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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| US Context of Use | m1.11.3 clinical information amendment |
us_1.11.3
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FDA | — |
| US Context of Use | m1.11.2 nonclinical information amendment |
us_1.11.2
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FDA | — |
| US Context of Use | m1.11.1 quality information amendment |
us_1.11.1
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FDA | — |
| Context of Use | M1.11 Orphan Drug Status Decision |
110076
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SwissMedic | — |
| US Context of Use | m1.10.2 correspondence related to dispute resolution |
us_1.10.2
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FDA | — |
| US Context of Use | m1.10.1 request for dispute resolution |
us_1.10.1
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FDA | — |
| EU Context of Use | M1.10 Information Relating to Paediatrics |
100000164058
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EMA | Active |
| Context of Use | M1.10 Information Relating to Paediatrics |
110075
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SwissMedic | — |
| US Context of Use | m1.1 forms |
us_1.1
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FDA | — |
| EU Context of Use | M1.0 Cover Letter and Tracking Table |
100000164029
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EMA | Active |
| Context of Use | M1.0 Cover Letter |
110002
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SwissMedic | — |
| Context of Use | M1 CH Regional Information |
110001
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SwissMedic | — |
| US CoU Keyword Definition Type | issue-date |
us_keyword_definition_type_2
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FDA | — |
| ICH Context of Use Status | current |
active
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ICH | Active |
| Context of Use | Additional Information |
110083
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SwissMedic | — |
| Context of Use | 1.5.3++ |
110059
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SwissMedic | — |
| Context of Use | 1.2.2.9++ |
110014
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SwissMedic | — |
| Context of Use | 1.2.2.7++ |
110012
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SwissMedic | — |
| Context of Use | 1.2.2.6++ |
110011
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SwissMedic | — |
| Context of Use | 1.2.2.5++ |
110010
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SwissMedic | — |
| Context of Use | 1.2.2.4++ |
110009
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SwissMedic | — |
| Context of Use | 1.2.2.24++ |
110029
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SwissMedic | — |
| Context of Use | 1.2.2.22++ |
110027
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SwissMedic | — |
| Context of Use | 1.2.2.21++ |
110026
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SwissMedic | — |
| Context of Use | 1.2.2.14++ |
110019
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SwissMedic | — |
Showing 351–375 of 380 terms . Data sourced from public health authority publications and updated periodically.