Difference between revisions of "Regulated Product Submission Release 2 (RPS R2) Business Scenario Development"
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+ | [[Category:RCRIM]] | ||
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+ | [[Regulated Product Submissions]] | [[RPS R2 Project]] | RPS R2 Business Scenarios | ||
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'''PARTICIPANT INSTRUCTIONS''' | '''PARTICIPANT INSTRUCTIONS''' | ||
− | Please use this page to develop content for the Regulated Product Submission business scenarios. To edit any individual scenario, click on the '''edit''' hyperlink for the section. If you wish to discuss any scenario, go to the '''discussion''' tab for this page click on the '''edit''' hyperlink for the | + | Please use this page to develop content for the Regulated Product Submission business scenarios. To edit any individual scenario, click on the '''edit''' hyperlink for the section. If you wish to discuss any scenario, go to the '''discussion''' tab for this page click on the '''edit''' hyperlink for the section corresponding to the scenario or general discussion topic. When you have finished your editing, click on the '''Save page''' button. |
=Introduction= | =Introduction= | ||
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|width="10%"|'''Actors''' | |width="10%"|'''Actors''' | ||
|width="90%"| | |width="90%"| | ||
− | * Regulated Industry (e.g., Sponsor, Applicant, “Submitting Entity”) | + | * Regulated Industry (e.g., [[Sponsor (RPS)|Sponsor]], Applicant, “Submitting Entity”) |
− | * Regulatory Authorities | + | * [[Regulatory Authority (RPS)|Regulatory Authorities]] |
|-valign="top" | |-valign="top" | ||
|'''Description''' | |'''Description''' | ||
− | |Request for Submission Number (with the idea that this may be done in an automated pre-submission manner). | + | |Request for [[Submission (RPS)|Submission] Number (with the idea that this may be done in an automated pre-submission manner). |
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|-valign="top" | |-valign="top" | ||
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* Should Post-market Commitment be included in Regulatory Actions? | * Should Post-market Commitment be included in Regulatory Actions? | ||
− | * What | + | * What are the definitions of [[Correspondence (RPS)|Correspondence]] and [[Message (RPS)|Message]]? |
− | * What differentiates a | + | * What differentiates a [[Submission Unit (RPS)|Submission Unit]] from correspondence? Will any correspondence get part of the application? It is usually considered part of the [[Application (RPS)|Application]] documentation. |
* Can this business scenario also capture the administrative activities (i.e., technical issues, validations, etc.)? | * Can this business scenario also capture the administrative activities (i.e., technical issues, validations, etc.)? | ||
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===Meeting Requests and Responses=== | ===Meeting Requests and Responses=== | ||
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|'''Additional Information''' | |'''Additional Information''' | ||
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| Are there any other examples? | | Are there any other examples? | ||
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==Referencing== | ==Referencing== | ||
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− | ===Referencing Information | + | ===Referencing Information Owned by an External Party=== |
{| border="1" cellpadding="5" cellspacing="0" | {| border="1" cellpadding="5" cellspacing="0" | ||
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Is the Right of Reference Request for this scenario required? What if a letter of authorization is withdrawn? | Is the Right of Reference Request for this scenario required? What if a letter of authorization is withdrawn? | ||
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===Updating Information that Links to Other Information=== | ===Updating Information that Links to Other Information=== |
Latest revision as of 14:53, 25 August 2010
Regulated Product Submissions | RPS R2 Project | RPS R2 Business Scenarios
PARTICIPANT INSTRUCTIONS
Please use this page to develop content for the Regulated Product Submission business scenarios. To edit any individual scenario, click on the edit hyperlink for the section. If you wish to discuss any scenario, go to the discussion tab for this page click on the edit hyperlink for the section corresponding to the scenario or general discussion topic. When you have finished your editing, click on the Save page button.
