Reviewable Unit (RPS)
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
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
- 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.
No equivalent concepts have been found in other countries and regions
- Modules in a Modular PMA
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