Difference between revisions of "Submission (RPS)"

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(New page: {{Category:RPS Glossary}} == RPS Submission== This is a Glossary page ==R1 Working Definition== One Regulatory Activity, reviewed and potentially approved that may belong to many Dossier...)
 
 
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{{Category:RPS Glossary}}
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This is a Glossary page
== RPS Submission==
 
  
This is a Glossary page
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''This page is under discussion and definitions and aligmnent with the BRIDG model have not yet been finalized''
  
 
==R1 Working Definition==
 
==R1 Working Definition==
One Regulatory Activity, reviewed and potentially approved that may belong to many Dossiers ([[RPS Application|RPS1 "Applications"]]) and may potentially consist of many separate Packages ([[RPS Submission Unit|RPS1 "Submission Units"]]).
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One [[Regulatory Activity]], consisting of a collection of  Packages ([[Submission Unit (RPS)|RPS1 Submission Unit]]s) (which may be grouped into [[Reviewable Unit (RPS)|Reviewable Unit]]s), to support one regulatory purpose. The purpose could be a notification of a change, or a request to approve a new product or change.
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A '''Submission''' is may or may not be reviewed or approved
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A '''Submission''' may belong to many [[Dossier]]s ([[Application (RPS)|RPS1 Application]]s).
  
 
==ICH Equivalent==
 
==ICH Equivalent==
This varies, including "Application", "Submission" and "Sequence".
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This varies, including '''Application''', '''Submission''' and '''Sequence'''.
  
 
==BRIDG Term==
 
==BRIDG Term==
'''Submission''' - A compilation of the contents of one or more submission units that supports a specific regulatory purpose or decision.  
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'''Submission'''
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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.
 
For example, a request for approval to either market a product or to allow the applicant to start testing of a proposed product.
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NOTE: Submissions can be the "complete" submission, or some portion of a "[[RPS Reviewable Unit|reviewable unit]]". In this setting the kind of regulatory decision is different.
 
NOTE: Submissions can be the "complete" submission, or some portion of a "[[RPS Reviewable Unit|reviewable unit]]". In this setting the kind of regulatory decision is different.
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==Additional Regional Definitions and Synonyms==
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''Note: Most of these definitions are for a subsequent submission.  For definitions and terms for initial submissions, see [[Application (RPS)|Application]].''
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===Human Pharmaceuticals===
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====United States====
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*[[New Drug Application]] Supplement
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*[[Investigational New Drug]] Supplement
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*[[Annual Report]]
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====Japan====
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*Covers "''shinki''" and "''ichihen''" in Japanese, but there is no equivalent Japanese term for submission.
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A collection of sequences, which as a whole is identified by System Receipt Number.
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An application can have multiple submission units.
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====Europe====
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A single set of information and/or documents supplied at one particular time by the applicat as a part of, or the complete, '''eCTD Application'''.  In the context of an eCTD, this is equivalent to a '''sequence'''.
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===Devices===
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====United States====
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*PMA Supplement
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*IDE Supplement
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*Special 510(k)
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*HDE Supplement
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*[[Annual Report]]
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====Europe====
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*A submission for a change to products already approved on an existing certificate
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*A submission to add a new product to an existing certificate
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*A renewal under the application for the certificate that is expiring
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====Canada====
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*Medical Device License Amendment
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*Faxbacks
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====China====
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*Any change request to a registration or renewal approval, including changing the manufacturer name, address, model name, legal contact and service contact in china.
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*Manual update notification
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====Singapore====
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*A supplementary submission for a change to an approved license
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*A supplementary submission to add new product(s) to an approved license
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====Australia====
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*Manufacturers Evidence Renewal
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*Addition of GMDN code to Manufacturers Evidence
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*Addition of DE/TE Certificate to Manufacturers Evidence
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*Variation to Full Conformity Assessment (i.e. changes in suppliers or sterilisation protocols or manufacturing site, etc.)
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*Variation to Class III or AIMD
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[[Category:RPS Glossary]]

Latest revision as of 06:44, 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

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

A Submission may belong to many Dossiers (RPS1 Applications).

ICH Equivalent

This varies, including Application, Submission and Sequence.

BRIDG Term

Submission

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

Note: Most of these definitions are for a subsequent submission. For definitions and terms for initial submissions, see Application.

Human Pharmaceuticals

United States

Japan

  • Covers "shinki" and "ichihen" in Japanese, but there is no equivalent Japanese term for submission.

A collection of sequences, which as a whole is identified by System Receipt Number.

An application can have multiple submission units.

Europe

A single set of information and/or documents supplied at one particular time by the applicat as a part of, or the complete, eCTD Application. In the context of an eCTD, this is equivalent to a sequence.

Devices

United States

  • PMA Supplement
  • IDE Supplement
  • Special 510(k)
  • HDE Supplement
  • Annual Report

Europe

  • A submission for a change to products already approved on an existing certificate
  • A submission to add a new product to an existing certificate
  • A renewal under the application for the certificate that is expiring

Canada

  • Medical Device License Amendment
  • Faxbacks

China

  • Any change request to a registration or renewal approval, including changing the manufacturer name, address, model name, legal contact and service contact in china.
  • Manual update notification

Singapore

  • A supplementary submission for a change to an approved license
  • A supplementary submission to add new product(s) to an approved license

Australia

  • Manufacturers Evidence Renewal
  • Addition of GMDN code to Manufacturers Evidence
  • Addition of DE/TE Certificate to Manufacturers Evidence
  • Variation to Full Conformity Assessment (i.e. changes in suppliers or sterilisation protocols or manufacturing site, etc.)
  • Variation to Class III or AIMD