Pharmacovigilance in 2024: how the European landscape is changing

European pharmacovigilance has gone through a period of profound change over the past year, driven by new regulations and innovative technologies. Issues such as the evolution of the XEVMPD, the introduction of the Product Management Service (PMS) and the application of Artificial Intelligence (AI), are transforming drug safety monitoring processes and data management. Calin Lungu, CEO of DDCS S.A., spoke about this during the European Pharmacovigilance Congress, the event dedicated to pharmacovigilance held in Milan in November 2024. Here are the topics addressed.

The revision of GVP XVI came into force in August 2024, introducing updated guidelines for risk minimization. One of the main innovations introduced was Addendum II, which provides detailed guidance on how to assess the effectiveness of risk minimization measures through structured data sources and advanced search methods.

Over the past few months, EudraVigilance, the European system for collecting and analyzing reports of suspected adverse reactions, has undergone significant improvements to optimize its efficiency and reliability. Among the main innovations are new business rules that make the management of Individual Case Safety Reports (ICSR) clearer and more structured, reducing errors in data transmission. In addition, technical updates have been implemented to improve the stability of the system, reduce disconnections and speed up response times, thus offering users a smoother and more reliable experience.

The management of access to the EMA system has also been revised. New multi-factor authentication options and more specific user roles have been introduced. These updates, which also include the possibility to upload documentation directly when requesting a role, reflect a commitment to security and operational convenience.

The update of the XEVMPD system marks the start of the transition to the new Product Management Service (PMS). The EMA has provided detailed guidance on how to verify and improve data quality, with a particular focus on pack sizes. This step requires a high level of precision to ensure a smooth migration.

The Product Management Service, which will replace XEVMPD, is an advanced platform for managing data on authorised medicinal products. In addition to improving data transparency and integrity, the system supports key applications such as ePI, Regulatory Procedure Management and the European Shortages Monitoring Platform (ESMP), demonstrating its central role in future regulation.

The integration of Artificial Intelligence (AI) in pharmacovigilance has been one of the most debated topics in recent months. With the publication of the “Guiding Principles for the Use of Large Language Models”, the EMA has set a clear path for the ethical and safe use of these technologies. AI promises to revolutionise data analysis, improving the ability to detect safety signals and optimising management processes.