Difference between revisions of "Submission (RPS)"

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m (RPS Submission moved to Submission (RPS): Alphabeticization is kind of useless if everything starts with RPS)
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==R1 Working Definition==
 
==R1 Working Definition==
One Regulatory Activity, reviewed and potentially approved that may belong to many Dossiers ([[RPS Application|RPS1 "Applications"]]) and may potentially consist of many separate Packages ([[RPS Submission Unit|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"]]).
  
 
==ICH Equivalent==
 
==ICH Equivalent==

Revision as of 16:30, 19 September 2008

RPS Submission

This is a Glossary page

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").

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.