Can the OOTB Argus E2B(R3) NMPA profile be used to submit post-marketed and clinical trial ICSRs to NMPA?
No, the OOTB Argus E2B(R3) NMPA profile is developed based on the Implementation Guide published by NMPA, which includes 19 regional elements in the E2B(R3) report. Although the Implementation Guide is applicable for both post-marketed and clinical trial ICSRs, the NMPA has not published the mandatory date for submitting the SUSAR ICSRs in E2B(R3) format along with the regional elements (as of November 2021). For post-marketed ICSRs, use the OOTB Argus E2B(R3) NMPA profile.
For clinical trial ICSRs, use the ICH R3 profile configured to transmit narratives and reported terms in Chinese language. For more information about the steps, refer to the article 2393471.1 on My Oracle Support. Once NMPA announces the effective date for submitting the clinical trial ICSRs, including the 19 regional elements, then the OOTB Argus E2B(R3) NMPA profile is used.
Parent topic: Frequently asked questions