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.
| 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.