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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|---|---|---|---|---|
| ICH Context of Use | m3.2.p.4.1 specifications |
ich_3.2.p.4.1
|
ICH | Active |
| ICH Context of Use | m3.2.p.4 control of excipients |
ich_3.2.p.4
|
ICH | Active |
| ICH Context of Use | m3.2.p.3.5 process validation and/or evaluation |
ich_3.2.p.3.5
|
ICH | Active |
| ICH Context of Use | m3.2.p.3.4 controls of critical steps and intermediates |
ich_3.2.p.3.4
|
ICH | Active |
| ICH Context of Use | m3.2.p.3.3 description of manufacturing process and process controls |
ich_3.2.p.3.3
|
ICH | Active |
| ICH Context of Use | m3.2.p.3.2 batch formula |
ich_3.2.p.3.2
|
ICH | Active |
| ICH Context of Use | m3.2.p.3.1 manufacturer(s) |
ich_3.2.p.3.1
|
ICH | Active |
| ICH Context of Use | m3.2.p.3 manufacture |
ich_3.2.p.3
|
ICH | Active |
| ICH Context of Use | m3.2.p.2.6 compatibility |
ich_3.2.p.2.6
|
ICH | Active |
| ICH Context of Use | m3.2.p.2.5 microbiological attributes |
ich_3.2.p.2.5
|
ICH | Active |
| ICH Context of Use | m3.2.p.2.4 container closure system |
ich_3.2.p.2.4
|
ICH | Active |
| ICH Context of Use | m3.2.p.2.3 manufacturing process development |
ich_3.2.p.2.3
|
ICH | Active |
| ICH Context of Use | m3.2.p.2.2 drug product |
ich_3.2.p.2.2
|
ICH | Active |
| ICH Context of Use | m3.2.p.2.1 components of the drug product |
ich_3.2.p.2.1
|
ICH | Active |
| ICH Context of Use | m3.2.p.2 pharmaceutical development |
ich_3.2.p.2
|
ICH | Active |
| ICH Context of Use | m3.2.p.1 description and composition of the drug product |
ich_3.2.p.1
|
ICH | Active |
| ICH Context of Use | m3.2.p drug product |
ich_3.2.p
|
ICH | Active |
| ICH Context of Use | m3.2.a.3 excipients |
ich_3.2.a.3
|
ICH | Active |
| ICH Context of Use | m3.2.a.2 adventitious agents safety evaluation |
ich_3.2.a.2
|
ICH | Active |
| ICH Context of Use | m3.2.a.1 facilities and equipment |
ich_3.2.a.1
|
ICH | Active |
| ICH Context of Use | m3.2.a appendices |
ich_3.2.a
|
ICH | Active |
| ICH Context of Use | m3.2 r regional information |
ich_3.2.r
|
ICH | Active |
| ICH Context of Use | m2.7.6 synopses of individual studies |
ich_2.7.6
|
ICH | Active |
| ICH Context of Use | m2.7.5 literature references |
ich_2.7.5
|
ICH | Active |
| ICH Context of Use | m2.7.4 summary of clinical safety |
ich_2.7.4
|
ICH | Active |
Showing 101–125 of 380 terms . Data sourced from public health authority publications and updated periodically.