Difference between revisions of "Submission Unit (RPS)"

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===Devices===
 
===Devices===
 
====United States====
 
====United States====
*The package of information mailed at any one point in time
 
====Japan====
 
 
*The package of information mailed at any one point in time
 
*The package of information mailed at any one point in time
 
====Europe====
 
====Europe====

Revision as of 14:21, 28 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

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

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.

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