Difference between revisions of "Application (RPS)"
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==R1 Working Definition== | ==R1 Working Definition== | ||
| − | Collection of related Regulatory Activities ([[RPS | + | Collection of related Regulatory Activities ([[Submission (RPS)|RPS1 "Submissions"]]). |
==ICH Equivalent== | ==ICH Equivalent== | ||
Revision as of 16:26, 19 September 2008
RPS Application
This is a Glossary page
R1 Working Definition
Collection of related Regulatory Activities (RPS1 "Submissions").
ICH Equivalent
None
BRIDG Term
Reglatory 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
