Type of regulatory submission / activity (e.g. initial, variation, renewal). Regionally defined.
|
HA Controlled Vocabulary
Controlled Vocabulary / Code System Name as defoined by the Health Authority
|
Term
Term Description as defined by the Health Authority
|
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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|---|---|---|---|---|
| Submission Type | Follow-up Measure |
100011
|
SwissMedic | — |
| US Submission Type | IND Safety Reports |
us_submission_type_9
|
FDA | — |
| EU Application Submission Type | Initial Marketing Authorisation Application |
100000155689
|
EMA | Active |
| US Application Type | Investigational Device Exemption (IDE) |
us_application_type_7
|
FDA | — |
| US Application Type | Investigational New Drug (IND) |
us_application_type_4
|
FDA | — |
| Submission Type | Known Active Substance |
100002
|
SwissMedic | — |
| US Submission Type | Labeling Supplement |
us_submission_type_4
|
FDA | — |
| EU Application Submission Type | Legally binding measure related to a post-authorisation measure |
200000002301
|
EMA | Active |
| EU Application Submission Type | Lifting of a Suspension |
100000155710
|
EMA | Active |
| EU Application Submission Type | Line Extension |
100000155695
|
EMA | Active |
| EU Application Submission Type | National Variation |
100000155694
|
EMA | Active |
| Submission Type | New Active Substance |
100001
|
SwissMedic | — |
| US Application Type | New Drug Application (NDA) |
us_application_type_1
|
FDA | — |
| Submission Type | No regulatory activity |
100019
|
SwissMedic | — |
| EU Application Submission Type | no regulatory activity |
200000002325
|
EMA | Active |
| EU Application Submission Type | Notification acc. Article 61(3) |
100000155708
|
EMA | Active |
| US Submission Unit Type | Original |
us_submission_unit_type_1
|
FDA | — |
| US Submission Type | Original Application |
us_submission_type_1
|
FDA | — |
| EU Application Submission Type | Paediatric investigational plan according to article 7, 8 or 30 of the Reg (EC) 1901/2006 |
200000002293
|
EMA | Active |
| EU Application Submission Type | Paediatric Submission acc. Article 29 |
100000155705
|
EMA | Active |
| EU Application Submission Type | Paediatric Submission acc. Article 46 |
100000155706
|
EMA | Active |
| EU Application Submission Type | Paediatric Submission acc. Article 46 |
200000043524
|
EMA | Active |
| Submission Type | Parallel Import |
100004
|
SwissMedic | — |
| US Submission Type | Periodic Safety Reports |
us_submission_type_10
|
FDA | — |
| EU Application Submission Type | Periodic Safety Update Report |
100000155696
|
EMA | Active |
Showing 26–50 of 97 terms . Data sourced from public health authority publications and updated periodically.