Difference between revisions of "Application (RPS)"
Joelfinkle (talk | contribs) |
Joelfinkle (talk | contribs) |
||
| Line 1: | Line 1: | ||
| − | |||
| − | |||
This is a Glossary page | This is a Glossary page | ||
| Line 10: | Line 8: | ||
==BRIDG Term== | ==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. | 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. | ||
Revision as of 16:32, 19 September 2008
This is a Glossary page
R1 Working Definition
Collection of related Regulatory Activities (RPS1 "Submissions").
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
