|E-Reporting to Member States
Mandatory e-reporting essentials
EudraVigilance is a data processing network and management
system for reporting and evaluating suspected adverse drug reactions (ADRs) during
the development, and following the marketing authorisation of medicinal
products in the European Economic Area (EEA). The first operating
version was launched in December 2001.
- The electronic exchange of suspected adverse
drug reaction reports known as Individual Case Safety Reports)
between the European
Medicines Agency (EMA), National Competent Authorities (NCAs), Marketing
Authorisation Holders (MAHs), and sponsors of clinical trials in the EEA.
- Early detection of possible safety signals associated with medicinal
products for human use.
- Continual monitoring and evaluation of potential safety issues in
relation to reported adverse reactions.
- Decision making process, based on a broader knowledge of the adverse
reaction profile of medicinal products especially in the form of
Taking into account the pharmacovigilance activities
in the pre- and post- authorisation phase, EudraVigilance provides
two reporting modules:
- The EudraVigilance Clinical Trial
Module (EVCTM) to facilitate the electronic reporting
of Suspected Unexpected Serious Adverse
Reactions (SUSARs) as required by Directive 2001/20/EC
- The EudraVigilance Post-Authorisation Module
(EVPM) for post-authorisation Individual Case Safety Reports (ICSRs) as required by Regulation (EC) No 726/2004, Directive 2001/83/EC as amended.
EudraVigilance is also one of the main pillars of the European
Risk Management Strategy, a joint effort
between the EMA and NCAs to strengthen
the conduct of pharmacovigilance in the EEA. EudraVigilance facilitates
the process of risk management at several levels including aspects
of risk detection, risk assessment, risk minimisation and risk communication.
Consequently, EudraVigilance contributes to the protection and promotion
of public health in the EEA, and provides a powerful tool for the
EMA and NCAs in monitoring the safety
of medicinal products and in minimising potential risks related to
suspected adverse reactions.
The reporting obligations of the various stakeholders are defined
in the Community legislation, in particular Regulation (EC) No 726/2004, Directive 2001/83/EC as amended and Directive 2001/20/EC.
Please consult the relevant sections on this website for further
Last update: Tuesday, 12 August 2014.
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