Configure NMPA AS2 Connection

Set up an AS2 Connection and Transmission Profile to support submissions through the NMPA Gateway.

About AS2 Connection Support for the NMPA Gateway

Vault Safety supports electronic reporting to the National Medical Products Administration (NMPA) through AS2 (system-to-system) communication.

You must set up an AS2 Connection and a corresponding Transmission Profile for users to report cases to the NMPA and receive gateway responses.

Prerequisite: Activate NMPA as a Standard Organization

The NMPA is a standard Agency provided with Vault Safety. However, in certain Vaults, your Admin must activate the Agency record.

Complete the following steps if the NMPA is inactive in your Vault:

  1. Go to Business Admin > Objects > Organizations.
  2. Open the NMPA (China) Agency record.
  3. From the All Actions menu, select Change State to Active.

Configure an NMPA Account

Before you can configure the Vault Safety AS2 Connection, you must have an active NMPA AS2 account.

Public and Private Certificates

As part of the NMPA registration process, you must obtain a public and private certificate pair and send the public certificate to the NMPA. If you need help generating these certificates, contact Veeva Managed Services.

Create an NMPA Transmission Profile

You must create a Transmission Profile of the type AS2 Gateway for the NMPA. Manage Transmission Profiles provides instructions on setting up Transmission Profiles.

Add a Submission Rule Set

Vault Safety comes preconfigured with the NMPA as a standard Organization. To define Case criteria for Submissions to the NMPA Gateway, add a Submission Rule Set to the Organization record by completing the following steps:

  1. Go to Business Admin > Objects > Organizations.
  2. On the Organizations page, select NMPA.
  3. On the NMPA page, select Edit.
  4. Under Details, in the Submission Rules field, select a standard Rule Set from the dropdown.
  5. Select Save.

Result

Vault can now auto-generate Submission records for ICSR Submissions to the NMPA based on the Rule Set you selected.

Configure a Vault Safety AS2 Connection

  1. Go to Admin > Connections, then select Create.
  2. For the Connection Type, select AS2, then select Continue.
  3. Complete the AS2 Connection Fields.
  4. 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.
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 NMPA, select Triple DES (3DES).
AS2 MDN Setting Whether the Message Delivery Notification (MDN) can be exchanged synchronously (Sync) or asynchronously (Async).
For the NMPA, 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 NMPA, select SHA-1.
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.

AS2 Partner ID

Enter one of the following NMPA identification codes:

  • For a production account, enter nmpacdr.
  • For a test account, enter nmpacdr_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 NMPA Gateway URLs:

  • For a production account, contact the NMPA to obtain the production NMPA Gateway URL.
  • For a test account, contact the NMPA to obtain the test NMPA 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 NMPA. This value is the same as the customer's Routing ID you provided when setting up your NMPA 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> = nmpa
  • <Environment> = validation
  • AS2 Vault URL = https://vernnmpavalidation.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://vernnmpavalidation.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 MPDA, 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.

Upload the Partner and Sponsor Certificates

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

  1. Go to Admin > Connections > [Connection].
  2. From the All Actions menu, select Upload Partner Certificate.
  3. 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.
  4. Select Continue.

Upload Sponsor Certificate

  1. Go to Admin > Connections > [Connection].
  2. From the All Actions menu, select Upload Sponsor Certificate.
  3. 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.
  4. 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.

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

  1. Go to Admin > Connections > [Connection].
  2. Go to the Connection Allowed Lists section, then select Create.
  3. 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.
  4. Repeat the above steps for each Allowed Connection.
  5. When you have added all the Allowed Connections, select Save.

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.

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.

Configure Transmission Lifecycles and Workflows

We recommend that you configure Transmission lifecycles and workflows to align with your organization’s standard operating procedures. The following items are best practices and recommendations:

  • Configure a Case Transmission Error workflow to handle Transmission errors.
  • Configure a workflow to prevent a Transmission record from entering a Ready for Submission state until a Transmission Profile is specified.

About Object Lifecycles and About Object Workflows provide more information about configuring lifecycles and workflows.