Difference between revisions of "Submission (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==
One Regulatory Activity, reviewed and potentially approved that may belong to many Dossiers ([[Application (RPS)|RPS1 "Applications"]]) and may potentially consist of many separate Packages ([[Submission Unit (RPS)|RPS1 "Submission Units"]]).
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One Regulatory Activity, reviewed and potentially approved that may belong to many Dossiers ([[Application (RPS)|RPS1 "Applications"]]) and may potentially consist of many separate Packages ([[Submission Unit (RPS)|RPS1 "Submission Units"]]), which may be grouped into [[Reviewable Unit (RPS)|Reviewable Units]].
  
 
==ICH Equivalent==
 
==ICH Equivalent==

Revision as of 16:45, 19 September 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

One Regulatory Activity, reviewed and potentially approved that may belong to many Dossiers (RPS1 "Applications") and may potentially consist of many separate Packages (RPS1 "Submission Units"), which may be grouped into Reviewable Units.

ICH Equivalent

This varies, including "Application", "Submission" and "Sequence".

BRIDG Term

Submission - A compilation of the contents of one or more submission units that supports a specific regulatory purpose or decision.

For example, a request for approval to either market a product or to allow the applicant to start testing of a proposed product.

NOTE: In most cases, the compilation of the submission units is used to assess a product's quality, safety and effectiveness.

NOTE: Submissions are always associated with some regulatory action (or inaction). Each submission contains their own regulatory action. Submissions (e.g., initial marketing application, supplemental marketing application) would generally be comprised of multiple submissions units.

NOTE: Most typically the submission will be used to organize information based on a review clock. Receipt date from the regulatory authority is important for a submission.

NOTE: Submissions can be the "complete" submission, or some portion of a "reviewable unit". In this setting the kind of regulatory decision is different.