Pharmacovigilance

On 22 November 2017, EMA launched a new and improved version of EudraVigilance (human). The new system has enhanced features for the reporting and analysis of suspected adverse reactions, to support stronger safety monitoring of medicines and a more efficient reporting process for stakeholders.

After 22 November 2017, MAHs are no longer receiving ICSRs directly from NCAs. For MAHs to receive ICSRs concerning their medicinal products, the ICSR download functionality should be used.

Serious ICSRs

The marketing authorisation holder shall submit all serious ICSRs that occur within or outside the EU, including those received from competent authorities outside the EU, to the EudraVigilance database only.

serious valid ICSRs shall be submitted by the marketing authorisation holder within 15 days from the date of receipt of the reports;

Non-Serious ICSRs

The marketing authorisation holder shall submit all non-serious ICSRs that occur in the EU to the EudraVigilance database only.

non-serious valid ICSRs shall be submitted by the marketing authorisation holder within 90 days from the date of receipt of the reports.

All information can be found in Guideline on good pharmacovigilance practices (GVP) - Module VI – Collection, management and submission of reports of suspected adverse reactions to medicinal products (Rev. 2)

The marketing authorisation holder in the EU should continuously monitor the safety of their medicinal products and inform the authorities of any new information that might have an impact on the marketing authorisation.

When the marketing authorisation holder in the EU becomes aware of an emerging safety issue from any source, they should notify it in writing to the competent authority(ies) of Member State(s) where the medicinal product is authorised and to the EMA to the mailbox “[email protected]”. This should be done as soon as possible and no later than 3 working days after establishing that a validated signal or a safety issue from any source meets the definition of an emerging safety issue.

When a marketing authorisation holder, based on their assessment of a signal detected through EudraVigilance monitoring, and which does not meet the conditions outlined in Guideline on good pharmacovigilance practices (GVP): Module IX – Signal management (Rev. 1) IX.C.4.1. and IX.C.4.2., concludes that further analysis of the signal by the competent authorities is required, they should complete the standalone signal notification form available on the European medicines web-portal and send it to the EMA using the mailbox “[email protected]” and to the competent authorities in Member States where the medicinal product is authorised18. This should be done as soon as possible and no later than 30 days after the marketing authorisation holder has completed their assessment and concluded that further analysis by the competent authorities is required.

Guidance on regulatory requirements and on the monitoring and reporting processes for signals is available in good pharmacovigilance practices (GVP) Module IX on signal management.

EMA and the European Commission have agreed transitional arrangements to streamline the monitoring of EudraVigilance by MAHs. During a pilot period of one year, MAHs of the active substances included in the List of active substances involved in the pilot on signal detection in EudraVigilance by marketing authorisation holders  will have to monitor them in EudraVigilance and inform EMA and national competent authorities of validated signals with their medicines. These transitional arrangements do not apply to obligations on simplified reporting and management of individual case safety reports (see Good pharmacovigilance practices (GVP) Module VI and EudraVigilance change management).

All other MAHs also have access to EudraVigilance data and can integrate the data into their own signal management processes. However, during the pilot period they will have no obligation to continuously monitor EudraVigilance and inform the regulatory authorities of validated signals.

After one year, EMA will base the next phase of implementation on experience gained through the pilot.

The EMA is supporting MAHs in using the new EudraVigilance system through targeted e-learning, face-to-face training, webinars and information days.

FOR FUTHER INFORMATION

• regarding Post-Authorisation module please contact Pharmacovigilance and Poison Information Unit, e-mail: [email protected]
• regarding Clinical Trials module please contact Pharmacovigilance and Poison Information Unit, e-mail: [email protected].