharmaceutic studies and associated analytical methods ich_2.7.1 ICH Active
m2.7.2 summary of clinical pharmacology studies ich_2.7.2 ICH Active
m2.7.3 summary of clinical efficacy ich_2.7.3 ICH Active
m2.7.4 summary of clinical safety ich_2.7.4 ICH Active
m2.7.5 literature references ich_2.7.5 ICH Active
m2.7.6 synopses of individual studies ich_2.7.6 ICH Active
m3.2.a appendices ich_3.2.a ICH Active
m3.2.a.1 facilities and equipment ich_3.2.a.1 ICH Active
m3.2.a.2 adventitious agents safety evaluation ich_3.2.a.2 ICH Active
m3.2.a.3 excipients ich_3.2.a.3 ICH Active
m3.2.p drug product ich_3.2.p ICH Active
m3.2.p.1 description and composition of the drug product ich_3.2.p.1 ICH Active
m3.2.p.2 pharmaceutical development ich_3.2.p.2 ICH Active
m3.2.p.2.1 components of the drug product ich_3.2.p.2.1 ICH Active
m3.2.p.2.2 drug product ich_3.2.p.2.2 ICH Active
m3.2.p.2.3 manufacturing process development ich_3.2.p.2.3 ICH Active
m3.2.p.2.4 container closure system ich_3.2.p.2.4 ICH Active
m3.2.p.2.5 microbiological attributes ich_3.2.p.2.5 ICH Active
m3.2.p.2.6 compatibility ich_3.2.p.2.6 ICH Active
m3.2.p.3 manufacture ich_3.2.p.3 ICH Active
m3.2.p.3.1 manufacturer(s) ich_3.2.p.3.1 ICH Active
m3.2.p.3.2 batch formula ich_3.2.p.3.2 ICH Active
m3.2.p.3.3 description of manufacturing process and process controls ich_3.2.p.3.3 ICH Active
m3.2.p.3.4 controls of critical steps and intermediates ich_3.2.p.3.4 ICH Active
m3.2.p.3.5 process validation and/or evaluation ich_3.2.p.3.5 ICH Active
m3.2.p.4 control of excipients ich_3.2.p.4 ICH Active
m3.2.p.4.1 specifications ich_3.2.p.4.1 ICH Active
m3.2.p.4.2 analytical procedures ich_3.2.p.4.2 ICH Active
m3.2.p.4.3 validation of analytical procedures ich_3.2.p.4.3 ICH Active
m3.2.p.4.4 justification of specifications ich_3.2.p.4.4 ICH Active
m3.2.p.4.5 excipients of human or animal origin ich_3.2.p.4.5 ICH Active
m3.2.p.4.6 novel excipients ich_3.2.p.4.6 ICH Active
m3.2.p.5 control of drug product ich_3.2.p.5 ICH Active
m3.2.p.5.1 specification(s) ich_3.2.p.5.1 ICH Active
m3.2.p.5.2 analytical procedures ich_3.2.p.5.2 ICH Active
m3.2.p.5.3 validation of analytical procedures ich_3.2.p.5.3 ICH Active
m3.2.p.5.4 batch analyses ich_3.2.p.5.4 ICH Active
m3.2.p.5.5 characterisation of impurities ich_3.2.p.5.5 ICH Active
m3.2.p.5.6 justification of specifications ich_3.2.p.5.6 ICH Active
m3.2.p.6 reference standards or materials ich_3.2.p.6 ICH Active
m3.2.p.7 container closure system ich_3.2.p.7 ICH Active
m3.2.p.8 stability ich_3.2.p.8 ICH Active
m3.2.p.8.1 stability summary and conclusion ich_3.2.p.8.1 ICH Active
m3.2.p.8.2 post-approval stability protocol and stability commitment ich_3.2.p.8.2 ICH Active
m3.2.p.8.3 stability data ich_3.2.p.8.3 ICH Active
m3.2 r regional information ich_3.2.r ICH Active
m3.2.s drug substance ich_3.2.s ICH Active
m3.2.s.1 general information ich_3.2.s.1 ICH Active
m3.2.s.2 manufacture ich_3.2.s.2 ICH Active
m3.2.s.2.1 manufacturer(s) ich_3.2.s.2.1 ICH Active
m3.2.s.2.2 description of manufacturing process and process controls ich_3.2.s.2.2 ICH Active
m3.2.s.2.3 control of materials ich_3.2.s.2.3 ICH Active
m3.2.s.2.4 controls of critical steps and intermediates ich_3.2.s.2.4 ICH Active
m3.2.s.2.5 process validation and/or evaluation ich_3.2.s.2.5 ICH Active
m3.2.s.2.6 manufacturing process development ich_3.2.s.2.6 ICH Active
m3.2.s.3 characterisation ich_3.2.s.3 ICH Active
m3.2.s.3.1 elucidation of structure and other characteristics ich_3.2.s.3.1 ICH Active
m3.2.s.3.2 impurities ich_3.2.s.3.2 ICH Active
m3.2.s.4 control of drug substance ich_3.2.s.4 ICH Active
m3.2.s.4.1 specification ich_3.2.s.4.1 ICH Active
m3.2.s.4.2 analytical procedures ich_3.2.s.4.2 ICH Active
m3.2.s.4.3 validation of analytical procedures ich_3.2.s.4.3 ICH Active
m3.2.s.4.4 batch analyses ich_3.2.s.4.4 ICH Active
m3.2.s.4.5 justification of specification ich_3.2.s.4.5 ICH Active
m3.2.s.5 reference standards or materials ich_3.2.s.5 ICH Active
