NDA. At this stage, within six months after appli-
cation, a hearing is generally held between the
reviewers and the sponsor, which may today, be
accompanied by its own experts.
Another ‘follow-up’ meeting is organized
between the reviewers and the specialists, and a
second review report is finalized. The report is
transferred to the Evaluation and Licensing Divi-
sion of the PFSB. After a careful reading, the report
will be circulated to the Committee on New Drugs
of the PAFSC.
When the subcommittees are satisfied with the
review report, the dossier goes back to the PFSB
with a recommendation for approval. The minister
will officially grant the New Drug Approval to the
pharmaceutical company, through the prefecture.
Around 18–24 months are necessary to obtain
a new drug approval if there are no special issues,
6 months for a quasi-drug, 3 months for cosmetics
and 12 months for a medical device.
A New Drug Approval Information Package is
prepared from this report, and is published, avail-
able to medical institutions.
Summary of the product characteristics
The data sheet is called the ‘package insert’ in
Japan, as it can be found in the drug packaging.
The data sheet is drafted by the company and
checked and completed by the authorities after
the NDA review and the recommendation for
approval. The content has been defined by the
MHLW notification, and was revised in May
- Besides general information on the product,
the most important entries are warnings, precau-
tions and contraindications, and a list of adverse
events quantitatively reported. These entries will
be revised if necessary, with the safety data regu-
larly analyzed for the periodic safety update report;
however, anad hocrevision is made at any time in
case of serious events.
NHI price fixing
Prescription drugs are listed on the National Health
Insurance Drug Price List in order to be reimbursed
under the National Health Insurance Program. The
price is fixed by a commission, including medical
doctors, consumers, Central Social Insurance
Medical Council representatives (‘Chuikyo’ in
Japanese). Recent available treatments serve as
price references and premiums of 3–100% are
added to compensate for novelty and clinical
advantages. The NHI price needs two to three
months after the drug approval to be listed on
the drug tariff. The product can be launched the
following day.35.6 Post-approval activities
From the first day of its launch, the drug enters the
PMS period until the end of its marketing life
cycle. Besides phase IV trials, the regulation of
which are under reorganization and which should
meet GCP standards, post-approval activities
mainly aim at ensuring the new drug safety and
efficacy. For such purposes, a surveillance system
has been settled by the PAL. It consists of three
different types of investigations: the ARD
collecting system; the Reexamination and the
Re-evaluation. Quality standards for those three
activities are defined in by GPMSP (cf. earlier
section in this chapter).PMS organization
Several systems allow the collection of drug
adverse events and their assessment by the
MHLW as shown in Figure 35.7:ADR Monitoring System. Voluntary reports on
ADRs are sent to the MHLW from around 3000
facilities designated by the MHLW, including
national hospitals, and university and municipal
hospitals; it is also called the ‘hospital monitor-
ing system’.Pharmacy Monitoring System. This is a similar
system, collecting ADRs related to non-pre-
scription drugs, by designated pharmacies.
Around 2800 pharmacies report ADRs to the
MHLW.504 CH35 JAPANESE REGULATIONS