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Regulatory News | 04 October 2017 | By Michael Mezher
With the 22 November launch date for its revamped EudraVigilance system rapidly approaching, the European Medicines Agency (EMA) on Wednesday provided some last minute updates on what to expect during the transition to the new system.
The new system, developed in response to changes brought on by the EU's pharmacovigilance legislation that went into effect in 2012, promises to improve adverse event reporting and safety monitoring.
Specifically, the new system will allow drugmakers to report suspected adverse events directly to EudraVigilance rather than to national authorities and offers greater transparency and access to suspected adverse event reports to the public.
The new system will also allow for more efficient collaboration with the World Health Organization (WHO) by providing direct access to WHO's Uppsala Monitoring Centre (WHO-UMC).
Ahead of the new system's launch, EMA has provided updates to its EudraVigilance Go-Live Plan and issued a new note detailing the technical implications of the transition on adverse event reporting.
EMA says to expect a "cutover" period of two weeks when some key EudraVigilance functionalities will be partially or completely unavailable from 8-21 November to accommodate the transfer of some 11 million individual case safety reports (ICSRs) to the new system.
During the downtime, EMA says electronic submissions of data on medicines will be unavailable and electronic reporting of ICSRs by drugmakers and national authorities will be disrupted.
Instead, EMA says that marketing authorization holders (MAHs) and national authorities are expected to follow one of three options for reporting ICSRs and suspected unexpected serious adverse reactions (SUSARs) during the cutover time, depending on the national authority involved with the reporting.
For instance, MAHs reporting to the UK's Medicines and Healthcare products Regulatory Agency (MHRA) must follow option 3, while those reporting to France's Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM) must follow option 1.
Under option 1, MAHs and NCAs stop submitting ICSRs during the cutover and report them electronically in accordance with the new simplified reporting rules after 22 November.
Option 2 follows the same instructions as option 1, but requires MAHs to follow one of three alternative reporting arrangements with national authorities.
For option 3, MAHs continue to submit ICSRs electronically to national authorities "where this is technically feasible" and national authorities continue providing ICSRs to WHO-UMC. When electronic reporting is not feasible, MAHs must submit the reports electronically after the cutover period and continue to follow dedicated national reporting arrangements.
EMA, EudraVigilance Go-Live Plan, Technical Note
Tags: EudraVigilance, Pharmacovigilance, ICSRs, SUSARs, Adverse Event Reporting