EMA Green Lights New EudraVigilance System for Adverse Reactions, Pharmaceutical & Medical Device Update, Vol. IV, Issue III

Jones Day

On May 22, 2017, the European Medicines Agency ("EMA") announced the full functionality of the new EudraVigilance system for the collection and monitoring of suspected adverse reactions with medicinal products that are authorized or being studied in clinical trials in the European Economic Area ("EEA"). In accordance with Article 24(2), third subparagraph of Regulation (EC) No 726/2004 of the European Parliament, and of the Council of March 31, 2004, the EMA confirmed the EudraVigilance database is fully functional and meets necessary functional specifications after the consideration of an independent audit and subsequent favorable recommendation by the Pharmacovigilance Risk Assessment Committee.

The new and improved version of the EudraVigilance database will be launched on November 22, 2017. The system's enhanced functionalities for reporting and analyzing suspected adverse reactions aim to better support the safety monitoring of medicinal products and intend to allow a more efficient reporting process for stakeholders. More specifically, the EMA expects the new EudraVigilance database to bring the following benefits:

  • Marketing authorization holders will no longer be required to submit individual case safety reports ("ICSRs") to individual national competent authorities. They will submit such reports directly to EudraVigilance, resulting in a simplified reporting of ICSRs;
  • The centralized nature of the EudraVigilance database will enable better detection of new or changing safety issues, allowing rapid action to protect public health;
  • The broad access to reports of suspected adverse reactions by health care professionals and the general public via a public interface will increase transparency concerning suspected adverse reactions in the EEA;
  • The enhanced database will result in increased system capacity and performance to support the large volumes of users and reports; and
  • Since the EMA will make the reports of individual cases of suspected adverse reactions within the EEA available to the World Health Organization ("WHO") Uppsala Monitoring Centre directly from EudraVigilance, there will be more efficient collaboration with the WHO.

To prepare for the system's official launch, users—including national authorities, marketing authorization holders, and clinical trial sponsors—must adapt their processes and local IT infrastructures to ensure they are compatible with the new system. Marketing authorization holders must be ready to start submitting all suspected adverse reactions into the new EudraVigilance system six months after its launch (i.e., around May 2018).

The EMA announced it intends to support national authorities, marketing authorization holders, and clinical trial sponsors in the EEA through targeted e-learning and face-to-face training, webinars, and information days. In addition, users will be able to test the new functions of the EudraVigilance system and the internationally agreed format for ICSRs in a test environment available on June 26, 2017.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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