R3Extend offers a system agnostic solution which can be integrated with Argus, ARISg or other safety systems to meet the compliance requirements of the China NMPA and FDA combination product.
R3Extend is your solution to manage the new ICH E2B(R3) regulation to meet the compliance requirements for China’s NMPA (formerly CFDA).
- A system agnostic solution which can be integrated with Argus/ARISg or other safety systems
- Can be easily plugged into your existing Adverse Event Reporting System to translate and transform E2B(R3) XML files into NMPA compliant reports
- Provides auto translation of key fields expected by NMPA from English to Chinese
- The China-R3 solution can be implemented on-premise or utilized in a SAS model
FDA Combination Product:
- Supports the reporting to FDA for drug/device, biologic/device, drug/biologic, or drug/device/biologic
- Compliant with Argus 8.x version
- In conjunction with business processes updates, the solution utilizes inherent Argus functionalities of E2B reporting along with User Defined Fields (UDF) and E2B Extension
- Translations and other user actions are fully audit logged