Application (RPS)

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. A more general term for this would be a Dossier, as some of the Regulatory Activities are not applications for an action, just a filing of information.

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

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.