# Configure PMDA AS2 Connection

Safety supports the Japan Pharmaceuticals and Medical Devices Agency (PMDA) Gateway through AS2 (system-to-system) communication. The PMDA Gateway can be used for ICSR submissions to the PMDA in the PMDA E2B(R3) file format. Safety defines the _Case_ criteria for these _Submissions_ using the _PMDA ICSR Reporting Rule Set_.

Vault's integration with the PMDA allows you to set up an <a href="/en/gr/703946/">_AS2 Connection_</a> to submit ICSRs directly from Safety and receive gateway responses.



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      <p><strong>Note</strong>: If your Vault currently uses the <a href="/en/gr/01209/">PMDA <em>Gateway Profile</em></a> to communicate with the PMDA, we recommend that you <a href="#create-as2-connection">create an <em>AS2 Connection</em> to the PMDA</a> as described in this article and then follow the instructions in <a href="/en/gr/01460/">Replace a Gateway Profile with an AS2 Connection</a>.</p>
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## Prerequisites

In addition to enabling <a href="/en/gr/01459/">AS2 Connections</a>, you must perform the following one-time configuration changes before you can set up PMDA Gateway submissions:

* [Activate the PMDA _Agency_ as a Standard _Organization_][1]
* <a href="/en/gr/01366/">Enable PMDA E2B(R3) Export</a>

### Prerequisite: Activate PMDA as a Standard Organization {#activate-pmda-org}

PMDA comes preconfigured in each Vault as a standard _Organization_. In certain Vaults, an Admin must make the _Agency_ active before you can set up PMDA Gateway submissions.

If PMDA is Inactive in your Vault, your Admin must complete the following steps:

1. Navigate to **Business Admin > Objects > Organizations**.
2. Open the **PMDA** _Agency_ record.
3. From the **All Actions** menu, select **Change State to Active**.


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      <p><strong>Note</strong>: 
The <strong>Change State to Active</strong> user action appears only if configured by your Admin. <a href="/en/gr/01433/#add-user-action-to-the-organization-lifecycle-inactive-state">Enable Regulatory Agencies as Standard Organizations</a> provides instructions.</p>
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## Apply for a PMDA Gateway Connection

Before you can configure the Safety _AS2 Connection_, you must apply for a gateway connection between Veeva Safety and the PMDA. The <a class="external-link " href="https://skw.info.pmda.go.jp/notice/e2br3_index.html" target="_blank" rel="noopener">PMDA website<i class="fa fa-external-link" aria-hidden="true"></i></a> provides instructions for setting up the gateway registration.

### Public and Private Certificates

As part of the PMDA registration process, you must obtain a public and private certificate pair and send the public certificate to the PMDA.
Your Admin can <a href="/en/gr/872385/#create-sponsor-cert">create these certificates within Vault</a>.


### Complete the PMDA Connectivity Form

When you configure your PMDA Gateway connection, ensure that you complete the PMDA Connectivity Form from the <a class="external-link " href="https://skw.info.pmda.go.jp/notice/e2br3_index.html#4" target="_blank" rel="noopener">PMDA website<i class="fa fa-external-link" aria-hidden="true"></i></a>. Use the appropriate information in your <a href="#create-as2-connection">_AS2 Connection_</a> settings and the PMDA website, which provides the latest information available.

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      <p><strong>Note</strong>: To send AS2 messages to the PMDA, port 443 must be open. To receive AS2 messages from the PMDA, port 4080 must be open.</p>
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## Add the Recipient User for PMDA Submissions

Safety maps the Email Destination associated with the PMDA JP _Transmission Profile_ when generating PMDA E2B(R3) files.

1. Navigate to **Business Admin > Objects > Transmission Profiles**.
2. Open the **PMDA JP** (`jp_pmda__v`) _Transmission Profile_.
3. In the **Recipients** section, select **Create**. If you do not see this section, you must <a href="/en/gr/01366/#update-transmission-profile-layout">insert the **Recipients** section on the layout</a>.
4. In the **Destination Person** field, select the preconfigured **Person** record with the appropriate email address.
5. In the **Recipient Type** field, specify **To**.

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      <p><strong>Note</strong>: Before you can add an Email Destination, you must add a <strong>Person</strong> record for each recipient with the appropriate email address. Manage <strong>Person</strong> records from <strong>Business Admin &gt; Objects &gt; Persons</strong>.</p>
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**Result**

Safety uses the contact information for the referenced Person to populate E2B elements J2.18.2 to J2.18.4 in PMDA E2B(R3) exports.


## <a id="create-as2-connection"></a> Configure a Safety AS2 Connection

1. Navigate to **Admin > Connections**, then select **Create**.
2. For the **Connection Type**, select **AS2**, then select **Continue**.
3. Complete the applicable <a href="#as2-connection-fields">fields</a>.
4. Select **Save**.

