Configure PMDA AS2 Connection

Set up a Vault Safety PMDA AS2 Connection to support submissions through the PMDA Gateway.

About AS2 Connection Support for the PMDA Gateway

Vault 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. Vault Safety defines the Case criteria for these Submissions using the PMDA Rule Set.

Vault’s integration with the PMDA allows you to set up an AS2 Connection to submit ICSRs directly from Vault Safety and receive gateway responses.

Note: If your Vault currently uses the PMDA Gateway Profile to communicate with the PMDA, we recommend that you create an AS2 Connection to the PMDA as described in this article and then follow the instructions in Replace a Gateway Profile with an AS2 Connection.

Prerequisites

You must perform the following one-time configuration changes before you can set up PMDA Gateway submissions:

Activate PMDA as a Standard Organization
Enable PMDA E2B(R3) Export

Prerequisite: Activate PMDA as a Standard Organization

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:

Go to Business Admin > Objects > Organizations.
Open the PMDA Agency record.
From the All Actions menu, select Change State to Active.

Note: The Change State to Active user action appears only if configured by your Admin. Enable Regulatory Agencies as Standard Organizations provides instructions.

Apply for a PMDA Gateway Connection

Before you can configure the Vault Safety Gateway Profile, you must apply for a gateway connection between Vault Safety and the PMDA. The PMDA website 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. If you need help generating these certificates, contact Veeva Managed Services.

Complete the PMDA Connectivity Form

When you configure your PMDA Gateway connection, ensure that you complete the PMDA Connectivity Form from the PMDA website. Use the appropriate information in your AS2 Connection settings and the PMDA website, which provides the latest information available.

Note: To send AS2 messages to the PMDA, port 443 must be open. To receive AS2 messages from the PMDA, port 4080 must be open.

Add the Recipient User for PMDA Submissions

Vault Safety maps the Email Destination associated with the PMDA JP Transmission Profile when generating PMDA E2B(R3) files.

Go to Business Admin > Objects > Transmission Profiles.
Open the PMDA JP (jp_pmda__v) Gateway Profile.
In the Recipients section, select Create. If you do not see this section, you must insert the Recipients section on the layout.
In the Destination Person field, select the preconfigured Person record with the appropriate email address.
In the Recipient Type field, specify To.

Note: Before you can add an Email Destination, you must add a Person record for each recipient with the appropriate email address. Manage Person records from Business Admin > Objects > Persons.

Result

Vault 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.

Configure a Vault Safety AS2 Connection

Go to Admin > Connections, then select Create.
For the Connection Type, select AS2, then select Continue.
Complete the AS2 Connection Fields.
Select Save.

