One of the milestones during 2022 in the EudraVigilance database was the mandatory use of the ISO Individual Case Safety Report (ICSR) standard (ISO 27953-2:2011) based on the ICH E2B(R3) modalities and the ISO terminology on pharmaceutical dose forms and routes of administration, (ISO 11239:2012).

Following this important milestone, this information day will describe and highlight other aspects for further development in the database and initiatives driven by international activities, together with the management and maintenance of EudraVigilance for the good functioning of the EU pharmacovigilance network.

Regulation (EU) 2016/679, the General Data Protection Regulation (GDPR) applies since 25 May 2018. MAHs are controllers for the personal data processing activities carried out pursuant to the pharmacovigilance legislation including the access and further processing of ICSR data originating from EudraVigilance. The data protection activities, measures and responsibilities will be described and developed during this information day.

The European Medicines Agency (EMA) is implementing the ISO IDMP standards for the identification of medicinal products in a phased programme, based on the four domains of master data in pharmaceutical regulatory processes: substance, product, organisation and referential (SPOR) data. An update of the SPOR activities will be highlighted.

According to Article 24 (3) of Regulation 726/2004, the Agency shall, in collaboration either with the MAHs or with the Member State that submitted an individual suspected adverse reaction report to the EudraVigilance database, be responsible for operating procedures that ensure the quality and integrity of the information collected. Moreover, specific quality system procedures and processes shall be in place to ensure submission of accurate and verifiable data on serious and non-serious suspected adverse reactions to the EudraVigilance database within the 15 or 90-day time frame [IR- Art 11 (1) (c)]. To support these legislative requirements, the Agency is working on the process to implement compliance reports for electronic submission of ICSRs. These reports and their implementation will be fully described during this information day.

An update of the existing ICH E2D (Post Approval Safety Data Management: Definitions and Standard for Expedited Reporting) guideline is proposed to clarify the management of post-approval safety information from new or increasingly used data sources. An update of the revision of the E2D guideline will be also discussed.

Other aspects such as the role of the EU QPPVs, quality control of ICSRs, pharmacovigilance inspections findings and examples of the use of artificial intelligence will be described.