Difference between revisions of "Application (RPS)"

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*Similar to "''shinsei''".
 
*Similar to "''shinsei''".
  
A collection of ''shinki'' or ''ichihen'' , which as a whole being submitted to Agency at one time.  A ''shinsei'' is identified by eCTD Receipt Number.
+
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''.
 
A shinsei can have multiple ''shinki'' and/or ''ichihen''.

Latest revision as of 06:41, 11 March 2009

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

Human Pharmaceuticals

United States

Europe

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.

Japan

  • 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.

Devices

United States

  • 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

Australia

  • 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

Singapore

  • A new submission leading to the issuing of a license number by the regulatory body

Canada

  • A New Medical Device License Application
  • In Investigational Testing Application

Europe

  • Each certificate number issued by the notified body is a new application.
  • Each technical file for self certification products is a new application.

China

One SFDA registration or renewal of one product should trigger an application