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
|
Agency
Name of the issuing Health Authority (abbreviation) that maintains the term and code
|
Status
Current status of the Term usage as defined by the Health Authority (e.g., Current, Retired, Deprecated)
|
|---|---|---|---|---|
| US Application Type | Drug Master File (MF) |
us_application_type_5
|
FDA | — |
| Submission Type | Drug Master File |
100015
|
SwissMedic | — |
| US Submission Unit Type | Correspondence |
us_submission_unit_type_7
|
FDA | — |
| EU Application Submission Type | Corrective Action/Preventive Action related to a post-authorisation measure |
200000002300
|
EMA | Active |
| Submission Type | Co-Marketing Medicinal Product |
100003
|
SwissMedic | — |
| EU Application Submission Type | Clinical data for publication – Redacted Proposal |
200000002292
|
EMA | Active |
| EU Application Submission Type | Clinical data for publication – Final Version |
200000002291
|
EMA | Active |
| US Submission Type | Chemistry Manufacturing Controls Supplement |
us_submission_type_3
|
FDA | — |
| EU Application Submission Type | Certificate of suitability application to EDQM |
200000002290
|
EMA | Active |
| US Application Type | Biologic License Application (BLA) |
us_application_type_3
|
FDA | — |
| EU Application Submission Type | Article 18 |
220000000042
|
EMA | Active |
| Submission Type | Application for recognition of orphan drug status or fast track status |
100017
|
SwissMedic | — |
| US Submission Unit Type | Application |
us_submission_unit_type_3
|
FDA | — |
| US Submission Type | Annual Report |
us_submission_type_5
|
FDA | — |
| EU Application Submission Type | Annual Reassessment |
100000155703
|
EMA | Active |
| EU Application Submission Type | Annex II condition related to a post-authorisation measure |
200000002299
|
EMA | Active |
| US Submission Unit Type | Amendment |
us_submission_unit_type_4
|
FDA | — |
| Submission Type | Advice |
100018
|
SwissMedic | — |
| EU Application Submission Type | Additional pharmacovigilance activity in the risk-management plan |
200000002302
|
EMA | Active |
| US Submission Unit Status | ActStatusActive |
active
|
FDA | — |
| EU Application Submission Type | Active Substance Master File |
100000155700
|
EMA | Active |
| US Application Type | Abbreviated New Drug Application (ANDA) |
us_application_type_2
|
FDA | — |
Showing 76–97 of 97 terms . Data sourced from public health authority publications and updated periodically.