# PMDA Overview and Profile Setup

Safety supports a variety of case processing scenarios for Japan through _Domestic Case_ and _Localized Case_ workflows, and reporting to the PMDA. While many Safety capabilities apply to all _Cases_, including Japan and non-Japan _Cases_, this page outlines regionally specific features, such as the following:

* Support for <a href="/en/gr/696910/#cpr-section">Product and Substance registrations</a> 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 <a href="/en/gr/696910/#registration-type">Registration Type</a>, <a href="/en/gr/01163/">Japan Drug Dictionary codes</a>, and <a href="/en/gr/696910/#ccn">Clinical Compound Numbers</a>
* <a href="/en/gr/01137/">Translation features</a> for capturing information in English and Japanese
* Validation against ICH and PMDA <a href="/en/gr/01252/#pmda-icsr-reporting-rule-set">reporting rules</a>
* Support for <a href="/en/gr/696904/">Safety Measure Reports</a>
* Support for foreign clinical trial reporting, such as <a href="/en/gr/696910/#tiken">TIKEN scenarios</a> and <a href="/en/gr/696910/#inv-reg-gen-rpt">single or multiple Clinical Compound Number</a> reporting in the <a href="/en/gr/700008/#j-section">J2.12 and J2.13 data elements</a> of PMDA E2B(R3) reports
* Support for <a href="/en/gr/735519/">importing PMDA E2B(R3) files to _Inbox Items_ for creating Japan Domestic Cases</a>

## 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 <a href="/en/gr/01463/#pmda">review and enable PMDA-related features</a>.
* To capture data in fields required by the PMDA, your Admin must <a href="/en/gr/01194/#pmda">set up the Localized Business Admin library for Japan</a>.

## 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 <a href="/en/gr/7239/"> **User Profile**</a>.

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 <a href="/en/gr/01329/#enable-vault-system-settings">_Enable auto-set Inbox Item Localization by Reporter Country_ setting</a>, 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.

For more information, see <a href="/en/gr/696910/">Complete Intake and Process Cases for the PMDA</a>.