Eudravigilance Concept & Functions

EudraVigilance (European Union Drug Regulating Authorities Pharmacovigilance) is a network for clinical data processing in the European Economic Area (EEA) and a system for assessment and reporting of Suspected Adverse Events (SARs) related to new drug entities during clinical development and marketed products across their life cycle.

The accessible impact of Eudravigilance on various stakeholders such as IT system developers; information management and data managers; Qualified Persons Responsible for Pharmacovigilance (QPPVs); sponsors of clinical trials; safety database, signal management and other individuals involved in pharmacovigilance has been internationally recognised.

Concept of Eudravigilance

In detection and analysis of risks associated with medicines, the analysis of safety data from spontaneous reporting systems has proven valuable for their use in medical practice and release into the market. Eudravigilance is the management of pharmacovigilance database authorised by European Economic Area (EEA) for collection and analysis of suspected adverse reactions in medicines. Eudravigilance governed by the Eudravigilance access policy was first operated in December 2001 to access the database, even for scientific publications. Based on research topics, type of publication and drugs involved, the Eudravigilance data can be used to publish safety issues, analyse methodologies in pharmacovigilance activities, support clinical perspective and also useful to European Union regulatory network. In 2010, pharmacovigilance legislation further enhanced and revised major policies in the new individual case safety report standards developed to account for the International Council for Harmonization of Technical Requirements available to the International Organization of Standardization and Pharmaceuticals for Human Use.

European Medicines Agency (EMA) and European Commission have agreed to streamline the monitoring of Eudravigilance through transitional arrangements by marketing authorisation holders. European Economic Area (EEA) marketing authorisation holders have initiated significant changes by electronic reporting and increasing access to suspected adverse reactions of medicines. The European Medicines Agency is responsible for the development, coordination and maintenance ofEudravigilance. The Eudravigilance Report system was designed for submitting and reporting suspected side effects inpre and post authorisationphases. The system detects signals of suspected side effects along with managing and analysing this information authorised by EEA to be used inclinical studies or trials. On behalf of the European Union medicines regulatory network, the EMA operates the system.

Functions of Eudravigilance

The full functionalities of Eudravigilance include extensive web access towards identifying possibilities and purposes related to health research using suspected adverse drug reactions data and dataset for academic research institutions. The main objectives include describing the access to the database for new research opportunities along with promoting appropriate use of data to support the effective and safe use of medicines. Eudravigilanceensures early evaluation or detection ofsafety signals and betterproduct informationfor medicines authorised in the EEA; effective and safe use of medicines by facilitating electronic exchange ofindividual case safety reports(ICSRs) between marketing authorisation holders(MAHs), national competent authorities (NCAs),EMA and sponsors ofclinical trialsin the EEA. Thiselectronic reportingis obligatory for sponsors ofclinical trials and marketing authorisation holders. TheEudravigilance system has a largepharmacovigilancedatabase that uses XML-based fully automated messaging and safety message processing mechanism with query and tracking functions.

Eudravigilance Clinical Trials module accounts suspected and unexpected serious adverse reactions (SUSARs) reported by sponsors ofinterventionalclinical trials; Eudravigilance Post-authorisation module reports suspected non-serious and serious side effects by healthcare professionals and patients, post-authorisation or non-interventional studies and worldwide spontaneous or non-interventional scientific literature. Eudravigilance data is analysed on a regular basis for information on authorised medicines at two or four week frequency.ThePharmacovigilance Risk Assessment Committee (PRAC)may recommend regulatory action on evaluating signals from Eudravigilance system.Eudravigilance is used by professionals and officers of medicines regulatory authorities and pharmaceutical companies having marketing authorisations in the EEA.