This wiki has undergone a migration to Confluence found Here

Difference between revisions of "Application (RPS)"

From HL7Wiki
Jump to navigation Jump to search
m
Line 1: Line 1:
 
This is a Glossary page
 
This is a Glossary page
 +
 
''This page is under discussion and definitions and aligmnent with the BRIDG model have not yet been finalized''
 
''This page is under discussion and definitions and aligmnent with the BRIDG model have not yet been finalized''
  
Line 9: Line 10:
  
 
==BRIDG Term==
 
==BRIDG Term==
'''Regulatory Application''' - A collection of submissions that are grouped together for regulatory purposes, and are usually specific to a particular device, food or feed additive or biopharmaceutical substance.
+
'''Regulatory Application'''  
 +
 
 +
A collection of submissions that are grouped together for regulatory purposes, and are usually specific to a particular device, food or feed additive or biopharmaceutical substance.
  
 
For example, the marketing application for a drug product can generate multiple regulatory decisions. The first decision may support the initial marketing approval of the product for a specific indication. Subsequent regulatory decisions may approve or deny additional indications for the drug product. The application thus contains multiple submissions, each with their own regulatory action.  
 
For example, the marketing application for a drug product can generate multiple regulatory decisions. The first decision may support the initial marketing approval of the product for a specific indication. Subsequent regulatory decisions may approve or deny additional indications for the drug product. The application thus contains multiple submissions, each with their own regulatory action.  
  
 
NOTE: Over time, an application will typically consist of multiple submissions and regulatory assessments
 
NOTE: Over time, an application will typically consist of multiple submissions and regulatory assessments
 +
 +
==Additional Regional Definitions and Synonyms==
 +
 
[[Category:RPS Glossary]]
 
[[Category:RPS Glossary]]

Revision as of 17:22, 19 September 2008

This is a Glossary page

This page is under discussion and definitions and aligmnent with the BRIDG model have not yet been finalized

R1 Working Definition

Collection of related Regulatory Activities (RPS1 "Submissions").

ICH Equivalent

None

BRIDG Term

Regulatory Application

A collection of submissions that are grouped together for regulatory purposes, and are usually specific to a particular device, food or feed additive or biopharmaceutical substance.

For example, the marketing application for a drug product can generate multiple regulatory decisions. The first decision may support the initial marketing approval of the product for a specific indication. Subsequent regulatory decisions may approve or deny additional indications for the drug product. The application thus contains multiple submissions, each with their own regulatory action.

NOTE: Over time, an application will typically consist of multiple submissions and regulatory assessments

Additional Regional Definitions and Synonyms