Simplified Adverse Event Reporting in Europe – Are You Prepared for the Switch Over?
Since the introduction of the pharmacovigilance legislation in 2010, a commitment to a simplified approach to adverse event reporting was introduced by the EMA (Articles 107(3) and 107a(4) of Directive 2001/83/EC). This approach would only apply however following an independent audit of the EudraVigilance database.
Ad interim, the adverse reaction reporting is based on the provisions set out in Article 2(4), Article 2(5) and Article 2(6) of Directive 2010/84/EU and in line with national legislation and guidance where applicable. This is referred to as the so-called ‘Interim period’ which continues to be in place.
What Are The Interim Arrangements for Simplified Adverse Event Reporting?
The arrangements for adverse reporting in the so called ‘Interim period’ are detailed in both GVP module VI and in an EMA guidance document. Depending on the occurrence country, how an adverse event should be reported varies greatly. In Ireland for example, a serious adverse event should only be reported to the HPRA. In Belgium, it should only be reported to EudraVigilance. In Hungary it should be reported to both the NCA and to EudraVigilance.
Six months following the announcement of the successful outcome of the independent audit of EudraVigilance database, the so called ‘simplified reporting’ rules will apply henceforth. Current EMA estimates for the switch over put this at Q4 2017. What will the new rules mean for MAHs? Thankfully it means things do become much simpler – all ICSRs that occur in the EEA, be they serious or non-serious are simply reported to EudraVigilance according to the existing 15 and 90 day timeframes. MAHs no longer need to navigate the maze of country specific reporting requirements mandated during the interim period. For more information refer to the business process map in Figure 1.
Figure 1 – Business process map – Suspected adverse reaction reporting in EU – Final arrangements (Copyright European Medicines Agency. GVP Module VI)
MAHs who use EVWEB should undergo training on EVWEB and the new ICH E2B(R3) format to familiarise with new functionalities and changes as there will be a new interface and improved functionalities. MAHs may use the E2B(R3) format for reporting of ICSRs to EV or continue to report based on the E2B(R2) format as no deadline has yet been established for discontinuation of R2.
If you would like assistance with this, then please get in touch. Call us on 00353 52 61 76 706 or complete your details below and we will get back to you.
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