medical departments for clinical R&D and to
assess ADRs. The predominant role of the inves-
tigators will decrease. The drug evaluation system
by the authorities will have to be modified as well,
it already shows however a strong will to a more
scientific evaluation with the creation of the Japa-
nese Drug Agency (PMDA).
The move is not limited to drug research and
development. Many other fields are involved in this
general evolution of the Japanese healthcare sys-
tem: for example, the separation of prescription
from dispensing (‘bungyo’) made recent progress;
an important NHI price reform is under discussion,
which could be a step toward a large change of the
health insurance system.
In conclusion, the rapid evolution of the drug
regulations may invalidate this chapter within a
few years, but it is important for the pharmaceutical
industry to understand that the whole drug envir-
onment moves toward international standards
underthe pressure of the scientific progress, quality
requirements and economical issues. It represents a
chance to integrate Japan in the conception of the
global dossier, for which ICH has already laid the
foundations.
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