Pharmacovigilance and Risk Management in Japan

| Home | | Pharmacovigilance |

Chapter: Pharmacovigilance: Pharmacovigilance and Risk Management in Japan

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.

Contact Us, Privacy Policy, Terms and Compliant, DMCA Policy and Compliant

TH 2019 - 2022 pharmacy180.com; Developed by Therithal info.