PMDA Overview and Profile Setup

Learn about Vault Safety features that support processing cases for Japan and reporting to the PMDA.

About Processing Cases and Reporting to the PMDA

Vault Safety supports a variety of case processing scenarios for Japan through Domestic Case and Localized Case workflows. While many Vault Safety capabilities apply to all Cases, including Japan and non-Japan Cases, this page outlines regionally specific features, such as the following:

Support for Product and Substance registrations for Investigational and Postmarketing products, ensuring compliant PMDA reporting for Cases that originate within and outside of Japan
Support for regionally required information such as Registration Type, Japan Drug Dictionary codes, and Clinical Compound Numbers
Translation features for capturing information in English and Japanese
Validation against ICH and PMDA reporting rules
Support for Safety Measure Reports
Support for foreign clinical trial reporting, such as TIKEN scenarios and single or multiple Clinical Compound Number reporting in the J2.12 and J2.13 data elements of PMDA E2B(R3) reports
Support for importing PMDA E2B(R3) files to Inbox Items for creating Japan Domestic Cases

Prerequisites

Consider the following requirements for processing Cases reportable to the PMDA:

To take full advantage of the Japan and PMDA functionality in Vault Safety, your Admin must review and enable PMDA-related features.
To capture data in fields required by the PMDA, your Admin must set up the Localized Business Admin library for Japan.

Profile Setup for Japan Case Processing

Though not a requirement for processing Cases for Japan, you can update your Profile to display menu, tab, field names, and picklist values in Japanese.

To edit the settings, select your Profile picture in the top-right corner of your Vault, and then select User Profile.

The following table highlights the local language processing options available in your User Profile settings:

Field	Description
Language	Select the language and locale for menus, tabs, field names, and picklist values.
Locale	The locale or country is automatically populated based on your selection in the Language field. This setting controls the display of dates and numbers. For example, dates in Japanese (Japan) appear in year/month/day format.
Default Localization	Select the default language and locale for system-provided and managed picklists and object lookup fields. This sets how localized values for Inbox Items and Cases are displayed in Object Reference fields.
Landing Tab	You can select the default tab Vault Safety displays when you log in. For example, selecting Localized Cases may be useful for Case Translators, who work primarily on the Localized Cases tab.

Automate Localization Setup

If your Admin has configured the Auto-select Inbox Item Localization by Reporter Country setting, Vault attempts to set the Inbox Item Localization using both the Primary Reporter Country and Report Type using the following logic:

If a match for the Primary Reporter Country and Report Type is found, the value appears in the Inbox Item Localization field.
If multiple matches for either the Primary Reporter Country or Report Type are found, Vault references the Inbox Item Reporter Language field.
- If there is no Reporter Language, Vault checks for an English record.
- If there are still multiple matches, Vault applies the first Localization record for that Country or Report Type.
If no matches are found for the Primary Reporter Country and Report Type, Vault leaves the Inbox Item Localization field blank.