Role of Academia and Non-Governmental Bodies in the Future Pharmacovigilance in Japan

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Chapter: Pharmacovigilance: Pharmacovigilance and Risk Management in Japan

Under the strict and somewhat intricate regulations concerned with post-approval safety, pharmacovigilance is generally regarded as the activity performed almost exclusively by the regulatory body in Japan.


ROLE OF ACADEMIA AND NON-GOVERNMENTAL BODIES IN THE FUTURE PHARMACOVIGILANCE IN JAPAN

Under the strict and somewhat intricate regulations concerned with post-approval safety, pharmacovigilance is generally regarded as the activity performed almost exclusively by the regulatory body in Japan. For instance, while Prescription–Event Monitoring in Japan was welcomed with a certain degree of enthusiasm during the pilot study (Kubota, 1999; Tanaka et al., 2002), particularly among pharma-cists, the activity has since been moderated. This is probably because direct funding from the MHLW was only available during the pilot study. However, more commitment of academic and non-governmental bodies to drug safety may be required in the near future. Indeed, in the six new enterprises by the regulatory bodies given in the previous section, many health professionals and specialists have already been involved. The activity of academia and/or non-governmental research bodies may also be required in the new type of investigations conducted by the drug companies under the regu-lations of the E2E guideline and GPSP. For exam-ple, in both of the two examples described in the section ‘The new type of investigations using pharmacoepidemiologic methods in Japan’, special-ists, health professionals and/or scientific asso-ciations played an essential role in conducting the study.

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