1. Japan User's Guide
  2. Import ICSR Reports
  3. Incoming ICSR Reports
  4. Import E2B (R3) Messages

Import E2B (R3) Messages

  • The import process for PMDA E2B R3 imports a single XML file similar to that of a EMA R3 message (unlike PMDA E2B R2 which consists of two files I & J).
  • ICSR Import logic for PMDA E2B R3 enables you to import an incoming ICSR file using PMDA E2B R3 profile that consist of only ICH elements i.e. if there are only the ICH elements present in the incoming message, the files would still be imported for ICH elements.
  • In the incoming ICSR message for both PMDA E2B R2 and R3, if there is no J2.1a (for R3) and J.4a (for R2) value in the incoming ICSR message then it is considered as Marketed ADR report, and either domestic or foreign is decided based on the COI identified on the data in the incoming ICSR (Primary reporter country or the Reaction occur country).
  • Similar to that of PMDA E2B R3 export (same as ICH and EMA) the incoming PMDA E2B R3 messages is expected to be in UTF-8 format rather than the Shift-jis. In case of PMDA E2B R2 (in Oracle Argus Safety the encoding is governed based on the Reporting Destination configuration).
  • The following are the PMDA E2B R3 specific rules applied to validation logic during import of PMDA E2B R3 file:
    • During validations, the special internal logic of considering the Nullification report as Completion Report (J2.7.1-MHLWADMICSRCOMPLETECLASSR3="completed") is considered applicable for PMDA E2B R3. Additionally, the same logic is extended for the Downgrade report for the PMDA E2B R3 message.
    • The following is the Minimum case creation validation logic for Reaction for PMDA E2B R3 Research & measure (AE, AF, DE,DF, BC, BD, AG, or DG) category of report:

      If the incoming file does not comprise a Reaction than a Dummy relation is used during executing the minimum case validation.

      (For details on the profile switch, refer to Oracle Argus Safety Japan Administrator's Guide).

      (For details on minimum case validation, see section ICSR Import Framework in the Oracle Argus Interchange User's Guide.

    • The following is the COI Identification logic for Minimum case validation:

      If Reporting Category is AE, AF, DE, DF, BC, BD, AG, or DG, then fetch the value based on the availability in the following order:

      1. Fetch COI from the Primary Reporter C.2.r.5= 1.
      2. Fetch COI from E.i.9.
      3. Fetch the country from the First reporter which has valid C.2.r.3 value.
  • In the incoming PMDA E2B R3 message file the following date elements might contain the time zone component. In case these date elements contain the time zone offset, then adhere to that time zone offset in the element value while converting it in the GMT.
    • J2.2.1 - Date of Reporting
    • N.1.5 - Date of Batch Transmission
    • N.2.r.4 - Date of Message Creation
    • C.1.2 - Date of Creation
    • C.1.4 - Date Report Was First Received from Source
    • C.1.5 - Date of Most Recent Information for This Report

    Oracle Argus Safety supports time component for N.1.5, N.2.r.4, and C.1.2 only.

    In case C.1.4, C.1.5, and J2.2.1 values are in CCYYMMDD precision i.e. without the time component then consider the incoming value to be in GMT and store it without any transformation.

    Sample date formats:

    • 23-Jan-2017 08:30 +3.5

      EMA & PMDA: +3.5 for converting it to GMT: > If Oracle Argus Safety support's time, then save the converted date. > If Oracle Argus Safety does not support's time, then strip the time from converted date, and save.

    • 23-Jan-2017 08:30

      EMA & PMDA:

      > If Oracle Argus Safety support's time, then save the incoming date as-is. > If Oracle Argus Safety does not support's time, then strip the time from as-is date, and save.

    • 23-Jan-2017

      EMA & PMDA: Save the date as-is.

  • PMDA E2B R3 regulation have introduced as a new concept of Urgent Report (J2.3 (MHLWFLAGFORURGENTREPORT) = 1). The Urgent Report is treated as regular initial or a follow-up report as applicable.
  • The application logic for attachment import supports the compression algorithm as per the profile switch "Compression algorithm for file attachments in PMDA E2B R3".
  • Similar to that of EMA E2B R3, if the Reporting destination is configured to transmit the Attachments then the PMDA E2B R3 import logic imports all the valid attachments that are allowed to be added into the case form as configured in the profile switch "Case Processing > Valid Attachment File Types".

Parent topic: Incoming ICSR Reports