As per the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) standards, the pharmaceutical companies must submit the adverse event reports for their medicine and medicinal products to the concerned regulatory authority. The pharmaceutical companies exchange the adverse event (Safety report) information as Individual Case Safety report (ICSR) file in various formats (For example, paper base formats such as yellow cards, CIOMS forms, MedWATCH or through electronic media) between a company and trading partners such as regulatory authorities and business partners.
As the high volume of data and the large number of potential participants are involved in exchanging the safety reports, the ICH community has recommended the pharmaceutical companies to exchange the safety report information through electronic media using the ICH E2B and HL7 formats. The E2B and HL7 are the international standard format that allows the users to send and receive safety reports and Medical Device Reports (MDRs) as a structured data using XML or SGML.
agXchange Electronic Submission Module (agXchange ESM) allows the users to quickly, easily and securely transmit and receive the safety reports and MDRs electronically between the regulatory authorities and business partners. agXchange ESM facilitates transmission of safety reports in ICH E2B format using XML or SGML. ESM server uses the Electronic Data Interchange For Administration, Commerce and Transport (EDIFACT) and Electronic Standards for the Transfer of Regulatory Information (ESTRI) gateway for exchanging safety report information.
agXchange ESM supports electronic exchange of safety information as per ICH E2B (R2) and HL7 ICSR R3 standards. The Health Level 7 (HL7) ICSR Release 3 standards (HL7 ICSR R3) standard is a particular message based on the HL7 Version 3 messaging standard (HL7 V3), which provides a broader platform for health care information transfer. The guidance for transmitting ICSR information for HL7 includes provisions for transmitting all relevant data to assess an ICSR.
agXchange ESM also supports the electronic Medical Device Reporting (eMDR) as per HL7 R1 standards. The application provides capability to export the medical device adverse event reports electronically. ESM server uses the Electronic Submission Gateway (ESG) for exchanging MDRs electronically.
Using agXchange ESM, users can submit the safety reports and MDRs individually or submit multiple reports in a single transaction, and each report is assigned with a unique safety report ID. Before submission, each report is validated based on the validations defined for the receiver (For example, Eudravigilance data validations). After submission, the user can view both the Message Disposition Notification (MDN) and Acknowledgement received. In addition to the raw XML view, user can view the ICSR files in a user-friendly view (human-readable view) that enables the users to review the reports and acknowledgements. In agXchange ESM, you also can audit and archive every transaction.
agXchange ESM periodically checks for E2B Messages that are in queue in ESM Server and process them accordingly. These E2B messages can contain requests for exporting, importing ICSRs and MDRs, importing acknowledgements or can contain requests to archive or delete ICSRs.
Note: For successful electronic
transmission of ICSRs between pharmaceutical companies, regulatory authorities
and business partners, both the sending unit and receiving unit must have
similar structure data elements setup in place.
To transmit the adverse event report as ICSR file, the ICSR report must
contain Patient details, Reporter Information, Adverse Event information
and Product details.
Following diagram explains the electronic transmission of ICSR file between agXchange ESM and regulatory authority:
Electronic Transmission of ICSR File