Accurate and timely safety/ pharmacovigilance (PV) reporting is required to avoid embarrassing Warning Letters and potentially huge fines and penalties. Recently, the reporting format was revised, and the new structure, E2B(R3), has been finalized and is targeted for adoption in Europe in 2016. Also, the FDA has recently issued regulations requiring mandatory electronic reporting of ICSRs (individual case safety reports) for drugs, devices, and vaccines, effective in 2015. Marketing authorization holders (MAHs) need to start planning for these changes now or face the risk of not being in compliance when the new rules go into effect. The following are some key business issues you need to be aware of as you plan for these mandates.