[co-author: Eftychia Sideri]

The European Medicines Agency (“EMA”) has launched a new and improved version of EudraVigilance. EudraVigilance is the system for managing and analysing information concerning suspected adverse reactions to medicinal products authorised or being studied in clinical trials in the European Economic Area (“EEA”).

EMA announced that the new and improved version of EudraVigilance would facilitate reports by market authorisation holders and sponsors of suspected adverse reactions. A better process for analysis of information to suspected adverse reactions is provided for the benefit of patient safety in the EEA.

According to the EMA, the new EudraVigilance system has several significant benefits including:

• Better detection of new or changing safety issues, enabling rapid action to protect public health;
• Better searchability and more efficient data analysis;
• Ability to support an increased number of individual case safety reports (“ICSRs”) needed due to the new requirement to report non-serious cases to EudraVigilance;
• Reduced duplication of efforts;
• Marketing authorisation holders no longer need to provide ICSRs to national competent authorities, they have to submit these to EudraVigilance only;
• Enhanced collaboration between EMA and World Health Organisation.

Accompanying the launch of the new Eurdravigilance system several legal obligations will apply to mandatory electronic reporting on Eudravigilance. The simplified electronic reporting of suspected adverse reactions related to medicinal products by national Competent Authorities and MAH to EudraVigilance will become mandatory six months after the launch of the new and improved Eudravigilance system i.e 22 May 2017.

According to the announcement of the EMA Management Board which has been published on May 2017, the legal obligations that will apply to mandatory electronic reporting through the new EudraVigilance system concern:

• Section 1 “Recording and reporting of suspected adverse reactions” of Chapter 3 “Recording, reporting and assessment of pharmacovigilance data” under Title IX “Pharmacovigilance” of Directive 2001/83/EC3, and
• Articles 24(4), 28(1), 28a(1)(c) and 28c(1) of Chapter 3 “Pharmacovigilance” under Title II “Authorisation and supervision of medicinal products for human use” of Regulation (EC) No 726/2004

EMA underlines that the reporting of adverse reactions by patients and healthcare professionals to national competent authorities based on local spontaneous reporting systems is not subject to change. Likewise, the current process for reporting of suspected unexpected serious adverse reactions during clinical trials will not change until the entry into application of the Clinical Trial Regulation.