: Public Class
Created: 2/13/2008 1:26:45 PM
Modified: 2/23/2012 4:18:56 PM
Project:
Advanced:
DEFINITION:<br /></p><p>Governmental bodies that have the power to pass and enforce laws.<br /></p><p><br /></p><p>EXAMPLE(S):<br /></p><p>Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK, Food and Drug Administration (FDA) in the USA<br /></p><p><br /></p><p>OTHER NAME(S):<br /></p><p><br /></p><p>NOTE(S):<br /></p>
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:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;A coded value specifying the type of governance over which an authority has to make laws and enforce them. #lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;EXAMPLE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;The Food and Drug Administration (FDA) exercises responsibility for pharmacovigilance (jurisdictionAuthorityCode) in the United States (Place.identifierCode).#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;OTHER NAME(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;NOTE(S):#lt;br /#gt;#lt;/p#gt;
Public IVL<TS.DATETIME>
  effectiveDateRange
Details:
Map:CTRPv1.0=RegulatoryAuthority.statusCode
Map:CTRPv1.0=RegulatoryAuthority.statusDateRange
Map:CTRv1.0=RegulatoryAuthority.effectiveDateRange
Notes: DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;The date and time span for when the regulatory authority is active.#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;EXAMPLE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;OTHER NAME(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;NOTE(S):#lt;br /#gt;#lt;/p#gt;
Element Source Role Target Role
RegulatoryAssessment
Class   		Name: performedRegulatoryAssessment
  		Name: performingRegulatoryAuthority
 
Details:
DESCRIPTION:<br /></p><p>Each RegulatoryAssessment always is performed by one RegulatoryAuthority.  Each RegulatoryAuthority might perform one or more RegulatoryAssessment.<br /></p><p><br /></p><p>DEFINITION:<br /></p><p><br /></p><p>EXAMPLE(S):<br /></p><p><br /></p><p>OTHER NAME(S):<br /></p><p><br /></p><p>NOTE(S):<br /></p>
Place
Class   		Name: locatingPlace
  		Name: locatedRegulatoryAuthority
 
Details:
DESCRIPTION:<br /></p><p>Each Place might be the location for one RegulatoryAuthority. Each RegulatoryAuthority might have jurisdiction over one or more Place.<br /></p><p><br /></p><p>DEFINITION:<br /></p><p><br /></p><p>EXAMPLE(S):<br /></p><p><br /></p><p>OTHER NAME(S):<br /></p><p><br /></p><p>NOTE(S):<br /></p>
MaterialName
Class   		Name: approvedMaterialName
  		Name: approvingRegulatoryAuthority
 
Details:
DESCRIPTION:<br /></p><p>Each MaterialName might be approved by one RegulatoryAuthority. Each RegulatoryAuthority might approve one or more MaterialName.<br /></p><p><br /></p><p>DEFINITION:<br /></p><p><br /></p><p>EXAMPLE(S):<br /></p><p><br /></p><p>OTHER NAME(S):<br /></p><p><br /></p><p>NOTE(S):<br /></p>
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):