# Standard Agency ICSR Submissions

Vault supports ICSR submissions to standard agencies. This includes:

* Providing <a href="/en/gr/01252/">reporting rules</a> to evaluate _Submissions_
  * _Studies_ and _Case Products_ with an <a href="/en/gr/01250/#suspect-parameter">eligible _Drug Role_</a> that have registrations in a country within an agency's jurisdiction trigger reporting rules to evaluate submissions to that agency.
* Assigning jurisdictions, though you can <a href="/en/gr/01213/#update-agency-country-jurisdiction">update assigned country jurisdictions</a> to any agency based on your business process.
* Providing compliant report formats
* Supporting electronic communication
* Configurable <a href="/en/gr/01202/">_Transmission Profiles_</a>
* Gateway response mapping
* Limiting dual-language entry according to [_Localization Scope_][1]

## EMA

Set up ICSR submissions to the EMA using the following information:

* **Reporting rules**: The <a href="/en/gr/01252/#ema">EMA ICSR Reporting Rule Set</a>
* **Jurisdictions**:
  * Albania
  * Andorra
  * Austria
  * Belgium
  * Bosnia and Herzegovina
  * Bulgaria
  * Croatia
  * Cyprus
  * Czechia
  * Denmark
  * Estonia
  * Europe
  * Finland
  * France
  * Germany
  * Greece
  * Hungary
  * Iceland
  * Ireland
  * Italy
  * Latvia
  * Liechtenstein
  * Lithuania
  * Luxembourg
  * Malta
  * Moldova
  * Monaco
  * Montenegro
  * Netherlands (the)
  * North Macedonia
  * Norway
  * Poland
  * Portugal
  * Romania
  * San Marino
  * Serbia
  * Slovakia
  * Slovenia
  * Spain
  * Sweden
  * Ukraine
  * United Kingdom (Northern Ireland)
* **Report format**: <a href="/en/gr/700007/">EMA E2B(R3)</a>
* **AS2 Connection**: Configure the <a href="/en/gr/01452/">EMA AS2 Connection</a> to communicate electronically with the EMA through EudraVigilance.
* **Transmission Profiles**:
  * **EVCTMPROD**: For _Submissions_ to the EudraVigilance Clinical Trial Module (EVCTM)
  * **EVHUMAN**: For _Submissions_ to the EudraVigilance Post-Authorisation Module (EVPM)

### EMA MDN and ACKs

Vault maps EMA gateway responses to Vault response labels (ACK 1–4) and <a href="/en/gr/01266/#transmission-lc-states">Transmission lifecycle states</a>:

<table>
    <thead>
        <tr>
            <th>Vault Response Label</th>
            <th>Agency Response Type</th>
            <th>Vault Lifecycle States</th>
        </tr>
    </thead>
    <tbody>
        <tr>
            <td>ACK 1</td>
            <td>Handshake</td>
            <td>No state change</td>
        </tr>
        <tr>
            <td>ACK 2</td>
            <td>MDN (Async MDN)</td>
            <td>MDN Received</td>
        </tr>
        <tr>
            <td>ACK 3</td>
            <td>Final ACK</td>
            <td>
                <ul>
                    <li>ACK Accepted</li>
                    <li>ACK Rejected</li>
                    <li>ACK Warning</li>
                </ul>
            </td>
        </tr>
        <tr>
            <td>ACK 4</td>
            <td><em>n/a</em></td>
            <td><em>n/a</em></td>
        </tr>
    </tbody>
</table>

For help resolving EMA E2B(R3) issues, see <a href="/en/gr/01269/">Troubleshoot EMA Gateway Submissions</a>.

