Difference between revisions of "Reviewable Unit (RPS)"

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==R1 Working Definition==
 
==R1 Working Definition==
Collection of one or more [[Submission Unit (RPS)|Submission Unit]]s that collectively become part of a [[Submission (RPS)|Submission]]. [not fully discussed]
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Collection of one or more [[Submission Unit (RPS)|Submission Unit]]s groupted together (usually by subject) that collectively become part of a [[Submission (RPS)|Submission]] for purpose of review. [not fully discussed]
  
 
==ICH Equivalent==
 
==ICH Equivalent==
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==Additional Regional Definitions and Synonyms==
 
==Additional Regional Definitions and Synonyms==
'''Definition in Japan (in the domain of human pharmaceuticals):'''
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===Human Pharmaceuticals===
 
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''No equivalent concepts have been found in any country''
No equivalent concept in Japan.
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===Devices===
 
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====United States===
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*Modules in a Modular PMA
 
[[Category:RPS Glossary]]
 
[[Category:RPS Glossary]]

Revision as of 16:02, 20 October 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 one or more Submission Units groupted together (usually by subject) that collectively become part of a Submission for purpose of review. [not fully discussed]

ICH Equivalent

none

BRIDG Term

Reviewable Unit (???)

A discrete portion of a submission which is used to receive agreement. Once agreement is reached on all units within the submission the submission can then be approved.

For example, in a Modular pre-marketing application (PMA) several modules will be sent to the Food & Drug Administration (FDA). Each module will be agreed upon independently of other modules. The FDA then approves the submission based on compilation of all of the modules. These modules are reviewable units.

For example, a veterinary medicine New Animal Drug Application (NADA) (marketing application) is constructed from the Investigational New Animal Drug Application (INADA). In the INADA process the sponsor creates reviewable units. These reviewable units are then compiled to be used as documentation for the marketing application.

Additional Regional Definitions and Synonyms

Human Pharmaceuticals

No equivalent concepts have been found in any country

Devices

=United States

  • Modules in a Modular PMA