Logic update for G.k.2.2 and J2.11

Summary

Logic for G.k.2.2 and J2.11 as per the new PMDA E2B(R3) investigational reporting (34397868)

Description

PMDA published notifications for new investigational reporting. The mandatory date for submitting investigational reports as per the updated notification is 01-Sep-2022.

Mapping for MHLWADMICSRREPORTTIMESEVENT [J2.11] and MEDICINALPRODUCT [G.k.2.2] elements for PMDA E2B(R3) profile has been enhanced as below:

• MHLWADMICSRREPORTTIMESEVENT[J2.11]

  When the PMDA E2B(R3) report is generated with reporting category DA, DB, DC, or DD, Listedness is transmitted in J2.11 for each product-event combination.

• MEDICINALPRODUCT[G.k.2.2]
  When the PMDA E2B(R3) report is generated for a foreign case with investigational products, the mapping logic works as below:

  • If J2.1a = DC or DD,
    • If data is entered in Console > Medicinal Product Name, then transmit that value.
    • Or, transmit the same value as for the domestic marketed company product scenario.
  • If J2.1a <> DC or DD,
    • Transmit the same value as in the domestic marketed company product scenario.
  • If the drug codes do not exist in both above scenarios, then transmit the Clinical Compound Number. If the drug codes exists, transmit the English Product Name.

Ported from

8.2.3.2