Sections in This Article
FDA
The following sections provide an overview of how to set up ICSR submissions to the FDA, with links to articles for more information.
FDA Reporting Rules
FDA submissions are evaluated with the FDA ICSR Reporting Rule Set. Studies and suspect or interacting Case Products with registrations in a country within the FDA’s jurisdiction trigger reporting rules to evaluate submissions to the FDA.
FDA Jurisdiction
The FDA is assigned jurisdiction over the following countries in the standard Vault Safety template:
- 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.)
However, administrators can configure different countries to which the FDA is assigned jurisdiction. Confirm the settings in your vault by going to Business Admin > Organizations and viewing the Jurisdictions listed under the FDA.
FDA Report Formats
The following table outlines the FDA report formats that Vault Safety generates. The links in the Format column describe how the system maps Case data to generate these reports:
| Submission Type | Format |
|---|---|
| Biologics (CBER) | FDA E2B (R2) |
| Drugs (CDER) | FDA E2B (R2) |
| Vaccines (VAERS) | FDA VAERS E2B (R3) |
| Studies | FDA MedWatch 3500A |
FDA Gateways
There are two gateway AS2 endpoints you can configure for electronic communications with the FDA. Configure FDA Gateway provides instructions on configuring these gateways:
| Gateway Endpoint | Usage |
|---|---|
| US FDA ESG | For CDER (drugs) or CBER (biologics) submissions |
| US FDA CBER VAERS | For VAERS CBER (vaccines) submissions |
FDA Transmission Profiles
There are multiple Transmission Profiles for the FDA:
| Transmission Profile | Usage |
|---|---|
| CBER | Configure this Transmission Profile for ICSR transmissions to the Center for Biologics Evaluation and Research (CBER) with the US FDA ESG gateway. |
| CDER | Configure this Transmission Profile for ICSR transmissions to the Center for Drug Evaluation and Research (CDER) with the US FDA ESG gateway. |
| GWTEST | Configure this Transmission Profile for test transmissions with the US FDA ESG gateway. |
| CBER VAERS | Configure this Transmission Profile for VAERS ICSR transmissions to the Center for Biologics Evaluation and Research (CBER) with the US FDA CBER VAERS gateway. |
| FDA Study | Because the FDA does not currently accept E2B Gateway submissions for ICSRs in a clinical study, configure this Transmission Profile to generate and manage manual submissions of the FDA MedWatch 3500A form. |
FDA MDN and ACKs
The following tables describe how Vault Safety maps FDA gateway responses to Vault Safety response labels (ACK 1–4) and Transmission lifecycle states.
FDA FAERS
| Vault Safety Response Label | Agency Response Type | Vault Lifecycle States |
|---|---|---|
| ACK 1 | MDN (Sync MDN) | MDN Received |
| ACK 2 | Final ACK |
|
| ACK 3 | n/a | n/a |
| ACK 4 | n/a | n/a |
See Troubleshoot FDA Gateway Submissions for help resolving FDA E2B(R2) issues.
FDA VAERS
| Vault Safety Response Label | Agency Response Type | Vault Lifecycle States |
|---|---|---|
| ACK 1 | Handshake | No state change |
| ACK 2 | MDN (Async MDN) | MDN Received |
| ACK 3 | ACK 2 | No state change |
| ACK 4 | Final ACK |
|
EMA
The following sections provide an overview of how to set up ICSR submissions to the EMA, with links to articles for more information.
EMA Reporting Rules
EMA submissions are evaluated with the EMA ICSR Reporting Rule Set. Studies and suspect or interacting Case Products with registrations in a country within the EMA’s jurisdiction trigger reporting rules to evaluate submissions to the EMA.
EMA Jurisdiction
The EMA is assigned jurisdiction over the following countries in the standard Vault Safety template:
- Austria
- Belgium
- Bulgaria
- Croatia
- Cyprus
- Czechia
- Denmark
- Estonia
- Europe
- Finland
- France
- Germany
- Greece
- Hungary
- Iceland
- Ireland
- Italy
- Latvia
- Liechtenstein
- Lithuania
- Luxembourg
- Malta
- Netherlands (the)
- Norway
- Poland
- Portugal
- Romania
- Slovakia
- Slovenia
- Spain
- Sweden
- United Kingdom (Northern Ireland)
However, administrators can configure different countries to which the EMA is assigned jurisdiction. Confirm the settings in your vault by going to Business Admin > Organizations and viewing the Jurisdictions listed under the EMA.
EMA Report Format
Submissions to the EMA generate reports in the EMA E2B (R3) format.
EMA Gateway
Vault Safety supports electronic reporting to EudraVigilance for electronic communications with the EMA. Configure EMA Gateway provides instructions on configuring this gateway.
EMA Transmission Profiles
There are two Transmission Profiles for the EMA:
| Transmission Profile | Usage |
|---|---|
| EVCTMPROD | Configure this Transmission Profile for submissions to the EudraVigilance Clinical Trial Module (EVCTM). |
| EVHUMAN | Configure this Transmission Profile for submissions to the EudraVigilance Post-Authorisation Module (EVPM). |
EMA MDN and ACKs
The following table describes how Vault Safety maps EMA gateway responses to Vault Safety response labels (ACK 1–4) and Transmission lifecycle states:
| Vault Safety Response Label | Agency Response Type | Vault Lifecycle States |
|---|---|---|
| ACK 1 | Handshake | No state change |
| ACK 2 | MDN (Async MDN) | MDN Received |
| ACK 3 | Final ACK |
|
| ACK 4 | n/a | n/a |
See Troubleshoot EMA Gateway Submissions for help resolving EMA E2B(R3) issues.
