Difference between revisions of "Application (RPS)"

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== RPS Application ==
 
 
 
This is a Glossary page
 
This is a Glossary page
  
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==BRIDG Term==
 
==BRIDG Term==
'''Reglatory 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.
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'''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.  

Revision as of 16:32, 19 September 2008

This is a Glossary page

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