PMDA E2B R3 ACK

• PMDA E2B R3 Acknowledgment Template profile "ICH-ICSR V3.0 ACKNOWLEDGMENT TEMPLATE - PMDA" is available in the application.
• Similar to EMA R3, PMDA E2B R3 supports Batch Acknowledgement transmission. The acknowledgements pertaining to ICSR received in the batch are sent only after processing all the ICSRs present in the XML file.
• The application supports the generation of the low level ACK for the PMDA E2B(R3) ICSR message imported in Oracle Argus Safety using physical media option at Agency level.
• The application generates PMDA E2B(R3) ACK as an XML file with the following file name format (unlike PMDA E2B R2 where it was a SGML):

  A-<Company's Abbreviation>-<Date of Reporting>-<unique number>.xml

  Attribute	Description
  Company's Abbreviation	Code List > Reporting Destination > EDI Tab > Company Identifier
  Date of Reporting	System date in Japan Time zone (using profile switch JPN_OFFSET) "YYYYMMDDHHMIss" format.
  Unique number	This unique number must be alpha-numeric value constructed by concatenating the Case Number and last 2 characters of SAFETYREPORTID tag value (i.e. AA, AB, and AC etc.). For example if the case number is "15JP000236" and Safety Report ID is "JP-SENDER-JAPAN-15JP000236AA" then the Unique number will be "15JP000236AA". In case of a batch ACK, use the case number form the first case of the batch.