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 | m1.13.10 foreign marketing |
us_1.13.10
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FDA | — |
| US Context of Use | m1.13.1 summary for nonclinical studies |
us_1.13.1
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FDA | — |
| US Context of Use | m1.12.9 notification of discontinuation of clinical trial |
us_1.12.9
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FDA | — |
| US Context of Use | m1.12.8 correspondence regarding exception from informed consent for emergency research |
us_1.12.8
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FDA | — |
| US Context of Use | m1.12.7 public disclosure statement for exception from informed consent for emergency research |
us_1.12.7
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FDA | — |
| US Context of Use | m1.12.6 exception from informed consent for emergency research |
us_1.12.6
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FDA | — |
| US Context of Use | m1.12.5 request for a waiver |
us_1.12.5
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FDA | — |
| US Context of Use | m1.12.4 request for comments and advice |
us_1.12.4
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FDA | — |
| Context of Use | M1.12.4 Proof of 15 Years Cantonal Authorisation |
110081
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SwissMedic | — |
| US Context of Use | m1.12.3 request to charge for expanded access |
us_1.12.3
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FDA | — |
| Context of Use | M1.12.3 Proof of 30 Years Overall Medical Use - 15 Years Medical Use EU/EFTA |
110080
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SwissMedic | — |
| US Context of Use | m1.12.2 request to charge for clinical trial |
us_1.12.2
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FDA | — |
| US Context of Use | m1.12.18 regenerative medicine advanced therapy (rmat) designation |
us_1.12.18
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FDA | — |
| US Context of Use | m1.12.17 orphan drug designation |
us_1.12.17
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FDA | — |
| US Context of Use | m1.12.16 field alert reports |
us_1.12.16
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FDA | — |
| US Context of Use | m1.12.15 request for waiver of in vivo bioavailability studies |
us_1.12.15
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FDA | — |
| US Context of Use | m1.12.14 environmental analysis |
us_1.12.14
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FDA | — |
| US Context of Use | m1.12.13 request for waiver for in vivo studies |
us_1.12.13
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FDA | — |
| US Context of Use | m1.12.12 comparison of generic drug and reference listed drug |
us_1.12.12
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FDA | — |
| US Context of Use | m1.12.11 anda basis for submission statement |
us_1.12.11
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FDA | — |
| US Context of Use | m1.12.10 generic drug enforcement act statement |
us_1.12.10
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FDA | — |
| Context of Use | M1.12.1 Proof of 10 Years EU/EFTA Authorisation |
110078
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SwissMedic | — |
| US Context of Use | m1.12.1 pre ind correspondence |
us_1.12.1
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FDA | — |
| Context of Use | M1.12 Art 14 Sec 1 let abis-quater TPA Documents |
110077
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SwissMedic | — |
| US Context of Use | m1.11.4 multiple module information amendment |
us_1.11.4
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FDA | — |
Showing 326–350 of 380 terms . Data sourced from public health authority publications and updated periodically.