## FDA

Set up ICSR submissions to the FDA using the following information and links:

* **Reporting rules**: The <a href="/en/gr/01252/#psmr">FDA ICSR Reporting Rule Set</a>
* **Jurisdictions**:
  * American Samoa
  * Micronesia (Federated States of)
  * Guam
  * Marshall Islands (the)
  * Northern Mariana Islands (the)
  * Puerto Rico
  * Palau
  * United States Minor Outlying Islands (the)
  * United States of America
  * Virgin Islands (U.S.)
* **Report formats**:
  * <a href="/en/gr/802644/">FDA MedWatch 3500A</a>
  * <a href="/en/gr/936141/">FDA eMDR</a>
  * <a href="/en/gr/700010/">FDA E2B(R2)</a>
  * <a href="/en/gr/725757/">FDA E2B(R3)</a>
  * <a href="/en/gr/700006/">FDA VAERS E2B(R3)</a>
* **AS2 Connection**: Configure the <a href="/en/gr/01451/">FDA AS2 Connection</a> to communicate FDA ESG endpoints for electronic communications with the FDA.
* **Transmission Profiles**:
  * **CBER**: For ICSR _Transmissions_ to the Center for Biologics Evaluation and Research (CBER) with the FDA AS2 Connection
  * **CBER Study**: For study data _Transmissions_ to the Center for Biologics Evaluation and Research (CBER) with the FDA AS2 Connection. Requires <a href="/en/gr/678031/#activate-the-transmission-profiles">activation</a>.
  * **CBER VAERS**: For VAERS ICSR _Transmissions_ to the Center for Biologics Evaluation and Research (CBER) with the FDA AS2 Connection
  * **CDER**: For ICSR _Transmissions_ to the Center for Drug Evaluation and Research (CDER) with the FDA AS2 Connection
  * **CDER IND Exempt**: For study data _Transmissions_ for marketed products that are exempt from Investigational New Drugs (IND) requirements. Requires <a href="/en/gr/678031/#activate-the-transmission-profiles">activation</a>.
  * **CDER Study**: For study data _Transmissions_ to the Center for Drug Evaluation and Research (CDER) with the FDA AS2 Connection. Requires <a href="/en/gr/678031/#activate-the-transmission-profiles">activation</a>.
  * **FDA Study**: The FDA is entering a transition period and will be accepting both FDA MedWatch and FDA E2B(R3) formats. Follow your organization's procedures for determining how to submit premarket cases to the FDA. Previously, this _Transmission Profile_ was available to generate and manage manual Submissions for ICSRs in a clinical study using the FDA MedWatch 3500A form.
  * **GWTEST**: For test _Transmissions_ with the FDA AS2 Connection
  * **FDA eMDR**: For ICSR _Transmissions_ for the purposes of Electronic Medical Device Reporting with the FDA AS2 Connection.

### FDA MDN and ACKs

Vault maps FDA gateway responses to Vault response labels (ACK 1–4) and <a href="/en/gr/01266/#transmission-lc-states">Transmission lifecycle states</a>.

#### FDA FAERS

<table class="uk-table uk-table-hover uk-table-striped">
    <thead>
        <tr>
            <th>Vault Response Label</th>
            <th>Agency Response Type</th>
            <th>Vault Lifecycle States</th>
        </tr>
    </thead>
    <tbody>
        <tr>
            <td>ACK 1</td>
            <td>MDN (Sync MDN)</td>
            <td>MDN Received</td>
        </tr>
        <tr>
            <td>ACK 2</td>
            <td>Final ACK</td>
            <td>
                <ul>
                    <li>ACK Accepted</li>
                    <li>ACK Rejected</li>
                    <li>ACK Warning</li>
                </ul>
            </td>
        </tr>
        <tr>
            <td>ACK 3</td>
            <td><em>n/a</em></td>
            <td><em>n/a</em></td>
        </tr>
        <tr>
            <td>ACK 4</td>
            <td><em>n/a</em></td>
            <td><em>n/a</em></td>
        </tr>
    </tbody>
</table>

For help resolving FDA E2B(R2) issues, see <a href="/en/gr/01270/">Troubleshoot FDA Gateway Submissions</a>.