AS2 Connection Fields

Field	Description
Name	Enter a name for the AS2 Connection. This name must be unique in your Vault.
API Name	Enter an API Name for the AS2 Connection. This name must be unique in your Vault.
Contact Email	Enter the Sender's Email.
Description	Enter a description for the AS2 Connection.
AS2 Vault Gateway State	Vault populates this field with the current state of the AS2 Vault Gateway, which consists of one (1) of the following options: Unregistered: The Sync to Gateway action has not yet been run for this AS2 Connection. Registered: The AS2 Connection is synchronized with the Gateway. Out of Sync: Changes have been made to the AS2 Connection or its Connection Allowed List since the last time the Sync to Gateway action was run. From the All Actions menu, select Sync To Gateway to resync the AS2 Connection with the Gateway.
AS2 Additional ACK Stages	If required, select one (1) or more of the following options: HTTP Handshake: Used primarily for asynchronous requests. PRE-ACK: Used mainly for FDA VAERS, but can be used with synchronous or asynchronous requests. Note: We do not recommend using any additional ACK stages.
AS2 Encryption	The algorithm Vault uses to encrypt outbound AS2 messages and decrypt inbound messages. Vault supports the following algorithms: Triple DES (3DES) AES-256-GCM AES-256-CBC For the PMDA, select AES-256-CBC.
AS2 MDN Setting	Whether the Message Delivery Notification (MDN) can be exchanged synchronously (Sync) or asynchronously (Async). For the PMDA, select Sync.
AS2 Signature	The method Vault uses to sign outbound AS2 messages. Vault supports the following signing methods: SHA-1 SHA-256 For the PMDA, select SHA-256.
AS2 Compress Before Sign	If you select this option, Vault compresses messages before applying the Signing Algorithm. If you do not select this option, Vault compresses messages after applying the Signing Algorithm. Note: We recommend leaving this option unselected.
AS2 Partner ID	Enter one of the following PMDA identification codes: For a production account, contact the PMDA to obtain the PMDA Partner ID. For a test account, enter `re-test`. Whether you are submitting Study or postmarket Cases, enter one (1) of these values. You can specify the destination gateway endpoint in the Transmission Profile.
AS2 Partner URL	Enter one (1) of the following destination PMDA Gateway URLs: For a production account, contact the PMDA to obtain the production PMDA Gateway URL. For a test account, contact the PMDA to obtain the test PMDA Gateway URL.
AS2 Partner Certificate Expiry	Vault automatically populates this field when your Admin uploads the Partner Certificate.
AS2 Vault ID	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.
AS2 Vault URL	Enter the AS2 URL of your Vault in the following format, replacing `<SponsorName><Partner><Environment>` with the corresponding values of your Vault: `https://<SponsorName><Partner><Environment>.gateway.veevavaultsafety.com:4080` The following example demonstrates how to form the AS2 Vault URL for a Vault with the following values: `<SponsorName>` = vern `<Partner>` = pmda `<Environment>` = validation AS2 Vault URL = `https://vernpmdavalidation.gateway.veevavaultsafety.com:4080` Informing the Partner of your AS2 Vault URL When informing the Partner of the URL they need to use for this AS2 connection, use the value you entered in this field appended with `/api/v1/inbound/transmission/`. In the example shown above, this is `https://vernpmdavalidation.gateway.veevavaultsafety.com:4080/api/v1/inbound/transmission/`.
AS2 Vault Certificate Expiry	Vault automatically populates this field when your Admin uploads the Sponsor Certificate.
AS2 Vault Domain / IP Configuration	Select the method the Partner uses to interface with the AS2 Connection. AS2 Vault URL: Domain Name (typical): A standard domain name that resolves to dynamic IP addresses. AS2 Vault URL: Domain Name bound to static IP addresses: A standard domain name that resolves to static IP addresses. AS2 Vault URL: IP URL (uncommon): A non-standard IP address domain name that resolves to an IP address. For the PMDA, select AS2 Vault URL: Domain Name (typical).
AS2 Ingress IPs	If you set the AS2 Vault Domain / IP Configuration field to AS2 Vault URL: Domain Name bound to static IP addresses, Vault populates this field automatically.

Vault Safety uses the Partner and Sponsor certificates to communicate securely with the Partner.

You will have received the Partner certificate as part of creating your account with the Partner.

If you need help generating a Sponsor certificate, contact your Veeva Representative.

Upload Partner Certificate

Go to Admin > Connections > [Connection].
From the All Actions menu, select Upload Partner Certificate.
Select Choose, then select the Partner’s Public Certificate.
The following accepted formats are:
- PKCS7 (.p7b or .p7c)
- DER (.cer or .der)
- PEM (.cer, .crt, or .pem)
  Vault checks the expiry date of the certificate. If the certificate is no longer valid, you cannot save the record.
Select Continue.

Go to Admin > Connections > [Connection].
From the All Actions menu, select Upload Sponsor Certificate.
Select Choose, then select the Sponsor’s Public Certificate.
The accepted formats are PKCS12 (.pfx or .p12)
Vault checks the expiry date of the certificate. If the certificate is no longer valid, you cannot save the record.
Select Continue.

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.

Note: To obtain the latest list of allowed connections for the PMDA, contact your Veeva Representative.

Perform the following steps for each Allowed Connection you want to add to the AS2 Connection:

Go to Admin > Connections > [Connection].
Go to the Connection Allowed Lists section, then select Create.
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.
Repeat the above steps for each Allowed Connection.
When you have added all the Allowed Connections, select Save.

Note: By default, Vaults are limited to 512 Allowed Connections. If your organization requires more, contact your Veeva Representative.

Synchronize the 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 changes to Registered and Vault can send and receive messages using this Connection.

Note: If the Sync Connection to Gateway action is not successful, ensure each field value on the AS2 Connection is correct before retrying the action again. If the issue persists, contact your Veeva Representative.

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.

Configure the PMDA Transmission Profile

Vault 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.

Manage Transmission Profiles 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.

Note: The Routing ID should be ‘PMDA’. Do not edit this value.

Once you set up the PMDA Transmission Profile, Vault uses the appropriate Transmission Profile to generate Submissions based on your Vault’s reporting rules for PMDA.