MHRA
The following sections provide an overview of how to set up ICSR submissions to the MHRA, with links to articles for more information.
MHRA Reporting Rules
Submissions are evaluated using the MHRA Rule Set, which is based off of the EMA ICSR Reporting Rule Set. Studies and suspect or interacting Case Products with registrations in the United Kingdom (Great Britain) trigger reporting rules to evaluate submissions to the MHRA.
MHRA Jurisdiction
The EMA is assigned jurisdiction over the United Kingdom (Great Britain) in the standard Vault Safety template.
However, administrators can configure different countries to which the MHRA is assigned jurisdiction. Confirm the settings in your vault by going to Business Admin > Organizations and viewing the Jurisdictions listed under the MHRA.
MHRA Report Format
Submissions to the MHRA generate reports in the EMA E2B (R3) format.
MHRA Gateway
Vault Safety supports electronic communication with the United Kingdom Medical and Healthcare products Regulatory Agency (UK MHRA). Configure MHRA Gateway provides instructions on configuring this gateway.
MHRA Transmission Profile
Set up the MHRA Transmission Profile for electronic submissions.
PMDA
The following sections provide an overview of how to set up ICSR submissions to the PMDA, with links to articles for more information.
PMDA Reporting Rules
PMDA submissions are evaluated with the PMDA ICSR Reporting Rule Set. Studies and suspect or interacting Case Products with registrations in Japan trigger reporting rules to evaluate submissions to the PMDA.
PMDA Jurisdiction
The PMDA is assigned jurisdiction over Japan in the standard Vault Safety template.
However, administrators can configure different countries to which the PMDA is assigned jurisdiction. Confirm the settings in your vault by going to Business Admin > Organizations and viewing the Jurisdictions listed under the PMDA.
PMDA Report Format
Submissions to the PMDA generate reports in the PMDA E2B(R3) format.
PMDA Gateway
Vault Safety supports electronic communication with the Japan Pharmaceuticals and Medical Devices Agency (PMDA). Configure PMDA Gateway provides instructions on configuring this gateway.
PMDA Transmission Profile
Set up the PMDA Transmission Profile for electronic submissions.
PMDA MDN and ACKs
The following table describes how Vault Safety maps PMDA gateway responses to Vault Safety response labels (ACK 1–4) and Transmission lifecycle states:
| Vault Safety Response Label | Agency Response Type | Vault Lifecycle States |
|---|---|---|
| ACK 1 | MDN (Async MDN) | MDN Received |
| ACK 2 | Final ACK |
|
| ACK 3 | n/a | n/a |
| ACK 4 | n/a | n/a |
Health Canada
The following sections provide an overview of how to set up ICSR submissions to Health Canada, with links to articles for more information.
Health Canada Reporting Rules
Vault Safety does not currently have a designated rule set for Health Canada. However, you can use the FDA ICSR Reporting Rule Set as a basic starting point. Health Canada may be assigned this rule set already in certain vaults. If you require a custom rule set, contact Veeva Managed Services for assistance.
Note By default, back reporting is turned on for reports received from Health Canada.
Health Canada Jurisdiction
The Health Canada is assigned jurisdiction over Canada in the standard Vault Safety template.
However, administrators can configure different countries to which Health Canada is assigned jurisdiction. Confirm the settings in your vault by going to Business Admin > Organizations and viewing the Jurisdictions listed under Health Canada.
Health Canada Report Format
Submissions to Health Canada generate reports in the HC E2B (R2) format.
Health Canada Gateway
Vault Safety supports electronic communication with the Canada Vigilance Program (CVP). Configure Health Canada Gateway provides instructions on configuring this gateway.
Note Because Health Canada does not allow testing with 3rd party vendors, their gateway has not been vendor tested with Vault Safety. You must perform additional testing when setting up Health Canada electronic submissions. Contact Veeva Managed Services for assistance.
Health Canada Transmission Profile
There are two Transmission Profiles for Health Canada:
| Transmission Profile | Usage |
|---|---|
| HC MHPD | For submitting postmarket reports to the Health Canada’s Marketed Health Products Directorate (MHPD). |
| HC TPD | For submitting clinical trial reports to the Health Canada's Therapeutic Products Directorate (TPD). |
Other Agencies
Vault Safety comes with many inactive regulatory authority agencies out-of-box. You can view these agencies by going to Business Admin > Organizations, and filtering by the Agency organization type. You can activate agencies or add custom Agencies.
The following sections provide an overview of how to set up ICSR submissions to different agencies, with links to articles for more information.
Custom Reporting Rules
To automatically generate regulatory Submissions to an agency, assign a reporting rule set to the Submission Rule field on the Agency Organization.
Reporting Rule Sets describes the standard reporting rule sets that you can assign agencies.
Other Agency Jurisdictions
You can assign agencies jurisdiction over countries for which ICSR reporting is required.
If you selected a Submission Rule for the Agency, Cases with Products or Studies registered to this country will follow the reporting rule and auto-generate Transmission records as appropriate.
Custom Agency Report Formats
In addition to the formats mentioned above, you can generate an ICH E2B R2 or ICH E2B R3 file for global submissions.
Vault Safety also supports custom E2B formats using the E2B plus SDK tool. Contact your Veeva Managed Services representative for help generating custom E2B formats.
Custom Agency Gateways
For electronic AS2 communication with an agency, configure a Custom AS2 Gateway.
