Statements (51)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
regulatory guideline
|
| gptkbp:appliesTo |
clinical trials
pharmaceutical industry medicinal products |
| gptkbp:availableOn |
ema.europa.eu
|
| gptkbp:compatibleWith |
clinical trial approval
manufacturing authorization marketing authorization pharmacovigilance activities product labelling product quality assurance |
| gptkbp:covers |
biosimilars
risk management data integrity veterinary medicines generics advanced therapy medicinal products biological medicines clinical data requirements electronic submissions environmental risk assessment good clinical practice good manufacturing practice good pharmacovigilance practice labelling and packaging medical devices (in some contexts) non-clinical studies orphan medicines paediatric medicines post-marketing surveillance preclinical data requirements quality documentation |
| gptkbp:enforcedBy |
gptkb:European_Union
gptkb:European_Economic_Area |
| gptkbp:firstIssueDate |
1995
|
| https://www.w3.org/2000/01/rdf-schema#label |
EMA Guidelines
|
| gptkbp:issuedBy |
gptkb:European_Medicines_Agency
|
| gptkbp:language |
English
|
| gptkbp:purpose |
ensure safety, efficacy, and quality of medicines
|
| gptkbp:relatedTo |
gptkb:ICH_Guidelines
gptkb:WHO_Guidelines gptkb:FDA_Guidelines |
| gptkbp:reviewedBy |
periodically
|
| gptkbp:updated |
gptkb:European_Medicines_Agency
|
| gptkbp:usedBy |
gptkb:contract_research_organizations
healthcare professionals pharmaceutical companies regulatory authorities marketing authorization applicants |
| gptkbp:bfsParent |
gptkb:Sequential_Medical_Trials
|
| gptkbp:bfsLayer |
5
|