: Public <<DEPRECATED>> Class
Created: 2/13/2008 1:26:45 PM
Modified: 8/26/2017 2:46:29 AM
Project:
Advanced:
DEFINITION:<br/>Governmental bodies that have the power to pass and enforce laws.<br/><br/>EXAMPLE(S):<br/>Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK, Food and Drug Administration (FDA) in the USA<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
Attribute
Public CD
  jurisdictionAuthorityCode
Details:
Map:CTR&Rr2=SA from NCA
Map:CTR&Rr2=SA (Scientific Advice) from CHMP
Map:CTR&Rr2=SUSAR Reporting to NCAs
Map:CTR&Rr2=SUSAR Reporting to EVCTM
Map:CTRPv3.8=RegulatoryAuthority.jurisdictionCode
Map:CTRRr3=RegulatoryAuthority.jurisdictionCode
Map:CTRv1.0=RegulatoryAuthority.jurisdictionAuthorityCode
Notes: DEFINITION:<br/>A coded value specifying the type of governance over which an authority has to make laws and enforce them. <br/><br/>EXAMPLE(S):<br/>The Food and Drug Administration (FDA) exercises responsibility for pharmacovigilance (jurisdictionAuthorityCode) in the United States (Place.identifierCode).<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
Public IVL<TS.DATETIME>
  effectiveDateRange
Details:
Map:CTRPv1.0=RegulatoryAuthority.statusCode
Map:CTRPv1.0=RegulatoryAuthority.statusDateRange
Map:CTRv1.0=RegulatoryAuthority.effectiveDateRange
Notes: DEFINITION:<br/>The date and time span for when the regulatory authority is active.<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
Element Source Role Target Role
┬źDEPRECATED┬╗ RegulatoryAssessment
Class  
Name: performedRegulatoryAssessment
 
Name: performingRegulatoryAuthority
 
Details:
DESCRIPTION:<br/>Each RegulatoryAssessment always is performed by one RegulatoryAuthority.  Each RegulatoryAuthority might perform one or more RegulatoryAssessment.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>
MaterialName
Class  
Name: approvedMaterialName
 
Name: approvingRegulatoryAuthority
 
Details:
DESCRIPTION:<br/>Each MaterialName might be approved by one RegulatoryAuthority. Each RegulatoryAuthority might approve one or more MaterialName.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>
Place
Class  
Name: locatingPlace
 
Name: locatedRegulatoryAuthority
 
Details:
DESCRIPTION:<br/>Each Place might be the location for one RegulatoryAuthority. Each RegulatoryAuthority might have jurisdiction over one or more Place.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>
Tag Value
Map:AE RegulatoryAuthority
Details:
 
Map:CTRPv1.0 RegulatoryAuthority
Details:
 
Map:CTRPv3.8 RegulatoryAuthority
Details:
 
Map:CTRRr3 RegulatoryAuthority
Details:
 
Map:CTRv1.0 RegulatoryAuthority
Details:
 
Map:ICSRr2 territorialAuthority (in R_Product)
Details:
 
Map:ICSRr2 Author2 (in R_Product)
Details:
 
Object Type Connection Direction Notes
OversightAuthority Class Generalization To DESCRIPTION: Each RegulatoryAuthority always specializes one OversightAuthority. Each OversightAuthority might be specialized by one RegulatoryAuthority. DEFINITION: EXAMPLE(S): OTHER NAME(S): NOTE(S):