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.
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HA Controlled Vocabulary
Controlled Vocabulary / Code System Name as defoined by the Health Authority
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Term
Term Description as defined by the Health Authority
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Code
Code, if any, associated with the term by the Health Authority
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Agency
Name of the issuing Health Authority (abbreviation) that maintains the term and code
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Status
Current status of the Term usage as defined by the Health Authority (e.g., Current, Retired, Deprecated)
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|---|---|---|---|---|
| EU Context of Use | M1.9 Information Relating to Clinical Trials |
100000164057
|
EMA | Active |
| US Context of Use | m1.9.1 request for waiver of pediatric studies |
us_1.9.1
|
FDA | — |
| US Context of Use | m1.9.2 request for deferral of pediatric studies |
us_1.9.2
|
FDA | — |
| US Context of Use | m1.9.3 request for pediatric exclusivity determination |
us_1.9.3
|
FDA | — |
| US Context of Use | m1.9.4 proposed pediatric study request and amendments |
us_1.9.4
|
FDA | — |
| US Context of Use | m1.9.6 other correspondence regarding pediatric exclusivity or study plans |
us_1.9.6
|
FDA | — |
| EU Context of Use | M1.A Additional Data |
100000164060
|
EMA | Active |
| EU Context of Use | M1.R Responses |
100000164059
|
EMA | Active |
| ICH Context of Use | m2 common technical document summaries |
ich_2
|
ICH | Active |
| ICH Context of Use | m2.2 introduction |
ich_2.2
|
ICH | Active |
| ICH Context of Use | m2.3 quality overall summary |
ich_2.3
|
ICH | Active |
| ICH Context of Use | m2.3.a.1 facilities and equipment |
ich_2.3.a.1
|
ICH | Active |
| ICH Context of Use | m2.3.a.2 adventitious agents safety evaluation |
ich_2.3.a.2
|
ICH | Active |
| ICH Context of Use | m2.3.a.3 excipients |
ich_2.3.a.3
|
ICH | Active |
| ICH Context of Use | m2.3.i introduction |
ich_2.3.i
|
ICH | Active |
| ICH Context of Use | m2.3.p drug product |
ich_2.3.p
|
ICH | Active |
| ICH Context of Use | m2.3.r regional information |
ich_2.3.r
|
ICH | Active |
| ICH Context of Use | m2.3.s drug substance |
ich_2.3.s
|
ICH | Active |
| ICH Context of Use | m2.4 nonclinical overview |
ich_2.4
|
ICH | Active |
| ICH Context of Use | m2.5 clinical overview |
ich_2.5
|
ICH | Active |
| ICH Context of Use | m2.6.1 introduction |
ich_2.6.1
|
ICH | Active |
| ICH Context of Use | m2.6.2 pharmacology written summary |
ich_2.6.2
|
ICH | Active |
| ICH Context of Use | m2.6.3 pharmacology tabulated summary |
ich_2.6.3
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ICH | Active |
| ICH Context of Use | m2.6.4 pharmacokinetics written summary |
ich_2.6.4
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ICH | Active |
| ICH Context of Use | m2.6.5 pharmacokinetics tabulated summary |
ich_2.6.5
|
ICH | Active |
Showing 226–250 of 380 terms . Data sourced from public health authority publications and updated periodically.