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 | m1.9.4 proposed pediatric study request and amendments |
us_1.9.4
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FDA | — |
| US Context of Use | m1.9.3 request for pediatric exclusivity determination |
us_1.9.3
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FDA | — |
| US Context of Use | m1.9.2 request for deferral of pediatric studies |
us_1.9.2
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FDA | — |
| US Context of Use | m1.9.1 request for waiver of pediatric studies |
us_1.9.1
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FDA | — |
| EU Context of Use | M1.9 Information Relating to Clinical Trials |
100000164057
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EMA | Active |
| Context of Use | M1.9 Fast Track Status Decision |
110074
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SwissMedic | — |
| US Context of Use | m1.8.4 animal efficacy study for approval under the animal rule |
us_1.8.4
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FDA | — |
| US Context of Use | m1.8.3 stability study |
us_1.8.3
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FDA | — |
| Context of Use | M1.8.2 Risk-Management System |
110073
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SwissMedic | — |
| EU Context of Use | M1.8.2 Risk Management System |
100000164056
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EMA | Active |
| US Context of Use | m1.8.2 carcinogenicity study |
us_1.8.2
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FDA | — |
| EU Context of Use | M1.8.1 Pharmacovigilance System |
100000164055
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EMA | Active |
| Context of Use | M1.8.1 Pharmacovigilance System |
110072
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SwissMedic | — |
| US Context of Use | m1.8.1 clinical study |
us_1.8.1
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FDA | — |
| Context of Use | M1.8 Information Relating to Pharmacovigilance |
110071
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SwissMedic | — |
| Context of Use | M1.7.6 Article 13 TPA Additional Documentation |
110070
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SwissMedic | — |
| Context of Use | M1.7.5 Decisions of Other Foreign Authorities |
110069
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SwissMedic | — |
| Context of Use | M1.7.4 FDA Decision |
110068
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SwissMedic | — |
| US Context of Use | m1.7.4 correspondence regarding fast track rolling review |
us_1.7.4
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FDA | — |
| US Context of Use | m1.7.3 rolling review request |
us_1.7.3
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FDA | — |
| Context of Use | M1.7.3 EU Decision |
110067
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SwissMedic | — |
| EU Context of Use | M1.7.2 Market Exclusivity |
100000164053
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EMA | Active |
| US Context of Use | m1.7.2 fast track designation withdrawal request |
us_1.7.2
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FDA | — |
| Context of Use | M1.7.2 Assessment Report |
110066
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SwissMedic | — |
| EU Context of Use | M1.7.1 Similarity |
100000164052
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EMA | Active |
Showing 151–175 of 380 terms . Data sourced from public health authority publications and updated periodically.