Difference between revisions of "Application (RPS)"
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==R1 Working Definition== | ==R1 Working Definition== | ||
| − | Collection of related Regulatory Activities ([[Submission (RPS)|RPS1 "Submissions"]]) for | + | Collection of related Regulatory Activities ([[Submission (RPS)|RPS1 "Submissions"]]) for the regulated [[Product (RPS)|Products]]. |
==ICH Equivalent== | ==ICH Equivalent== | ||
Revision as of 18:35, 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
Contents
R1 Working Definition
Collection of related Regulatory Activities (RPS1 "Submissions") for the regulated Products.
ICH Equivalent
None
BRIDG Term
Regulatory Application
A collection of submissions that are grouped together for regulatory purposes, and are usually specific to a particular device, food or feed additive or biopharmaceutical substance.
For example, the marketing application for a drug product can generate multiple regulatory decisions. The first decision may support the initial marketing approval of the product for a specific indication. Subsequent regulatory decisions may approve or deny additional indications for the drug product. The application thus contains multiple submissions, each with their own regulatory action.
NOTE: Over time, an application will typically consist of multiple submissions and regulatory assessments
