Sponsor (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

An organization that assumes responsibility for producing and submitting documentation to a Regulatory Authority to seek approval for testing, marketing and the continuation of marketing of new regulated products.

For example, a pharmaceutical company.

ICH Equivalent

None

BRIDG Term

RegulatoryApplicationSponsor

An organization that assumes responsibility for producing and submitting documentation to a regulatory authority to seek approval for testing, marketing and the (continuation of marketing) of new drugs or devices.

For example, a pharmaceutical company.

Additional Regional Definitions and Synonyms

None

RPS Modeling Discussion

The Sponsor is one of two defined Actors in an RPS message, the other being the Regulatory Authority.

The Sponsor should be identified by a Unique Identifier, either an OID or a UUID. If an OID is used, it may be the root OID for all submissions and data in the RPS messages sent by that sponsor.