Regulatory Compliance

The enhanced EudraVigilance system was launched on 22 November 2017.

  • Together with the launch, further legal obligations will became applicable and mandatory, for example:

    • Updated signal detection process
    • Marketing Authorisation Holders should monitor EudraVigilance data (via EVDAS, EudraVigilance Data Analysis System) for safety signals.
    • New reporting reportinng requirements
    • Safety signals should be reported to EMA and national competent authorities.
    • New SOPs
    • Serious and non-serious cases of suspected adverse drug reactions that occur in the EEA must be reported to EudraVigilance.
    • International data standards, including ISO / ICH E2B (R3) data structure for individual case safety reports (ICSRs) with new and different data fields are now mandatory.

CSO Pharma would be glad to support you any time as competent and reliable partner to comply new the new PV requirements.


Do you have a question - please feel free to contact us.
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