### AS2 Connection Fields {#as2-connection-fields}

With the exception of <a href="#transfer-fields">_Transfer Connection_</a> fields and fields populated by Vault, complete all fields in the following sections:

* <a href="#details-fields">AS2 Details Fields</a>
* <a href="#partner-fields">AS2 Partner Details Fields</a>
* <a href="#sponsor-fields">AS2 Sponsor Details Fields</a>

#### AS2 Details Fields {#details-fields}

<table>
    <thead>
        <tr>
            <th>
                Field
            </th>
            <th>
                Description
            </th>
        </tr>
    </thead>
    <tbody>
        <tr>
            <td>
                <em>Name</em>
            </td>
            <td>
                Enter a name for the <em>AS2 Connection</em>.<br>
                This name must be unique in your Vault.
            </td>
        </tr>
        <tr>
            <td>
                <em>API Name</em>
            </td>
            <td>
                Enter an API Name for the <em>AS2 Connection</em>.<br>
                This name must be unique in your Vault.<br>
            </td>
        </tr>
        <tr>
            <td>
                <em>Description</em>
            </td>
            <td>
                Enter a description for the <em>AS2 Connection</em>.
            </td>
        </tr>
        <tr>
            <td>
                <em>Contact Email</em>
            </td>
            <td>
                Enter the Sender's Email.
            </td>
        </tr>
        <tr>
            <td>
                <em>AS2 Vault Gateway State</em><a id="as2-vault-gateway-state"></a>
            </td>
            <td>
                Vault populates this field with the current state of the AS2 Vault Gateway, which consists of one (1) of the following options:
                <ul>
                    <li>
                        <strong>Unregistered</strong>: The <strong>Sync to Gateway</strong> action has not yet been run for this <em>AS2 Connection</em>.
                    </li>
                    <li>
                        <strong>Registered</strong>: The <em>AS2 Connection</em> is synchronized with the Gateway.
                    </li>
                    <li>
                        <strong>Out of Sync</strong>: Changes have been made to the <em>AS2 Connection</em> or its Connection Allowed List since the last time the <strong>Sync to Gateway</strong> action was run. From the <strong>All Actions</strong> menu, select <strong>Sync To Gateway</strong> to resync the <em>AS2 Connection</em> with the Gateway.
                    </li>
                </ul>
            </td>
        </tr>
        <tr>
            <td>
                <em>AS2 Encryption</em>
            </td>
            <td>
                The algorithm Vault uses to encrypt outbound AS2 messages and decrypt inbound messages.<br>Vault supports the following algorithms:
                <ul>
                    <li>Triple DES (3DES)</li>
                    <li>AES-256-GCM</li>
                    <li>AES-256-CBC</li>
                </ul>
                
                        For the PMDA, select <strong>AES-256-CBC</strong>.
                    
            </td>
        </tr>
        <tr>
            <td>
                <em>AS2 MDN Setting</em>
            </td>
            <td>
                Whether the Message Delivery Notification (MDN) can be exchanged synchronously (<strong>Sync</strong>) or asynchronously (<strong>Async</strong>).<br>
                
                        For the PMDA, select <strong>Sync</strong>.
                    
            </td>
        </tr>
        <tr>
            <td>
                <em>AS2 Signature</em>
            </td>
            <td>
                The method Vault uses to sign outbound AS2 messages. Vault supports the following signing methods:
                <ul>
                    <li>SHA-1</li>
                    <li>SHA-256</li>
                </ul>
                
                        For the PMDA, select <strong>SHA-256</strong>.
                    
            </td>
        </tr>
        <tr>
            <td>
                <em>AS2 Additional ACK Stages</em>
            </td>
            <td>
                If required, select one (1) or more of the following options:
                <ul>
                    <li>
                        <strong>HTTP Handshake</strong>: Used primarily for asynchronous requests.
                    </li>
                    <li>
                        <strong>PRE-ACK</strong>: Used mainly for FDA VAERS, but can be used with synchronous or asynchronous requests.
                    </li>
                </ul>
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      <p><strong>Note</strong>: We do not recommend using any additional ACK stages.</p>
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            </td>
        </tr>
        <tr>
            <td>
                <em>AS2 Partner Sends ACK on MDN URL</em><a id="partner-ack-on-mdn-url"></a>
            </td>
            <td>
                <p>
                    The default setting for this field is <em>No</em>, as Vault expects an AS2 partner to send the ACK using a different URL than that used to send the MDN.
                </p>
                <p>
                
                        Select <strong>No</strong>.
                
                </p>
                <p>
                    For more information about AS2 gateway communications, see <a href="/en/gr/01266/#what-is-as2-gateway-communication">Send a Gateway Transmission</a>.
                </p>
            </td>
        </tr>
        <tr>
            <td>
                <em>AS2 Compression Settings</em><a id="as2-compression-settings"></a>
            </td>
            <td>
                
                        For the PMDA, select <strong>Compress After Sign (Standard)</strong>.
                    
