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The European Medicines Agency (EMA) manages the EudraVigilance data processing network, allowing the electronic exchange of suspected adverse drug reaction reports between EMA, national competent authorities, marketing authorisation holders and sponsors of clinical trials in the European Economic Area.
The following organisations are partners in the EudraVigilance electronic data interchange process:
Category I: Regulators
National competent authorities in the European Economic Area (EEA) including regional pharmacovigilance centres, where applicable.
Category II: Pharmaceutical industry and commercial sponsors
Marketing authorisation holder (company):
A pharmaceutical company holding a valid marketing authorisation for a medicinal product in the EEA, independent of the authorisation procedure of this medicinal product.
Applicant (AP):
An applicant is a pharmaceutical company applying for a marketing authorisation in the EEA.
Sponsor (SP):
A sponsor is an individual, company, institution or organisation taking responsibility for the initiation, management and/or financing of a clinical trial. From the registration perspective there are two categories of sponsors:
- Commercial sponsors (CS) and
- Non-commercial sponsors (NCS)
Category III: Non-commercial sponsors (NCS)
A non-commercial trial is defined as a trial conducted by a non-commercial organisation with no industry sponsor that is not part of the development programme for a marketing authorisation of a medicinal product or, if potentially leading to a marketing application, where the holder of the intellectual property/patent is a not-for profitable organisation.
A trial may qualify as being classified non-commercial if funding is provided in the form of an educational, unrestricted grant for the administrative support and does not exceed 10% of the cost of the trial, or where the drug is provided free by a company.
Clinical research organisations (CROs) which don't qualify as sponsors, marketing authorisation holders or applicants as well as IT vendors can't become a registered organisation in the EV community. However, CROs and IT vendors may be registered by an company, applicant, commercial or non-commercial sponsor as 'third party service providers' acting on behalf of these organisations by providing services related to EV.