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.
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
A collection of documents compiled by a pharmaceutical company or its agent in compliance with European legislation and guidelines in order to seek a marketing authorisation or any amendments thereof.
- Similar to "shinsei".
A collection of shinki and/or ichihen , which as a whole being submitted to Agency at one time. A shinsei is identified by eCTD Receipt Number.
A shinsei can have multiple shinki and/or ichihen.
- An original PMA
- An original HDE
- An original IDE
- A Traditional 510(K)
- An 801(e) applicaiton
- An 802(g) application
Note: The BRIDG Definition is not true for devices. A single PMA may have many devices. Quite a few would have been approved by different submissions under the application
- Manufacturer's Evidence
- Full Conformity Assessment
- Device Application Class 1 - ClassIIB (Without L1 Audit)
- Device Application Class 1 - Class IIB (With L1 Audit)
- Device Application Class III - AIMD with L2 Audit
- A new submission leading to the issuing of a license number by the regulatory body
- A New Medical Device License Application
- In Investigational Testing Application
- Each certificate number issued by the notified body is a new application.
- Each technical file for self certification products is a new application.
One SFDA registration or renewal of one product should trigger an application