#### FDA VAERS

<table class="uk-table uk-table-hover uk-table-striped">
    <thead>
        <tr>
            <th>Vault Response Label</th>
            <th>Agency Response Type</th>
            <th>Vault Lifecycle States</th>
        </tr>
    </thead>
    <tbody>
        <tr>
            <td>ACK 1</td>
            <td>Handshake</td>
            <td>No state change</td>
        </tr>
        <tr>
            <td>ACK 2</td>
            <td>MDN (Async MDN)</td>
            <td>MDN Received</td>
        </tr>
        <tr>
            <td>ACK 3</td>
            <td>ACK 2</td>
            <td>No state change</td>
        </tr>
        <tr>
            <td>ACK 4</td>
            <td>Final ACK</td>
            <td>
                <ul>
                    <li>ACK Accepted</li>
                    <li>ACK Rejected</li>
                    <li>ACK Warning</li>
                </ul>
            </td>
        </tr>
    </tbody>
</table>

## Health Canada

Set up ICSR submissions to Health Canada using the following information and links:

* **Reporting rules**:
  * Vault does not currently have a designated rule set for Health Canada. However, you can use the <a href="/en/gr/01252/#psmr">FDA ICSR Reporting Rule Set</a> as a starting point to <a href="/en/gr/873466/">create a custom rule set</a> according to your business needs. Health Canada may be assigned this rule set already in certain Vaults.
  * By default, <a href="/en/gr/01246/">back reporting</a> is turned on for reports received from Health Canada.
* **Jurisdiction**: Canada
* **Report format**: <a href="/en/gr/700011/">Health Canada E2B(R2)</a>
* **AS2 Connection**:
  * Configure the <a href="/en/gr/01453/">Health Canada AS2 Connection</a> to communicate electronically with the Canada Vigilance Program (CVP).
  * Because Health Canada does not allow testing with third-party vendors, their gateway has not been vendor-tested with Veeva Safety. You must perform additional testing when setting up Health Canada electronic submissions.
* **Transmission Profiles**:
  * **HC MHPD**: For submitting postmarket reports to Health Canada's Marketed Health Products Directorate (MHPD)
  * **HC TPD**: For submitting clinical trial reports to the Health Canada's Therapeutic Products Directorate (TPD)

## MFDS

Set up ICSR submissions to the Republic of Korea's Ministry of Food and Drug Safety (MFDS) using the following information and links:

* **Jurisdiction**: The Republic of Korea
* **Report format**: <a href="/en/gr/782789/">MFDS E2B(R3)</a>
* **AS2 Connection**: Configure the <a href="/en/gr/728083/">MFDS AS2 Connection</a> to communicate electronically with the MFDS.
* **Transmission Profile**: Set up the MFDS <a href="/en/gr/01202/">_Transmission Profile_</a>.

### MFDS MDN and ACKs

Vault maps MFDS gateway responses to Vault response labels (ACK 1–4) and _Transmission_ lifecycle states:

<table>
    <thead>
        <tr>
            <th>Vault Response Label</th>
            <th>Agency Response Type</th>
            <th>Vault Lifecycle States</th>
        </tr>
    </thead>
    <tbody>
        <tr>
            <td>ACK 1</td>
            <td>MDN (Async MDN)</td>
            <td>MDN Received</td>
        </tr>
        <tr>
            <td>ACK 2</td>
            <td>Final ACK</td>
            <td>
                <ul>
                    <li>ACK Accepted</li>
                    <li>ACK Rejected</li>
                    <li>ACK Warning</li>
                </ul>
            </td>
        </tr>
        <tr>
            <td>ACK 3</td>
            <td><em>n/a</em></td>
            <td><em>n/a</em></td>
        </tr>
        <tr>
            <td>ACK 4</td>
            <td><em>n/a</em></td>
            <td><em>n/a</em></td>
        </tr>
    </tbody>
</table>

## MHRA

Set up ICSR submissions to the United Kingdom Medical and Healthcare products Regulatory Agency (UK MHRA) using the following information and links:

* **Reporting rules**: The <a href="/en/gr/01252/#ema">EMA ICSR Reporting Rule Set</a>
* **Jurisdiction**: The United Kingdom (Great Britain)
* **Report formats**: 
    * <a href="/en/gr/700007/">EMA E2B(R3)</a>
    * <a href="/en/gr/980119/">MHRA MIR XML</a>
* **AS2 Connection**: Configure the <a href="/en/gr/01454/">MHRA AS2 Connection</a> to communicate electronically with the MHRA.
* **Transmission Profile**: Set up the MHRA <a href="/en/gr/01202/">_Transmission Profile_</a>.

