Standard Agency ICSR Submissions

Learn about the standard agencies for which Vault supports submissions.

About Standard ICSR Submission Support

Vault supports ICSR submissions to standard agencies. This includes:

  • Providing reporting rules to evaluate Submissions
    • Studies and Case Products with an eligible Drug Role that have registrations in a country within an agency’s jurisdiction trigger reporting rules to evaluate submissions to that agency.
  • Assigning jurisdictions, though you can update assigned country jurisdictions to any agency based on your business process.
  • Providing compliant report formats
  • Supporting electronic communication
  • Configurable Transmission Profiles
  • Gateway response mapping

EMA

Set up ICSR submissions to the EMA using the following information:

  • Reporting rules: The EMA ICSR Reporting Rule Set
  • Jurisdictions:
    • 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)
  • Report format: EMA E2B(R3)
  • AS2 Connection: Configure the EMA AS2 Connection to communicate electronically with the EMA through EudraVigilance.
  • Transmission Profiles:
    • EVCTMPROD: For Submissions to the EudraVigilance Clinical Trial Module (EVCTM)
    • EVHUMAN: For Submissions to the EudraVigilance Post-Authorisation Module (EVPM)

EMA MDN and ACKs

Vault maps EMA gateway responses to Vault response labels (ACK 1–4) and Transmission lifecycle states:

Vault 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 Accepted
  • ACK Rejected
  • ACK Warning
ACK 4 n/a n/a

For help resolving EMA E2B(R3) issues, see Troubleshoot EMA Gateway Submissions.

FDA

Set up ICSR submissions to the FDA using the following information and links:

  • Reporting rules: The FDA ICSR Reporting Rule Set
  • Jurisdictions:
    • 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.)
  • Report formats:
  • AS2 Connection: Configure the FDA AS2 Connection to communicate FDA ESG endpoints for electronic communications with the FDA.
  • Transmission Profiles:
    • CBER: For ICSR Transmissions to the Center for Biologics Evaluation and Research (CBER) with the FDA AS2 Connection
    • CBER Study: For study data Transmissions to the Center for Biologics Evaluation and Research (CBER) with the FDA AS2 Connection. Requires activation.
    • CBER VAERS: For VAERS ICSR Transmissions to the Center for Biologics Evaluation and Research (CBER) with the FDA AS2 Connection
    • CDER: For ICSR Transmissions to the Center for Drug Evaluation and Research (CDER) with the FDA AS2 Connection
    • CDER IND Exempt: For study data Transmissions for marketed products that are exempt from Investigational New Drugs (IND) requirements. Requires activation.
    • CDER Study: For study data Transmissions to the Center for Drug Evaluation and Research (CDER) with the FDA AS2 Connection. Requires activation.
    • FDA Study: The FDA is entering a transition period and will be accepting both FDA MedWatch and FDA E2B(R3) formats. Follow your organization’s procedures for determining how to submit premarket cases to the FDA. Previously, this Transmission Profile was available to generate and manage manual Submissions for ICSRs in a clinical study using the FDA MedWatch 3500A form.
    • GWTEST: For test Transmissions with the FDA AS2 Connection

FDA MDN and ACKs

Vault maps FDA gateway responses to Vault response labels (ACK 1–4) and Transmission lifecycle states.

FDA FAERS

Vault Response Label Agency Response Type Vault Lifecycle States
ACK 1 MDN (Sync MDN) MDN Received
ACK 2 Final ACK
  • ACK Accepted
  • ACK Rejected
  • ACK Warning
ACK 3 n/a n/a
ACK 4 n/a n/a

For help resolving FDA E2B(R2) issues, see Troubleshoot FDA Gateway Submissions.