m3.2.s.6 container closure system ich_3.2.s.6 ICH Active
m3.2.s.7 stability ich_3.2.s.7 ICH Active
m3.2.s.7.1 stability summary and conclusions ich_3.2.s.7.1 ICH Active
m3.2.s.7.2 post-approval stability protocol and stability commitment ich_3.2.s.7.2 ICH Active
m3.2.s.7.3 stability data ich_3.2.s.7.3 ICH Active
m3.3 literature references ich_3.3 ICH Active
m4.2.1.1 primary pharmacodynamics ich_4.2.1.1 ICH Active
m4.2.1.2 secondary pharmacodynamics ich_4.2.1.2 ICH Active
m4.2.1.3 safety pharmacology ich_4.2.1.3 ICH Active
m4.2.1.4 pharmacodynamic drug interactions ich_4.2.1.4 ICH Active
m4.2.2.1 analytical methods and validation reports ich_4.2.2.1 ICH Active
m4.2.2 2 absorption ich_4.2.2.2 ICH Active
m4.2.2.3 distribution ich_4.2.2.3 ICH Active
m4.2.2.4 metabolism ich_4.2.2.4 ICH Active
m4.2.2.5 excretion ich_4.2.2.5 ICH Active
m4.2.2.6 pharmacokinetic drug interactions ich_4.2.2.6 ICH Active
m4.2.2.7 other pharmacokinetic studies ich_4.2.2.7 ICH Active
m4.2.3.1 single-dose toxicity ich_4.2.3.1 ICH Active
m4.2.3.2 repeat-dose toxicity ich_4.2.3.2 ICH Active
m4.2.3.3.1 in vitro ich_4.2.3.3.1 ICH Active
m4.2.3.3.2 in vivo ich_4.2.3.3.2 ICH Active
m4.2.3.4.1 long-term studies ich_4.2.3.4.1 ICH Active
m4.2.3.4.2 short or medium-term studies ich_4.2.3.4.2 ICH Active
m4.2.3.4.3 other studies ich_4.2.3.4.3 ICH Active
m4.2.3.5.1 fertility and early embryonic development ich_4.2.3.5.1 ICH Active
m4.2.3.5.2 embryofetal development ich_4.2.3.5.2 ICH Active
m4.2.3.5.3 prenatal and postnatal development, including maternal function ich_4.2.3.5.3 ICH Active
m4.2.3.5.4 studies in which the offspring juvenile animals are dosed and/or further evaluated ich_4.2.3.5.4 ICH Active
m4.2.3.6 local tolerance ich_4.2.3.6 ICH Active
m4.2.3.7.1 antigenicity ich_4.2.3.7.1 ICH Active
m4.2.3.7.2 immunotoxicity ich_4.2.3.7.2 ICH Active
m4.2.3.7.3 mechanistic studies ich_4.2.3.7.3 ICH Active
m4.2.3.7.4 dependence ich_4.2.3.7.4 ICH Active
m4.2.3.7.5 metabolites ich_4.2.3.7.5 ICH Active
m4.2.3.7.6 impurities ich_4.2.3.7.6 ICH Active
m4.2.3.7.7 other ich_4.2.3.7.7 ICH Active
m4.3 literature references ich_4.3 ICH Active
m5.2 tabular listing of all clinical studies ich_5.2 ICH Active
m5.3.1.1 bioavailability study reports ich_5.3.1.1 ICH Active
m5.3.1.2 comparative ba and bioequivalence study reports ich_5.3.1.2 ICH Active
m5.3.1.3 in vitro in vivo correlation study reports ich_5.3.1.3 ICH Active
m5.3.1.4 reports of bioanalytical and analytical methods for human studies ich_5.3.1.4 ICH Active
m5.3.2.1 plasma protein binding study reports ich_5.3.2.1 ICH Active
m5.3.2.2 reports of hepatic metabolism and drug interaction studies ich_5.3.2.2 ICH Active
m5.3.2.3 reports of studies using other human biomaterials ich_5.3.2.3 ICH Active
m5.3.3.1 healthy subject pk and initial tolerability study reports ich_5.3.3.1 ICH Active
m5.3.3.2 patient pk and initial tolerability study reports ich_5.3.3.2 ICH Active
m5.3.3 3 intrinsic factor pk study reports ich_5.3.3.3 ICH Active
m5.3.3.4 extrinsic factor pk study reports ich_5.3.3.4 ICH Active
m5.3.3.5 population pk study reports ich_5.3.3.5 ICH Active
m5.3.4.1 healthy subject pd and pk/pd study reports ich_5.3.4.1 ICH Active
m5.3.4.2 patient pd and pk/pd study reports ich_5.3.4.2 ICH Active
m5.3.5.1 study reports of controlled clinical studies pertinent to the claimed indication ich_5.3.5.1 ICH Active
m5.3.5.2 study reports of uncontrolled clinical studies ich_5.3.5.2 ICH Active
m5.3.5.3 reports of analyses of data from more than one study ich_5.3.5.3 ICH Active
m5.3.5.4 other study reports ich_5.3.5.4 ICH Active
m5.3.6 reports of postmarketing experience ich_5.3.6 ICH Active
m5.3.7 case report forms and individual patient listings ich_5.3.7 ICH Active
m5.4 literature references ich_5.4 ICH Active
replaced obsolete ICH Active
no longer relevant suspended ICH Active

146 terms shown for ICH. Data sourced from public health authority publications and updated periodically.