Pharmacovigilance and Risk Management / 薬剤疫学

ABSTRACT

Therapeutic Risk Management is indispensable in accelerating the approval of new medicines and getting them successfully launched. Regulatory authorities in Europe and the United States released a series of Guidance documents on how to implement Risk Management in 2005. While in Japan, the Investigative Commission for Promptly Providing Safety and Effective Pharmaceuticals made a similar proposal in 2007. Also, since the implementation of ICH E2E Pharmacovigilance Planning in 2005, safety measures have been prepared in Japan for individual drugs. But it is now time to take comprehensive safety countermeasures from the view point of Risk Management. This paper introduces Risk Management procedures in Europe and the United States and considers imminent challenges Japan has to tackle.