This wiki has undergone a migration to Confluence found Here

Difference between revisions of "Application (RPS)"

From HL7Wiki
Jump to navigation Jump to search
Line 28: Line 28:
No difference from "Submission".
No difference from "Submission" in Japan.
[[Category:RPS Glossary]]
[[Category:RPS Glossary]]

Revision as of 08:29, 30 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

Collection of related Regulatory Activities (RPS1 Submissions) for the regulated Products.

ICH Equivalent



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

Additional Regional Definitions and Synonyms

Definition in Japan (in the domain of human pharmaceuticals):

Similar to "hinmoku" in Japanese.

A collection of structured documents, which as a whole is identified by a submission number and to which as a whole a decision is made by Agency.

An application can have multiple submission units.

No difference from "Submission" in Japan.