Draft report generation for PMDA Paper reports
For PMDA Paper reports, if the "Destination" is selected as Agency with PMDA E2B(R2) or (R3) profile, the application check the selected Report Form, and the product is populated in the Product drop-down based on the first occurring of the PMDA tab > License record, where the corresponding Reporting Category is set applicable for the selected Report Form.
If the Reporting Category is not set in the Analysis > PMDA tab for any of the license records, then the PMDA Report Form (PMDA報告様式) option is displayed in the Report Form drop-down for the PMDA paper report. When you select this option, the product is populated based on the left most suspect product having a drug license. On report generation, a message is displayed as Report cannot be generated because no reporting category is specified for the case. Please specify a reporting category on PMDA General tab. (報告分類が特定されていないため、報告を作成できません。PMDA情報の一般タブで報告分類を指定してください。)
Parent topic: PMDA E2B reports