## NMPA

Set up ICSR submissions to the National Medical Products Administration (NMPA) using the following information and links:

* **Jurisdiction**: China
* **Report format**: <a href="/en/gr/823290/">NMPA E2B(R3)</a>
* **AS2 Connection**: Configure the <a href="/en/gr/01456/">NMPA AS2 Connection</a> to communicate electronically with the NMPA.
* **Transmission Profile**: Set up the NMPA <a href="/en/gr/01202/">_Transmission Profile_</a>.

### NMPA MDN and ACKs

Vault maps NMPA gateway responses to Vault response labels (ACK 1–4) and _Transmission_ lifecycle states:

<table>
    <thead>
        <tr>
            <th>Vault Response Label</th>
            <th>Agency Response Type</th>
            <th>Vault Lifecycle States</th>
        </tr>
    </thead>
    <tbody>
        <tr>
            <td>ACK 1</td>
            <td>MDN (Async MDN)</td>
            <td>MDN Received</td>
        </tr>
        <tr>
            <td>ACK 2</td>
            <td>Final ACK</td>
            <td>
                <ul>
                    <li>ACK Accepted</li>
                    <li>ACK Rejected</li>
                    <li>ACK Warning</li>
                </ul>
            </td>
        </tr>
        <tr>
            <td>ACK 3</td>
            <td><em>n/a</em></td>
            <td><em>n/a</em></td>
        </tr>
        <tr>
            <td>ACK 4</td>
            <td><em>n/a</em></td>
            <td><em>n/a</em></td>
        </tr>
    </tbody>
</table>

## PMDA

Set up ICSR submissions to the Pharmaceuticals and Medical Devices Agency (PMDA) using the following information and links:

* **Reporting rules**: The <a href="/en/gr/01252/#pmda">PMDA ICSR Reporting Rule Set</a>
* **Jurisdiction**: Japan
* **Report formats**:
  * <a href="/en/gr/700008/">PMDA E2B(R3)</a>
  * <a href="/en/gr/827489/">PMDA MHLW Paper Form</a>
  * PMDA postmarket device and regenerative medicine reporting:
      * <a href="/en/gr/1005171/">Form 8</a>
      * <a href="/en/gr/1005172/">Form 10</a>
      * <a href="/en/gr/1005173/">Form 13</a>
      * <a href="/en/gr/1005174/">Form 14</a>

* **AS2 Connection**: Configure the <a href="/en/gr/01455/">PMDA AS2 Connection</a> to communicate electronically with the PMDA.
* **Transmission Profile**: Set up the PMDA <a href="/en/gr/01202/">_Transmission Profile_</a>.

### PMDA MDN and ACKs

Vault maps PMDA gateway responses to Vault response labels (ACK 1–4) and <a href="/en/gr/01266/#transmission-lc-states">Transmission lifecycle states</a>:

<table>
    <thead>
        <tr>
            <th>Vault Response Label</th>
            <th>Agency Response Type</th>
            <th>Vault Lifecycle States</th>
        </tr>
    </thead>
    <tbody>
        <tr>
            <td>ACK 1</td>
            <td>MDN (Async MDN)</td>
            <td>MDN Received</td>
        </tr>
        <tr>
            <td>ACK 2</td>
            <td>Final ACK</td>
            <td>
                <ul>
                    <li>ACK Accepted</li>
                    <li>ACK Rejected</li>
                    <li>ACK Warning</li>
                </ul>
            </td>
        </tr>
        <tr>
            <td>ACK 3</td>
            <td><em>n/a</em></td>
            <td><em>n/a</em></td>
        </tr>
        <tr>
            <td>ACK 4</td>
            <td><em>n/a</em></td>
            <td><em>n/a</em></td>
        </tr>
    </tbody>
</table>

## VigiFlow

Vault supports submissions to VigiFlow. For information on configuring electronic communication, contact your VigiFlow representative.

