License Configuration

The following table displays the Japanese specific fields on the License Configuration window:

Field	Description
PMDA Re-examination Date	The date of the next PMDA examination.
Clinical Compound Number	The number that identifies the specific chemical compound. You can edit this field when the Authorization Country is Japan and the license type is either Investigational Drug or Investigational Vaccine. The Clinical Compound field is only available to users to Oracle Argus Safety Japan.
TIKEN	Selecting the TIKEN check box indicates that the customer will not send the investigational report for the other license.
Blind J.10/J2.11 in PMDA AE Paper Report	This check box is disabled by default and shall be enabled only when the License country is Japan.
Medicinal Product Name	This field is to transmit the investigational products for the DC or DD reporting category in G.k.2.2. This configuration could be used in specific use cases as per the PMDA guidance if: The drug has multiple CCNs (Clinical Compound Numbers). It is used for different studies due to a different route of administration. The active ingredient is approved in JP. It is a foreign CT report.
PMDA Device Classification 1	This field PMDA Device Classification 1 is for configuring Device Classification printed in PMDA Device report.
PMDA Device Classification 2	This field PMDA Device Classification 2 is for configuring Device Classification printed in PMDA Device report.
PMDA Device Classification 3	This field PMDA Device Classification 3 is for configuring Device Classification printed in PMDA Device report.
Status Category of new drugs	This list captures the Status category of new drugs. The data in this list is populated based on the data in the License Category code list.
Risk Category of OTC drugs	This list captures the Risk Category of over-the-counter (OTC) drugs. The data in this list is populated based on the data in the Risk Category of OTC Drug code list. These new fields available in License Configuration print for both Print and Print All options. They also support the License/Product with Licenses copy functionality. Any changes to these fields value is logged for audit.

These fields are audit-logged.

These fields are covered by the back-end PL/SQL APIs for License Configuration data table updates and audit-logging.

The fields available in License Configuration print for both Print and Print All options. They also support the License/Product with Licenses copy functionality. Any changes to these fields value is logged for audit.

Note:

Other fields, such as Trade Name (J) or Comments (J), are for Japanese data entry equivalent to English fields.