Safety supports a variety of drug, device, and regenerative medicine case processing scenarios for Japan through domestic Case and Localized Case workflows. While many Safety capabilities apply to all Cases, there are regionally specific features, including:
- Product and Substance registrations for investigational and postmarketing products, ensuring compliant PMDA reporting for cases that originate within and outside of Japan
- Regionally required information such as Registration Type, Japan Drug Dictionary codes, and Clinical Compound Numbers
- Translation features for capturing information in English and Japanese
- Validation against ICH and PMDA reporting rules
- Safety Measure Reports
- Foreign clinical trial reporting, such as TIKEN scenarios and single or multiple Clinical Compound Number reporting in the J2.12 and J2.13 data elements of PMDA E2B(R3) reports
- Importing PMDA E2B(R3) files to Inbox Items for creating Japan domestic Cases
In addition, you can update your user profile to support more efficient local case processing.
Prerequisites
Consider the following requirements for processing cases reportable to the PMDA:
- To take full advantage of the Japan and PMDA functionality in Safety, your Admin must review and enable PMDA-related features.
- To capture data in fields required by the PMDA, your Admin must set up the Localized Business Admin library for Japan.