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
One Regulatory Activity, consisting of a collection of Packages (RPS1 Submission Units) (which may be grouped into Reviewable Units), to support one regulatory purpose. The purpose could be a notification of a change, or a request to approve a new product or change.
A Submission is may or may not be reviewed or approved
This varies, including Application, Submission and Sequence.
A compilation of the contents of one or more submission units that supports a specific regulatory purpose or decision.
For example, a request for approval to either market a product or to allow the applicant to start testing of a proposed product.
NOTE: In most cases, the compilation of the submission units is used to assess a product's quality, safety and effectiveness.
NOTE: Submissions are always associated with some regulatory action (or inaction). Each submission contains their own regulatory action. Submissions (e.g., initial marketing application, supplemental marketing application) would generally be comprised of multiple submissions units.
NOTE: Most typically the submission will be used to organize information based on a review clock. Receipt date from the regulatory authority is important for a submission.
NOTE: Submissions can be the "complete" submission, or some portion of a "reviewable unit". In this setting the kind of regulatory decision is different.
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 "Application" in Japan.