Difference between revisions of "Submission Unit (RPS)"
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==Additional Regional Definitions and Synonyms== | ==Additional Regional Definitions and Synonyms== | ||
| − | ===Human Pharmaceuticals | + | ===Human Pharmaceuticals=== |
| + | ====United States==== | ||
| + | The package of information set at any one point in time | ||
====Japan==== | ====Japan==== | ||
| − | + | ''no equivalent concept in Japan'' | |
| + | |||
===Devices=== | ===Devices=== | ||
====United States==== | ====United States==== | ||
| − | |||
| − | |||
*The package of information mailed at any one point in time | *The package of information mailed at any one point in time | ||
====Europe==== | ====Europe==== | ||
Latest revision as of 22:30, 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
The collection of Documents provided by the Sponsor to the Regulatory Authority at one time (although it can also be used for transfers of submission documents between two sponsors, between two authorities, or a contract organization and an sponsor). A Filing or Correspondence between parties. Submission Units are components of a Submission, and may be grouped into Reviewable Units.
ICH Equivalent
Sequence
BRIDG Term
Submission Unit
The collection of documents provided to the regulatory authority at one time.
NOTE: A submission unit is made up of one to many documents. Properly defined, the submission unit concept enables companies to create new submission units from any combination of new and previously submitted document.
NOTE: In the dynamic aspects of the model, a submission unit is one message that may have a collection of many documents. There are rules for how submission units are evaluated are described in a state diagram, and the receipt date of the submission unit "starts the clock" for the review of the contents of the submission unit.
Additional Regional Definitions and Synonyms
Human Pharmaceuticals
United States
The package of information set at any one point in time
Japan
no equivalent concept in Japan
Devices
United States
- The package of information mailed at any one point in time
Europe
- The package of information mailed at any one point in time
Canada
- The package of information mailed at any one point in time
Australia
- The package of information mailed at any one point in time
How does information entered into DEAL relate to the Submission Unit?
Singapore
- The package of documents uploaded onto the agency's website.
China
- The package of information mailed at any one point in time