* **Jurisdiction**: Based on your business process, assign VigiFlow jurisdiction over applicable countries. Vault supports submissions to VigiFlow for:
    * Argentina
    * Brazil
    * Columbia
    * Mexico
    * Turkey
* **Report format**: <a href="/en/gr/871674/">Vigiflow E2B(R3)</a>
* **Transmission Profile**: Based on your business process, set up <a href="/en/gr/01202/">_Transmission Profiles_</a> for electronic submissions.

## Other Agencies

Vault includes many inactive regulatory authority agencies. You can view these agencies by navigating to **Business Admin > Objects > Organizations** and filtering by the _Agency_ organization type. You can activate agencies or add <a href="/en/gr/01213/#add-a-custom-agency">custom _Agencies_</a>.

Set up ICSR submissions to other agencies using the following information and links:

* **Reporting rules**: Use custom reporting rules. To automatically generate regulatory _Submissions_ to an agency, assign a reporting rule set to the <a href="/en/gr/01253/">_Submission Rule_ field</a>  on the _Agency_ organization. <a href="/en/gr/01252/">Standard Reporting Rule Sets</a> describes the standard reporting rule sets that you can assign agencies.
* **Jurisdiction**: <a href="/en/gr/01213/#update-agency-country-jurisdiction">Assign agencies jurisdiction</a> over countries for which ICSR reporting is required. Vault supports submissions to:
    * Australia
    * Belarus
    * Russia
    * Saudi Arabia
    * Switzerland
* **Report formats**: In addition to the formats for the standard agencies described above, you can generate:
  * <a href="/en/gr/700009/">ICH E2B(R2)</a> or <a href="/en/gr/700005/">ICH E2B(R3)</a> file for global submissions
  * <a href="/en/gr/756509/">EU Convention E2B(R2)</a> file with regional data elements for international submissions, for example, TGA
  * <a href="/en/gr/01222/">CIOMS I</a>
  * Custom E2B formats using SDK to create the E2B+ file<sup><a href="#sdk-note">1</a></sup>. This feature supports calling an optional external E2B builder if required. Contact your Veeva Representative for help generating custom E2B formats.
* **AS2 Connection**: Configure a <a href="/en/gr/01458/">Custom AS2 Connection</a> for electronic AS2 communication with an agency.
* **Transmission Profile**: Set up the <a href="/en/gr/01202/">_Transmission Profiles_</a> for agencies to which you want to transmit electronic submissions.


<div class="note-border alert-info">
  <div class="alert alert-info" role="alert">
    <div><i class="far fa-info-circle"></i></div>
    <div class="alert-text">
      <p><strong>Note</strong>: 
<a id="sdk-note"></a>1. If you use a custom SDK to generate transmission documents, be aware that Vault sets the lifecycle state type of the associated <em>Transmission</em> to <em>Queued</em> instead of <em>Ready</em> as is the case for Vault-generated transmission documents.</p>
    </div>
  </div>
</div>



## Localization Scope {#localization-scope}

Admins can configure the <a href="/en/gr/01168/#localization-scope">scope of localization</a> for domestic _Case_ processing. When generating E2B files for domestic _Cases_, Vault considers the <a href="/en/gr/01194/#local-scope">_Localization Scope_</a> setting on the _Localization_. For example, if the _Localization Scope_ is _Narrative_ for a _Localization_, only the localized narrative content is exported on the E2B file. All other fields are English only.

## Back Reporting

Vault supports configurable <a href="/en/gr/01246/">back reporting</a> for any reporting destination, including agencies and licensed partners. Depending on your Admin's configuration, back reporting may be available only for certain reporting destinations.

[1]: #localization-scope