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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