Difference between revisions of "Reviewable Unit (RPS)"
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This is a Glossary page | This is a Glossary page | ||
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| + | ''This page is under discussion and definitions and aligmnent with the BRIDG model have not yet been finalized'' | ||
==R1 Working Definition== | ==R1 Working Definition== | ||
| − | Collection of one or more [[Submission Unit (RPS)|Submission | + | 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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==BRIDG Term== | ==BRIDG Term== | ||
'''Reviewable Unit''' (???) | '''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. | 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. | ||
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==Additional Regional Definitions and Synonyms== | ==Additional Regional Definitions and Synonyms== | ||
| + | ===Human Pharmaceuticals=== | ||
| + | ====Japan==== | ||
| + | *Similar to "''teishutsu''": A collection of structured documents provided to the regulatory authority at one time. Each submission unit has a sequence number unique in that Submission/Application. | ||
| + | ====Elsewhere==== | ||
| + | ''No equivalent concepts have been found in other countries and regions'' | ||
| + | ===Devices=== | ||
| + | ===United States=== | ||
| + | *Modules in a Modular PMA | ||
[[Category:RPS Glossary]] | [[Category:RPS Glossary]] | ||
Latest revision as of 22:31, 10 November 2008
This is a Glossary page
This page is under discussion and definitions and aligmnent with the BRIDG model have not yet been finalized
Contents
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
Japan
- Similar to "teishutsu": A collection of structured documents provided to the regulatory authority at one time. Each submission unit has a sequence number unique in that Submission/Application.
Elsewhere
No equivalent concepts have been found in other countries and regions
Devices
United States
- Modules in a Modular PMA
