Update on EudraVigilance and on MHRA ICSR Submission Portal

ABSTRACT

EudraVigilance, as a system for managing and analysing information on suspected adverse reactions to medicines which have been authorized or being studied in clinical trials in the European Economic Area, is always improving and changing to comply with the latest trends as well as applicable regulatory guidelines. In recent years, the system faced multiple challenges continuous implementation of E2B(R3) standards for reporting;introduction of EVDAS access for Marketing Authorization Holders and of course the COVID-19 pandemic, which resulted in an enormous surge in reports coming into the system, as well as increased demand of public access to data via the ADR reports portal. Since the access to EVDAS has been granted to MAHs, there was a limit of five users per organization. Due to the stabilization of the system, this has now been increased to 10. Another new rule is the implementation of European Directorate for the Quality of Medicines & HealthCare (EDQM) codes for pharmaceutical dose forms and route of administration while reporting ICSRs. This poses a certain challenge for organizations, as they need to download and implement the terms onto their databases on a periodic basis. Changes to Article 57 Database (XEVMPD), another component of EudraVigilance, are also worth mentioning. While the information about medicinal products is preparing for transition to ISO IDMP standards, MAHs and Sponsors still have the obligation to send information about authorized and development medicinal products to XEVMPD. The platform runs on an older version of the Internet Explorer browser, which Microsoft stopped providing support for in June 2022. The European Medicines Agency provided a workaround using Microsoft Edge or by downloading extensions for other browsers that emulate the Internet Explorer mode. Not only EudraVigilance is being updated and modernized, internal EMA tools such as Service Desk are also keeping up with the pace and are being transferred from their current JIRA platform to ServiceNow (SNOW). We also cannot forget the changes post Brexit. MAHs are using the ICSR Submission Portal for transmission of ICSRs to MHRA, and since the beginning of October 2022, SUSARs from Clinical Trials are also submitted via this portal.