1. China NMPA E2B(R3) Best Practices
  2. Observations during NMPA testing

12 Observations during NMPA testing

Oracle tested the post-marketed ICSRs generated using the NMPA out-of-the-box profile in Argus 8.2.3.1.

This testing was performed by submitting the XMLs to the NMPA test gateway and by receiving ACKs from NMPA.

Note:

NMPA does not allow software vendors to create test accounts, so Oracle was helped by Argus customers to perform it.

The below observations were made during the NMPA testing:

  1. NMPA has a hard validation to check if RECEIVEDATER3 [C.1.4] and RECEIPTDATER3 [C.1.5] are transmitted with the same value for the initial reporting. If the values are different for the initial reporting, then a negative ACK is received. It may be a valid scenario to have these dates different when the initial information is received and it is not reportable, and then when the follow-up information is received at a different date and it becomes reportable.

    Argus customers discussed with NMPA to clarify if they remove this validation, but at this moment, NMPA does not plan to remove it.

    Note:

    RECEIVEDATER3 [C.1.4] and RECEIPTDATER3 [C.1.5] should be transmitted with the same value for the initial reporting.
  2. NMPA has a hard validation to check if REACTIONSTARTDATER3 [E.i.4] is later than RECEIVEDATER3 [C.1.4]. ICSR is rejected when E.i.4 has date/time components and the date is the same in both elements. ICSR is accepted when E.i.4 has only a date component and the date is the same in both elements.

    Note:

    RECEIVEDATER3 [C.1.4] and RECEIPTDATER3 [C.1.5] should be transmitted with the same value for the initial reporting.
  3. The NMPA Implementation Guide states that DRUGAUTHORIZATIONHOLDER [G.k.3.3] should be provided in Chinese. During testing, it was observed that DRUGAUTHORIZATIONHOLDER [G.k.3.3] should be the name of the company registered with NMPA. It could have English, Chinese or mixed characters. NMPA accepts as a log the registered company name as it is.

    Note:

    The company name should be carefully registered with NMPA in the Console > Code Lists drop-down menu > Flexible Data Re-categorization option > Flexible Re-Categorization folder > MANUFACTURER Code List Name > cn attribute.
  4. NMPA has a hard validation to check if COMPANYNUMB [C.1.8.1] is the same as any previously submitted XML, but with different SAFETYREPORTID [C.1.1]. In this scenario, ICSR is rejected. The same case can be submitted from multiple companies with the same C.1.8.1 and with different C.1.1. However, within a company, C.1.1 should be the same.

    Note:

    Ensure that the E2B company number is deleted from the Case references section while copying a case in Argus that has submitted the E2B report. Thus, you avoid sending the same COMPANYNUMB [C.1.8.1] as any previously submitted XML, but with different SAFETYREPORTID [C.1.1].