FDA VAERS

Vault 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
  • ACK Accepted
  • ACK Rejected
  • ACK Warning

Health Canada

Set up ICSR submissions to Health Canada using the following information and links:

  • Reporting rules:
    • Vault does not currently have a designated rule set for Health Canada. However, you can use the FDA ICSR Reporting Rule Set as a 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.
    • By default, back reporting is turned on for reports received from Health Canada.
  • Jurisdiction: Canada
  • Report format: Health Canada E2B(R2)
  • AS2 Connection:
    • Configure the Health Canada AS2 Connection to communicate electronically with the Canada Vigilance Program (CVP).
    • Because Health Canada does not allow testing with third-party vendors, their gateway has not been vendor-tested with Veeva Safety. You must perform additional testing when setting up Health Canada electronic submissions. Contact Veeva Managed Services for assistance.
  • Transmission Profiles:
    • HC MHPD: For submitting postmarket reports to Health Canada’s Marketed Health Products Directorate (MHPD)
    • HC TPD: For submitting clinical trial reports to the Health Canada’s Therapeutic Products Directorate (TPD)

MFDS

Set up ICSR submissions to the Republic of Korea’s Ministry of Food and Drug Safety (MFDS) using the following information and links:

MFDS MDN and ACKs

Vault maps MFDS gateway responses to Vault response labels (ACK 1–4) and Transmission lifecycle states:

Vault Response Label Agency Response Type Vault Lifecycle States
ACK 1 MDN (Async MDN) MDN Received
ACK 2 Final ACK
  • ACK Accepted
  • ACK Rejected
  • ACK Warning
ACK 3 n/a n/a
ACK 4 n/a n/a

MHRA

Set up ICSR submissions to the United Kingdom Medical and Healthcare products Regulatory Agency (UK MHRA) using the following information and links:

NMPA

Set up ICSR submissions to the National Medical Products Administration (NMPA) using the following information and links:

NMPA MDN and ACKs

Vault maps NMPA gateway responses to Vault response labels (ACK 1–4) and Transmission lifecycle states:

Vault Response Label Agency Response Type Vault Lifecycle States
ACK 1 MDN (Async MDN) MDN Received
ACK 2 Final ACK
  • ACK Accepted
  • ACK Rejected
  • ACK Warning
ACK 3 n/a n/a
ACK 4 n/a n/a

PMDA

Set up ICSR submissions to the Pharmaceuticals and Medical Devices Agency (PMDA) using the following information and links:

PMDA MDN and ACKs

Vault maps PMDA gateway responses to Vault response labels (ACK 1–4) and Transmission lifecycle states:

Vault Response Label Agency Response Type Vault Lifecycle States
ACK 1 MDN (Async MDN) MDN Received
ACK 2 Final ACK
  • ACK Accepted
  • ACK Rejected
  • ACK Warning
ACK 3 n/a n/a
ACK 4 n/a n/a

VigiFlow

Vault supports Submissions to VigiFlow. For information on configuring electronic communication, contact your VigiFlow representative.

  • Jurisdiction: Based on your business process, assign VigiFlow jurisdiction over applicable countries.
  • Report format: LATAM E2B(R3)
  • Transmission Profile: Based on your business process, set up Transmission Profiles for electronic submissions.

Other Agencies

Vault includes many inactive regulatory authority agencies. You can view these agencies by navigating to Business Admin > Objects > Organizations and filtering by the Agency organization type. You can activate agencies or add custom Agencies.

Set up ICSR submissions to other agencies using the following information and links:

  • Reporting rules: Use 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. Standard Reporting Rule Sets describes the standard reporting rule sets that you can assign agencies.
  • Jurisdiction: Assign agencies jurisdiction over countries for which ICSR reporting is required.
  • Report formats: In addition to the formats for the standard agencies described above, you can generate:
    • ICH E2B(R2) or ICH E2B(R3) file for global submissions
    • EU Convention E2B(R2) file with regional data elements for international submissions, for example, Swissmedic
    • Custom E2B formats using SDK to create the E2B+ file. This feature supports calling an optional external E2B builder if required. Contact your Veeva Representative for help generating custom E2B formats.
  • AS2 Connection: Configure a Custom AS2 Connection for electronic AS2 communication with an agency.
  • Transmission Profile: Set up the Transmission Profiles for agencies to which you want to transmit electronic submissions.

Back Reporting

Vault supports configurable back reporting for any reporting destination, including agencies and licensed partners. Depending on your Admin’s configuration, back reporting may be available only for certain reporting destinations.