5 Inclusion of reactions sent by PMDA to the MAH

As per the updated guidance, it is necessary to include the reactions reported to MHLW directly (PMDA/MHLW sends back such cases to the MAH).

In order to include such reactions sent by PMDA/MHLW to the MAH, follow the steps below:

1. Define a case classification in Codelist > Flexible Re-Categorization > CASE_CLASSIFICATION to define PMDA to MAH cases.
   For example, PMDA から送られた
2. When PMDA/MHLW sends a case to the MAH, create the case and add the case classification in the Case form > General tab > Classification (分類) window.
3. Select the classification defined in step a above in the configuration screen.
   The PSR/ReSD configuration screen has been enhanced to provide an option to configure the case classification using the list box Classification for cases sent by PMDA (PMDA によって送信された症例の分類).

   Note:

   If the option All cases irrespective of Case Classifications (症例の分類に関係なくすべての症例) is selected, then all the cases, irrespective of the case classification set in the case, are considered for inclusion in the report. Even cases where there is no case classification set are considered. Depending on the volume of cases, this may impact the performance of report generation. Hence, it is recommended to select case classification(s) in the PSR/ReSD configuration screen.