Difference between revisions of "Submission (RPS)"
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| − | + | This is a Glossary page | |
| − | This is | + | ''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, | + | 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. |
| + | |||
| + | A '''Submission''' is may or may not be reviewed or approved | ||
| + | |||
| + | A '''Submission''' may belong to many [[Dossier]]s ([[Application (RPS)|RPS1 Application]]s). | ||
==ICH Equivalent== | ==ICH Equivalent== | ||
| − | This varies, including | + | This varies, including '''Application''', '''Submission''' and '''Sequence'''. |
==BRIDG Term== | ==BRIDG Term== | ||
| − | '''Submission''' | + | '''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. | For example, a request for approval to either market a product or to allow the applicant to start testing of a proposed product. | ||
| Line 21: | Line 27: | ||
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. | ||
| + | |||
| + | ==Additional Regional Definitions and Synonyms== | ||
| + | ''Note: Most of these definitions are for a subsequent submission. For definitions and terms for initial submissions, see [[Application (RPS)|Application]].'' | ||
| + | ===Human Pharmaceuticals=== | ||
| + | ====United States==== | ||
| + | *[[New Drug Application]] Supplement | ||
| + | *[[Investigational New Drug]] Supplement | ||
| + | *[[Annual Report]] | ||
| + | ====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 | ||
| + | |||
[[Category:RPS Glossary]] | [[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
Contents
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
- New Drug Application Supplement
- Investigational New Drug Supplement
- Annual Report
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
