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Pharmacovigilance

European Medicines Agency new adverse drug reactions system to go live in November

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The EMA’s Pharmacovigilance Risk Assessment Committee has audited the new EudraVigilance information system for tracking suspected adverse reactions to authorised drugs and medicines being studied in clinical trials across the European Economic Area.

The European Medicines Agency (EMA) has announced that its new and improved version of EudraVigilance, the European information system of suspected adverse reactions to medicines, is on track to go live on 22 November 2017.

The EMA’s Pharmacovigilance Risk Assessment Committee has completed an audit and evaluation of the new EudraVigilance information system for tracking suspected adverse reactions to authorised drugs and medicines being studied in clinical trials across the European Economic Area (EEA). The new system will feature enhanced functionalities for reporting and analysing adverse events.

Specifically, the new system will enable simplified reporting of individual case safety reports. Marketing authorisation holders will no longer have to provide reports to national competent authorities, but directly to EudraVigilance, which will re-route the case safety reports to member states, reducing duplicated efforts. This centralised collection should allow better detection of new and changing safety issues, enabling more rapid action to protect public health where necessary. The public portal of the EudraVigilance database, adrreports.eu, will increase transparency by providing health professionals and the public with broader access to reports of suspected adverse reactions.

The updated system will have increased system capacity and performance to support large volumes of users and reports (including non-serious adverse reactions originating from the EEA), plus an enhanced search facility and more efficient data analysis capabilities.

The EMA will make the reports of individual cases of suspected adverse reactions within the EEA available to the WHO Uppsala Monitoring Centre directly from EudraVigilance, which means that member states will no longer need to carry out this task.

Patients and healthcare professionals will continue to report adverse reactions to national competent authorities and there will be no immediate changes to the reporting of suspected unexpected serious adverse reactions during clinical trials.

The new system will be available through a test environment from 26 June 2017 to allow users to become familiar with it. The EMA will also provide training to national competent authorities, marketing authorisation holders and sponsors of clinical trials in the EEA through targeted e-learning and face-to-face training sessions, webinars and information days.

Sunayana Shah, head of regulatory and safety policy at the Association of the British Pharmaceutical Industry, said: “This is the latest in a series of planned changes to the European pharmacovigilance system following the 2012 amendments to the European pharmacovigilance regulations and we anticipate that there will be significant simplifications of the operational tasks and availability of safety data to marketing authorisation holders.

“Authorisation holders will have to report adverse event reports to a single agency rather than the current multiple reporting obligations; there will be an enhanced resource for safety monitoring; and it is envisaged that there will be benefits to patients — in the form of the potential for earlier identification of changes to the benefit–risk assessment for medicinal products.”

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2017.20202860

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