Principles and Practice of Pharmaceutical Medicine

Medical Device Monitoring System. Another
similar system reports to the MHLW the pro-
blems encountered with medical devices.

Manufacturers (and wholesalers)should also
report ADRs to the MHLW, according to the
Law.

The type of ADR to report and the time limits
are defined by the international guidelines on
Safety Data Management. In addition, periodic
safety update reports are sent to the MHLW with
respect to these international standards. Tradi-
tionally, in Japan, ADRs are classified into three
grades (mild, moderate, severe), according to
severity criteria, and into function of the body
apparatus.
The MHLW collects and exchanges ADR infor-
mation through other sources:

WHO International Drug Monitoring Program.

Relations with foreign health authorities, such as
the FDA in the United States and the EMEA in
the European Union.

Survey of medical journals.

Relations with universities and national insti-
tutes, and so on.

The safety information collected on a drug is

assessed by the PAFSC (subcommittee on ADRs

evaluation), and when necessary, the MHLW

instructs the manufacturer to take measures

such as

the revision of the data sheet (warning, dose, etc.);

to conduct new investigation in animals or in

humans;

to discontinue import or manufacturing;

to recall drugs from the market.

Reexamination

The Reexamination system is part of, and comple-

mentary to, the PMS. After a certain period of mar-

keting, safety and efficacy data are reexamined in the

light of data collected during this period, which is

six years for new drugs (extension up to 8 years

updet discussion), combined drugs and new

administration route;

four years for a new indication, or a new dosage;

ten years for orphan drugs.

Figure 35.7 The Japanese post-marketing surveillance system

35.6 POST-APPROVAL ACTIVITIES 505