            </td>
        </tr>
    </tbody>
</table>

#### AS2 Partner Details Fields {#partner-fields}

<table>
    <thead>
        <tr>
            <th>
                Field
            </th>
            <th>
                Description
            </th>
        </tr>
    </thead>
    <tbody>
        <tr>
            <td>
                <em>AS2 Partner ID</em>
            </td>
            <td>
                
                        <p>
                            Enter one of the following PMDA identification codes:
                        </p>
                        <ul>
                            <li>For a production account, contact the PMDA to obtain the PMDA partner ID.</li>
                            <li>For a test account, enter <code>re-test</code></li>
                        </ul>
                        <p>
                            Whether you are submitting <em>Study</em> or postmarket <em>Cases</em>, enter one (1) of these values. This value cannot include spaces. Instead, use a hyphen (<code>-</code>) or an underscore (<code>_</code>). You can specify the destination gateway endpoint in the <em>Transmission Profile</em>.
                        </p>
                    
            </td>
        </tr>
        <tr>
            <td>
                <em>AS2 Partner URL</em>
            </td>
            <td>
                
                        <p>
                            Enter one (1) of the following destination PMDA Gateway URLs:
                        </p>
                        <ul>
                            <li>
                                For a production account, contact the PMDA to obtain the production PMDA Gateway URL.
                            </li>
                            <li>
                                For a test account, contact the PMDA to obtain the test PMDA Gateway URL.
                            </li>
                        </ul>
                    
            </td>
        </tr>
        <tr>
            <td>
                <em>AS2 Partner Certificate Expiry</em>
            </td>
            <td>
                Vault populates this field when your Admin <a
                href="#upload-certificates">uploads the partner certificate</a>.
            </td>
        </tr>
        <tr>
            <td>
                <em>AS2 Partner Certificate Serial Number</em>
            </td>
            <td>
                When you upload a new partner certificate for this connection, Vault sets this field to the Serial Number of the certificate in decimal format.
            </td>
        </tr>
    </tbody>
</table>

#### AS2 Sponsor Details Fields {#sponsor-fields}

<table>
    <thead>
        <tr>
            <th>
                Field
            </th>
            <th>
                Description
            </th>
        </tr>
    </thead>
    <tbody>
        <tr>
            <td>
                <em>AS2 Vault ID</em>
            </td>
            <td>
                
                      Enter the sponsor ID registered with the PMDA. This value is the same as the customer's Routing ID you provided when setting up your production or test PMDA account. This value cannot include spaces. Instead, use a hyphen (<code>-</code>) or an underscore (<code>_</code>).
                    
            </td>
        </tr>
        <tr>
            <td>
                <a id="as2-vault-url"></a>
                <em>AS2 Vault URL</em>
            </td>
            <td>
                
                <p>
                    Enter the AS2 URL of your Vault in the following format, replacing <code>&lt;SponsorName&gt;&lt;Partner&gt;&lt;Environment&gt;</code> with the corresponding values of your Vault:
                </p>
                <p>
                    <code>https://&lt;SponsorName&gt;&lt;Partner&gt;&lt;Environment&gt;.gateway.veevavaultsafety.com:4080</code>
                </p>
                <p>
                    The following example demonstrates how to form the AS2 Vault URL for a Vault with the following values:
                </p>
                <ul>
                    <li><code>&lt;SponsorName&gt;</code> = vern</li>
                    <li><code>&lt;Partner&gt;</code> = pmda</li>
                    <li><code>&lt;Environment&gt;</code> = validation</li>
                    <li>AS2 Vault URL = <code>https://vernpmdavalidation.gateway.veevavaultsafety.com:4080</code></li>
                </ul>
                <p>
                    <strong>Informing the Partner of your AS2 Vault URL</strong>
                </p>
                <p>
                    When informing the partner of the URL they need to use for this <em>AS2 Connection</em>, use the value you entered in this field appended with <code>/api/v1/inbound/transmission</code>
                </p>
                <p>
                    In the example shown above, this is <code>https://vernpmdavalidation.gateway.veevavaultsafety.com:4080/api/v1/inbound/transmission</code>
                </p>
                
