2．Consideration of Signal Management Process / 薬剤疫学

ABSTRACT

In the EU, signal management guideline is defined as GVP Module Ⅸ “Signal Management”, where the signal management is defined as a set of activities performed to determine whether, based on an examination individual case safety reports (ICSRs), aggregated data from active surveillance systems or studies, scientific literature information or other data sources, there are new risks associated with an active substance or a medicinal product or whether known risks have changed, as well as any related recommendations, decisions, communications and tracking. The EU signal management process includes the following activities signal detection, signal validation, signal confirmation, signal analysis and prioritisation, signal assessment and recommendation for action.WHO and FDA have also published similar guidance in various documents. Furthermore, the social medial has become another source of signal. It is also very important to review preapproval clinical trial data. This is because, in recent years, there are increased number of drugs with a major problem due to cardiovascular risk or suicide, but such signals often appeared in clinical trial data.Traditional qualitative signal detection method is fundamental to signal detection. However, for regulators that have to monitor all drugs, statistical signal detection and its prioritization are indispensable and various methods have been implemented. For pharmaceutical companies, the need for prioritization itself is small, but the concept is very helpful in the planning of subsequent measures.In signal evaluation, post-authorization safety study in EU and postmarketing requirement in FDA are very important. For regulatory notification of recommended actions, one should consider signal prioritization elements.In Japan, the routine pharmacovigilance activities sufficient within the scope of local GVP as the enforcement regulations of the PMR Law. But for future routine pharmacovigilance activities, we must work on signal detection and evaluation of signals which are difficult to detect including cardiovascular risk, suicide, and carcinogenesis.