Contents
- 1 Introduction
- 2 Scenarios
- 2.1 Two-way Communication
- 2.1.1 Submission Activities
- 2.1.2 Meeting Requests and Responses
- 2.1.3 Follow-up/Post-market
- 2.1.4 Pre-submission Activities
- 2.1.5 Informal Interactions
- 2.1.6 Waiver Requests
- 2.1.7 Notification of Decision
- 2.1.8 Recalls
- 2.1.9 Withdraw from Market after Approval
- 2.1.10 Public Health Risk Notification
- 2.1.11 Labeling Negotiations: Request for Additional Information
- 2.1.12 Interagency Negotiations
- 2.1.13 Questions about where to find content (“I can’t find it”)
- 2.1.14 Questions from Sponsor to Agency and Resulting Response
- 2.1.15 Questions from Regulatory Authority and Sponsor Response
- 2.1.16 Identify Administrative Actions
- 2.2 Referencing
- 2.2.1 Reference Document within Submission Unit
- 2.2.2 Referencing Document between Submissions
- 2.2.3 Referencing outside Submission Unit, but within Application
- 2.2.4 Reference Information in Another Application
- 2.2.5 Referencing Information Owned by an External Party
- 2.2.6 Updating Information that Links to Other Information
- 2.2.7 Update a Referenced Document in a Previous Submission
- 2.2.8 Indirect Referencing
- 2.2.9 Reference Paper Information from Electronic Source
- 2.2.10 Reference External Electronic Source/Non-Retrievable
- 2.2.11 Reference Electronic Source/Retrievable
- 2.2.12 Referencing Approval Information
- 2.2.13 Provide Access/Permission to a Submission
- 2.2.14 Permit Use of Master File/Master Access
- 2.2.15 Comparison Information
- 2.3 Information about the Submission
- 2.1 Two-way Communication
Introduction
In its primary form, this page consolidates the information drafted and discussed during the business scenario development sessions at the July 24, 2008, Requirements Kick-off meeting in Silver Spring, Maryland. The business scenarios have three categories, corresponsing to the three scoping statements:
Scenarios
Two-way Communication
Submission Activities
Actors |
| |
Description | Request for [[Submission (RPS)|Submission] Number (with the idea that this may be done in an automated pre-submission manner). | |
Additional Information | Review Guidance Documents from each Authority (Note: May be difficult for EU) | |
Issues and Questions |
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Meeting Requests and Responses
Actors |
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Description |
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Additional Information | - | |
Issues and Questions |
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Follow-up/Post-market
Actors |
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Description |
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Additional Information | - | |
Issues and Questions |
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Pre-submission Activities
Actors |
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Description |
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Additional Information | - | |
Issues and Questions | The group indicated that "pre-submission" requires definition. |
Informal Interactions
Actors |
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Description |
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Additional Information | Refer to FDA/CDRH Guidance for Interactive Review | |
Issues and Questions |
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Waiver Requests
Actors |
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Description |
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Additional Information | - | |
Issues and Questions | This scenario needs examples of waivers |
Notification of Decision
Actors |
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Description |
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Additional Information | - | |
Issues and Questions | Are there any other status options? |
Recalls
Actors |
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Description | Health Authority contacts sponsor of required recall | |
Additional Information |
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Issues and Questions | - |
Withdraw from Market after Approval
Actors |
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Description |
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Additional Information |
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Issues and Questions | - |
Public Health Risk Notification
Actors |
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Description |
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Additional Information |
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Issues and Questions | DEFINE ACRONYM: Does BoH mean Board of Health? |
Labeling Negotiations: Request for Additional Information
Actors |
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Description |
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Additional Information | - | |
Issues and Questions |
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Interagency Negotiations
Actors |
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Description |
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Additional Information | - | |
Issues and Questions | Can the two agencies exchange questions once the negotiation is initiated? |
Questions about where to find content (“I can’t find it”)
Actors |
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Description |
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Additional Information | This communication is accepted by e-mail, phone, fax, or formal letter. | |
Issues and Questions | Is this an informal interaction? Once the information was not located within previously submitted documentation, is that when it becomes formal? |
Questions from Sponsor to Agency and Resulting Response
Actors |
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Description |
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Additional Information | This communication is accepted by e-mail, phone, or formal letter | |
Issues and Questions | - |
Questions from Regulatory Authority and Sponsor Response
Actors |
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Description |
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Additional Information | - | |
Issues and Questions | - |
Identify Administrative Actions
Actors |
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Description |
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Additional Information | - | |
Issues and Questions | Are there any other examples? |
Referencing
Reference Document within Submission Unit
Actors |
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Description |
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Additional Information |
“Reference” is one of the following:
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Issues and Questions | - |
Referencing Document between Submissions
Actors |
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Description |
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Additional Information | Link this to Request for Additional Information – Questions from Regulatory Authority and Response from Sponsor | |
Issues and Questions | - |
Referencing outside Submission Unit, but within Application
Actors |
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Description |
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Additional Information | - | |
Issues and Questions | How is this different than what is covered under RPS R1? |
Reference Information in Another Application
Actors |
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Description |
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Additional Information | The context which the documentation is being used in each application may need to be specified. The Sponsor may want to use the same content across applications, but in a different context in each. | |
Issues and Questions |
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Referencing Information Owned by an External Party
Actors |
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Description |
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Additional Information | - | |
Issues and Questions |
Is the Right of Reference Request for this scenario required? What if a letter of authorization is withdrawn? |
Updating Information that Links to Other Information
Actors |
| |
Description | Best Pharma has submitted an application with document that has reference to other documents within the application and to different application(s). This submission has been received by the Agency and they have validated the references. Subsequent to the original submission, Best Pharma has new CMC information that needs to be updated. A maintenance submission is submitted with an updated document, which has updated reference from what was submitted in the original submission. | |
Additional Information | - | |
Issues and Questions | - |
Update a Referenced Document in a Previous Submission
Actors |
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Description |
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Additional Information | - | |
Issues and Questions | - |
Indirect Referencing
Actors |
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Description | Reference information source that in turn references a secondary source.
Example, sNDA (new indication) references an original NDA, which in turn references an IND |
|
Additional Information | - | |
Issues and Questions | - |
Reference Paper Information from Electronic Source
Actors |
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Description | An electronic source submission references information that does not exist in any electronic reference“able” format. The referenced information only exists in paper.
Example: New indication sNDA reference older paper NDA for non-clinical safety information. |
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Additional Information | - | |
Issues and Questions |
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Reference External Electronic Source/Non-Retrievable
Actors |
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Description | This allows the sponsor to include a link outside or external to the application, but the information not displayed within the current review tool. This could require the requestor to access another system to review the data or content in relation to the external link. | |
Additional Information |
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Issues and Questions | This needs an example. What type of information are we referencing? Is it an external repository? Is this for the example of annotated ECG? |
Reference Electronic Source/Retrievable
Actors |
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Description | Generic Pharma submits and ANDA to a Regulatory Agency. As part of the submission, Generic Pharma needs to reference the original inventor labeling information posted on the Agency’s website. Generic Pharma references the original labeling information by establishing a retrievable link to the Agency’s website. | |
Additional Information | - | |
Issues and Questions | What if the website is updated after the submission and reference to the information? How do you handle references that have been changed after the submission reference? Nested references may lead to outdated or replaced information. |
Referencing Approval Information
Actors |
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Description | Information is submitted in a modular format and receives approvable status. Several modules and letters are exchanged. The final application would consist of links to the series of approvable letters. | |
Additional Information | - | |
Issues and Questions | Could this also include references to approvals external to the applicant to note previously approved products that are similar (i.e., substantially equivalent). |
Provide Access/Permission to a Submission
Actors |
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Description |
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Additional Information | Permission should include: Sponsor ID, investigator ID, access to what (and where is it, what agency, center), access level (granularity of reference or permission to what is in the file), date permission was given and/or withdrawn. | |
Issues and Questions | Does this apply outside the U.S.? |
Permit Use of Master File/Master Access
Actors |
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Description |
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Additional Information |
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Issues and Questions | For EU, how much referring do they do between EMEA and others...?
Also, for the EU, is it an open vs. closed DMF? This would affect access level. |
Comparison Information
Actors |
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Description |
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Additional Information |
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Issues and Questions | - |
Information about the Submission
Information about the Submission
Actors |
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Description |
This refers to providing basic administrative information about the message including, but not limited to:
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Additional Information |
Assess the common forms across the regulatory authorities. |
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Issues and Questions |
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