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.s.2 manufacture |
ich_3.2.s.2
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ICH | Active |
| ICH Context of Use | m3.2.s.2.1 manufacturer(s) |
ich_3.2.s.2.1
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ICH | Active |
| ICH Context of Use | m3.2.s.2.2 description of manufacturing process and process controls |
ich_3.2.s.2.2
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ICH | Active |
| ICH Context of Use | m3.2.s.2.3 control of materials |
ich_3.2.s.2.3
|
ICH | Active |
| ICH Context of Use | m3.2.s.2.4 controls of critical steps and intermediates |
ich_3.2.s.2.4
|
ICH | Active |
| ICH Context of Use | m3.2.s.2.5 process validation and/or evaluation |
ich_3.2.s.2.5
|
ICH | Active |
| ICH Context of Use | m3.2.s.2.6 manufacturing process development |
ich_3.2.s.2.6
|
ICH | Active |
| ICH Context of Use | m3.2.s.3 characterisation |
ich_3.2.s.3
|
ICH | Active |
| ICH Context of Use | m3.2.s.3.1 elucidation of structure and other characteristics |
ich_3.2.s.3.1
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ICH | Active |
| ICH Context of Use | m3.2.s.3.2 impurities |
ich_3.2.s.3.2
|
ICH | Active |
| ICH Context of Use | m3.2.s.4 control of drug substance |
ich_3.2.s.4
|
ICH | Active |
| ICH Context of Use | m3.2.s.4.1 specification |
ich_3.2.s.4.1
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ICH | Active |
| ICH Context of Use | m3.2.s.4.2 analytical procedures |
ich_3.2.s.4.2
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ICH | Active |
| ICH Context of Use | m3.2.s.4.3 validation of analytical procedures |
ich_3.2.s.4.3
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ICH | Active |
| ICH Context of Use | m3.2.s.4.4 batch analyses |
ich_3.2.s.4.4
|
ICH | Active |
| ICH Context of Use | m3.2.s.4.5 justification of specification |
ich_3.2.s.4.5
|
ICH | Active |
| ICH Context of Use | m3.2.s.5 reference standards or materials |
ich_3.2.s.5
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ICH | Active |
| ICH Context of Use | m3.2.s.6 container closure system |
ich_3.2.s.6
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ICH | Active |
| ICH Context of Use | m3.2.s.7 stability |
ich_3.2.s.7
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ICH | Active |
| ICH Context of Use | m3.2.s.7.1 stability summary and conclusions |
ich_3.2.s.7.1
|
ICH | Active |
| ICH Context of Use | m3.2.s.7.2 post-approval stability protocol and stability commitment |
ich_3.2.s.7.2
|
ICH | Active |
| ICH Context of Use | m3.2.s.7.3 stability data |
ich_3.2.s.7.3
|
ICH | Active |
| ICH Context of Use | m3.3 literature references |
ich_3.3
|
ICH | Active |
| ICH Context of Use | m4.2.1.1 primary pharmacodynamics |
ich_4.2.1.1
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ICH | Active |
| ICH Context of Use | m4.2.1.2 secondary pharmacodynamics |
ich_4.2.1.2
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ICH | Active |
Showing 301–325 of 380 terms . Data sourced from public health authority publications and updated periodically.