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
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.