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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.
Note The NMPA AS2 Connection is an early adopter feature. If you create and configure an NMPA AS2 Connection in your Vault, you must test the Connection and ensure you receive an Acknowledge (ACK) signal from the NMPA Gateway to ensure the Connection is active.
Prerequisite: Activate NMPA as a Standard Organization
The NMPA is a standard Agency provided with Vault Safety. However, in certain Vaults, an Admin must activate the Agency record.
Complete the following steps if the NMPA is Inactive in your Vault:
- Go to Business Admin > Objects > Organizations.
- Open the NMPA (China) 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. Add User Action to the Organization Lifecycle provides instructions for this configuration.
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 registration process, you must obtain a public and private certificate pair and upload the public certificate to your NMPA account. If you need help generating these certificates, contact Veeva Managed Services.
Configure Sender User
For Submissions to the NMPA, you must enter full contact details for the Sender User. This user’s information will appear in generated forms and E2B files. The Sender User is assigned on Submission records in the Sender (User) field.
Manage Users provides more information on setting up user contact details.
Your Admin can configure the NMPA Transmission Profile to populate this field with a default Sender User on system-generated Transmissions based on the Transmission Profile.
Note If your organization is a CRO making Submissions on behalf of clients, you must complete each of the steps on this page separately for each sponsor, including setting up a new NMPA Account and obtaining new certificates per sponsor.
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.
Note For the NMPA, the Transmission Profile API Name is hard coded to ucr_china_gateway__c.
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, you need to add a Submission Rule Set to the Organization record by completing the following steps:
- Go to Business Admin > Objects > Organizations.
- On the Organizations page, select NMPA.
- On the NMPA page, select Edit.
- Under Details, in the Submission Rules field, select a standard Rule Set from the picklist.
- Select Save.
Note Reporting Rule Sets provides more information about the available Rule Sets. If these do not fulfill your requirements and you need a different Rule Set, contact your Veeva Managed Services representative.
Result
The system 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
- 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
Fields marked with a (*) are required.
| 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. |
| Description | Enter a description for the AS2 Connection. |
| Contact Email* | Enter the Sender’s Email |
| AS2 Additional ACK Stages |
Select from the following options:
|
| AS2 Compress Before Sign |
Select Yes if the system should compress messages before applying the Signing Algorithm.
Select No if the system should compress messages after applying the Signing Algorithm. |
| AS2 Encryption |
Select the algorithm the system uses to encrypt outbound AS2 messages and decrypt inbound messages. The system supports the following algorithms:
|
| AS2 MDN Setting | Select whether the Message Delivery Notification (MDN) can be exchanged synchronously (Sync) or asynchronously (Async). |
| AS2 Partner Certificate Expiry | The system automatically populates this field when an Admin uploads the Partner Certificate. |
| AS2 Partner 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 production or test NMPA account. |
| AS2 Partner URL | Enter the destination NMPA Gateway URL. |
| AS2 Signature |
Select the method the system uses to sign outbound AS2 messages. The system supports the following signing methods:
|
| AS2 Vault Certificate Expiry | The system automatically populates this field when an Admin uploads the Sponsor Certificate. |
| AS2 Vault Gateway State |
The system populates this field with the current state of the AS2 Vault Gateway.
|
| 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 <DOMAIN> with your unique domain name (for example, https://<DOMAIN>.gateway.veevavaultsafety.cn:4080 Note When setting up your AS2 account with NMPA, use the AS2 Vault URL you entered in this field, appended with the API path |
Upload the Partner and Sponsor Certificates
Vault Safety uses the Partner and Sponsor certificates to communicate securely with the Partner.
- Partner certificate: 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 Veeva Managed Services.
Upload Partner Certificate
- From the All Actions menu, select Upload Partner Certificate.
- Select Choose, then select the Partner’s Public Certificate.
Accepted formats: PKCS7 (.p7bor.p7c), DER (.ceror.der) and PEM (.cer,.crt, or.pem)
Note: Vault checks the expiry date of the certificate. If the certificate is no longer valid, you cannot save the record. - Select Continue.
Upload Sponsor Certificate
- From the All Actions menu, select Upload Sponsor Certificate.
- Select Choose, then select the Sponsor’s Public Certificate.
Accepted formats: PKCS12 (.pfxor.p12)
Note: Vault will check the expiry date of the certificate. If the certificate is no longer valid, you cannot save the record. - Select Continue.
Add Allowed Connections
Specify one (1) or more Allowed Connections for the AS2 Connection. These are Internet Protocol (IP) addresses that the system will allow to connect with this AS2 Connection. Perform the following steps for each Allowed Connection you want to add to the AS2 Connection.
- Go to the Connection Allowed Lists section, then select Create.
- Enter the Name, (optional) Description, and IP address of the Allowed Connection.
Ensure the format of the IP address isXX.XX.XX.XXorXX.XX.XX.XX/{subnet mask}where the{subnet mask}is a number between 24 and 32. - Repeat steps 1 and 2 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 Veeva Managed Services.
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 the system successfully completes this action, the Connection’s AS2 Vault Gateway State changes to Registered and the system can send and receive messages using this Connection.
Note If the Sync Connection to Gateway action is not successful, ensure the value of each of the AS2 Connection fields is correct before retrying the action again. If the issue perists, contact Veeva Managed Services.
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. The system cannot send or receive any messages using this Connection while it is in the 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.