            </td>
        </tr>
        <tr>
            <td>
                <em>AS2 Vault Certificate Expiry</em>
            </td>
            <td>
                Vault populates this field when your Admin <a
                href="#upload-certificates">uploads the sponsor certificate</a>.
            </td>
        </tr>
        <tr>
            <td>
                <em>AS2 Vault Certificate Serial Number</em>
            </td>
            <td>
                When you upload a new sponsor certificate for this connection, Vault sets this field to the Serial Number of the certificate.
            </td>
        </tr>
        <tr>
            <td>
                <a id="as2-vault-domain-ip-config"></a>
                <em>AS2 Vault Domain / IP Configuration</em>
            </td>
            <td>
                <p>
                    Select the method the partner uses to interface with the <em>AS2 Connection</em>.
                </p>
                <ul>
                    <li><strong>AS2 Vault URL: Domain Name (typical)</strong>: A standard domain name that resolves to dynamic IP addresses.</li>
                    <li><strong>AS2 Vault URL: Domain Name bound to static IP addresses</strong>: A standard domain name that resolves to static IP addresses.</li>
                    <li><strong>AS2 Vault URL: IP URL (uncommon)</strong>: A non-standard IP address domain name that resolves to an IP address.</li>
                </ul>
                
                      For the PMDA, select <strong>AS2 Vault URL: Domain Name (typical)</strong>.
                    
            </td>
        </tr>
    </tbody>
</table>

#### Transfer Connection Fields {#transfer-fields}

Leave the fields in this section blank.


### Upload the Partner and Sponsor Certificates {#upload-certificates}

Safety uses
<a href="/en/gr/872385/">partner and sponsor certificates</a>
to communicate securely with the partner. You will have received the partner certificate as part of creating your account with the partner.

Complete the following steps to create and upload these certificates:
* <a href="/en/gr/872385/#upload-partner-cert">Upload the partner certificate for the connection</a>.
* <a href="/en/gr/872385/#create-sponsor-cert">Create a sponsor certificate for the connection</a>.

### Add Connection Allowed IPs

Specify one (1) or more Allowed Connections for the _AS2 Connection_. These are Internet Protocol (IP) addresses that Vault will allow to connect with this _AS2 Connection_.

Perform the following steps for each Allowed Connection you want to add to the _AS2 Connection_:

1. Navigate to **Admin > Connections > [Connection] > Connection Allowed Lists**, then select **Create**.
2. On the **Create Connection Allowed List** window, complete the following information:
  * **Name**: Enter a name for the Allowed Connection.
  * (Optional) **Description**: Enter a description for the Allowed Connection.
  * **IP**: Enter the address of the Allowed Connection. \
  Ensure the format of the **IP** address is `XX.XX.XX.XX` or `XX.XX.XX.XX/{subnet mask}` where the `{subnet mask} `is a number between 24 and 32.
3. Repeat the above steps for each Allowed Connection.
4. When you have added all the Allowed Connections, select **Save**.

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      <p><strong>Note</strong>: By default, Vaults are limited to 512 Allowed Connections. If your organization requires more, contact your Veeva Representative.</p>
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### Synchronize the Connection {#sync-as2-connection}

Once you have entered all the details of the _AS2 Connection_, the Connection must be synchronized with the Gateway.

From the **All Actions** menu, select **Sync Connection to Gateway**.

When Vault successfully completes this action, the Connection's [AS2 Vault Gateway State](#as2-vault-gateway-state) changes to **Registered** and Vault can send and receive messages using this Connection.

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      <p><strong>Note</strong>: If the <em>Sync Connection to Gateway</em> action is not successful, ensure each field value on the <em>AS2 Connection</em> is correct before retrying the action again. If the issue persists, <a href="/en/gr/728014/">troubleshoot the connection</a>.</p>
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If you make any changes to the **Connection** object or its Connection Allowed List, the **AS2 Vault Gateway State** changes to **Registered - Out of Sync**. Vault cannot send or receive any messages using this Connection while it is in the **Registered - Out of Sync** state. You will need to repeat the **All Actions > Sync to Gateway** action to restore the Connection to the **Registered** state.


**Result**

The PMDA _AS2 Connection_ is active and available to use to submit case reports to the PMDA.

## <a id="configure-the-PMDA-transmission-profile"></a>Configure the PMDA Transmission Profile

Safety has a system-provided **PMDA** _Transmission Profile_ for electronic PMDA _Submissions_. You must configure this _Transmission Profile_ as part of the PMDA Gateway setup.

<a href="/en/gr/01202/">Manage Transmission Profiles</a> provides instructions on setting up _Transmission Profiles_.

When setting up the _Transmission Profiles_, see the following guidance on setting the _Origin_ and _Destination IDs_:

* **Origin ID**: Enter the ID registered with the PMDA, typically your D-U-N-S number. This value is the same as the customer's Routing ID you provided when setting up your PMDA account.
* **Destination ID**: Enter `PMDA`.

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      <p><strong>Note</strong>: The Routing ID should be ‘PMDA’. Do not edit this value.</p>
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Once you set up the PMDA _Transmission Profile_, Vault uses the appropriate _Transmission Profile_ to generate _Submissions_ based on your Vault's <a href="/en/gr/01252/#pmda">reporting rules</a> for PMDA.

[1]: #activate-pmda-org