Pharmacovigilance and Risk Management in Japan
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Pharmacovigilance in Japan has traditionally been characterized by a small number of spontaneous reports of suspected adverse drug reactions .
Pharmacovigilance
and Risk Management in Japan
INTRODUCTION
Pharmacovigilance
in Japan has traditionally been characterized by a small number of spontaneous
reports of suspected adverse drug reactions (ADRs). Recently, however, there
has been a dramatic increase in the number of ADRs following the
implemen-tation of complex post-approval safety procedures. For example, the
drug company has long had the legal duty to conduct the ‘Drug Use
Investigations’ (DUIs), which involves physicians registering thou-sands of
patients treated with newly launched products to monitor and report any
suspected ADRs (Tanaka et al., 2002).
In the last decade, however, a rapid improvement
of the spontaneous reporting system (SRS) took place and the role of the DUIs
has been changed. The change will be further accelerated by the recent
implementation of the international guideline on the pharmacovigilance planning
for which agree-ment has been reached at the International Confer-ence on
Harmonization of Technical Requirements for Registration of Pharmaceuticals for
Human Use (ICH). In this article, some of the other new trends associated with
the recent amendment of Pharmaceu-tical Affairs Law (PAL) as well as the
current status and future problems for risk management in Japan will be
described.
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