Enable PMDA (Japan) Submission Rules

Learn how to update your Vault’s configuration to enable PMDA (Japan) Submission Rules support.

About the Feature

Support for PMDA (Japan) Submission Rules was added in 21R3. Vaults created in 22R1 or later include the necessary configuration by default, while Vaults originally deployed earlier than 22R1 must have the configuration upgrades described on this page to enable this feature.

Ensure your Vault has the following configuration to enable data entry of Japan local fields and generation of PMDA E2B(R3) files:

  1. Enable Localized Submissions and Translation Support
  2. Enable Local Fields for PMDA (Japan)
  3. Enable PMDA E2B(R3) Export

Assign the PMDA Rule Set to the PMDA Organization

  1. In Business Admin, navigate to Organizations > PMDA.
  2. Select Edit
  3. Select PMDA ICSR Reporting Rule Set in the Submission Rules field.
  4. Select Save.

PMDA Submission Rules Field

Create the Re-evaluate Reporting Obligations Action on the Localized Case Object

  1. In Business Admin, navigate to Configuration > Objects > Localized Case > Actions.
  2. Select Create.
  3. Select “Re-evaluate Reporting Obligations” from the dropdown menu.
  4. Select Continue.
  5. Select Save.

Add the Re-evaluate Reporting Obligations User Action to Localized Case Lifecycle States

You must add the Re-evaluate Reporting Obligations Action to the Localized Case lifecycle States:

  • Active
  • Revision
  • Translation Entry
  • Translation Review
  1. In Admin, go to Configuration > Object Lifecycles > Localized Case Lifecycle.
  2. Select a [State].
  3. Select Edit from the User Actions section.
  4. Select Create Rule.
  5. Select Re-evaluate Reporting Obligations from the Allow the following actions dropdown menu.
  6. Enter “Re-evaluate Reporting Obligations” in the Action Label section.
  7. Select Save.

Add the Re-evaluate Reporting Obligations Entry Action to the Approved State

  1. In Admin, go to Configuration > Object Lifecycles > Localized Case Lifecycle > Approved.
  2. Select Edit from the Entry Actions section.
  3. Select Create Rule.
  4. Select Re-evaluate Reporting Obligations from the Allow the following actions dropdown menu.
  5. Enter “Re-evaluate Reporting Obligations” in the Action Label section.
  6. Select Save.

Re-evaluate Reporting Obligations Action

(Optional) Configure the Due in Days is Mandatory Validation Rule

When you generate a PMDA downgrade report, Vault uses the “Due in Days” value from the previous submission record. If the previous submission record does not have a “Due in Days” value specified, the system will use the “15 days” value by default to calculate the downgrade report due date.

To prevent this, we recommended configuring a validation rule on the “Due in Days” field:

  1. In Business Admin, navigate to Configuration > Objects > Transmission > Validation Rules.
  2. Select Create.
  3. Complete the Create Validation Rule page with the following details:
    • Label: Due in Days is Mandatory
    • Error Message: “Due in Days is a mandatory field for PMDA.”
    • Error Location: Due in Days
    • Validation Expression: not (IsBlank(due_in_days_v) && transmission_document_typev = 'pmda_e2b_r3_v')
  4. Select Save.