Statements (21)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
regulatory guideline
|
| gptkbp:appliesTo |
biotechnology industry
pharmaceutical industry |
| gptkbp:availableOn |
ema.europa.eu
|
| gptkbp:covers |
clinical trials
quality assurance biosimilars orphan drugs veterinary medicines advanced therapy medicinal products good manufacturing practice marketing authorization medicinal products pharmacovigilance |
| https://www.w3.org/2000/01/rdf-schema#label |
EMA guidelines
|
| gptkbp:issuedBy |
gptkb:European_Medicines_Agency
|
| gptkbp:language |
English
|
| gptkbp:region |
gptkb:European_Union
|
| gptkbp:updated |
gptkb:European_Medicines_Agency
|
| gptkbp:bfsParent |
gptkb:clinical_trial
|
| gptkbp:bfsLayer |
6
|