Scrip 100 December 2008

POLICY & REGULATION
Japan’s PMDA puts
its house in order
Dr Tatsuya Kondo and Dr Satoshi Toyoshima of
the Japanese medicines regulator talk exclusively to
Ian Haydock about some of the issues they face
The steady increase in the number of
DR TATSUYA KONDO DR SATOSHI TOYOSHIMA
reviewers (some of whom have joined from
S
ince it was set up in April 2004, being granted to new products, said industry) and the rising number of clinical
bringing together drug and medical Dr Satoshi Toyoshima, director of the agency’s trial consultations already appear to be paying
device regulatory functions then split centre for product evaluation. Under these,
dividends. The agency actively promotes a
between various government bodies, Japan’s approval holders are required to carry
consultation process with applicants and has
Pharmaceuticals and Medical Devices Agency out comprehensive (usually all-patient)
now largely overcome the bottleneck in the
(PMDA) has not always elicited the kindest postmarketing studies for novel therapies in
system that existed several years ago. Nearly
of comments from industry applicants.
their actual clinical setting and “to ensure their
300 such discussions took place in ﬁ scal 2006.
Frustrations have been expressed at lengthy
safety to society”, he said. The programmes can
According to internal PMDA data, median
review times, non-transparent procedures and
last for one or two years and – while companies
total review times (which include stoppages
difﬁ culties in securing slots for consultations.
might grumble about the additional cost – the
for questions and additional data) fell from
But helped by a gradual increase in staff,
PMDA sees them as an integral component of
22.4 months in ﬁ scal 2005 (ended March 31st,
and various initiatives to try and address such
its regulatory arsenal.
2006) to 20.1 months in ﬁ scal 2007. Actual
complaints, things have improved markedly
Dr Kondo added that the PMDA is also
review times (excluding stoppages) over the
over the past few years. The tone of feedback
taking other concrete steps to cut review times
same period fell slightly, from 12.0 months
from the industry has recently become much
while making sure that its assessments ensure
to 11.6 months. While these gains might be
more positive, although of course applicants
product safety, efﬁ cacy and quality. Continued
modest, at least things appear to be moving
will always want to see further reductions in
increases in the number of reviewers are
in the right direction as procedures under the
review times.
seen as critical to this effort, although the
new agency become established.
Dr Tatsuya Kondo holds a similar view that
PMDA is notably keen to point out at industry
the quest to improve performance is far from
conferences that it already manages to do a lot
Dr Toyoshima explained that another
with resources that are very limited compared
positive change had been the adoption
over. One of the biggest challenges facing
with some other leading regulatory bodies.
of product review/management teams,
the regulator’s new CEO, appointed in April
which handle procedures from clinical trial
2008, is Japan’s much talked about “drug lag”
recruitment drive
consultation through to approval reviews.
problem, whereby many major new therapies
As of April 2008, the agency employed
“These help to improve the consistency and
do not reach the local market until several
a modest 277 people in its review ofﬁ ce
speed of reviews. But I want to stress that
years after they have been approved in the US
(including for generics, OTCs and devices,
we are not only concerned with speed but
and Europe.
and for GLP/GCP inspections), an increase of
with the quality of the staff and of the review
Speaking at the PMDA’s ofﬁ ces in Tokyo’s
71 over the previous year, out of a total staff
process itself,” he said.
Kasumigaseki district, he declared: “Patients
of 426. The aim is to increase the number of
in Japan still do not have full access to new
new drug reviewers by more than 200 over
international scope
drugs and they want us to approve products
the three years from April 2007, which will
Earlier in 2008, the PMDA published a “points
quickly and safely. This is an issue that should
virtually double the number of such staff over
to consider” document outlining the type of
be confronted squarely.” Dr Kondo can claim
this period. The agency’s total workforce is
information the agency is looking for from
to have a good idea of patients’ expectations
expected to rise to 582 by March 2010.
applicants and how this should be assessed by
when it comes to the newest and most
“We are on target to achieve these planned
its review teams. An English translation was
effective drug treatments, having spent 40
increases,” Dr Kondo said, although he
made available through its website.
years as a practising neurosurgeon and
conceded that ﬁ nding suitably qualiﬁ ed people
“We believe this will be helpful to
hospital director, and he is looking to bring this
is not always easy. “We have had around 1,000
applicants and to improving the speed and
physician’s perspective to his key role at the
applicants so far, but are looking for people with
quality of the review process,” Dr Toyoshima
agency.
high capabilities. After hiring, it takes around a
said, noting that the document lays out basic
Noting that the PMDA has a duty to try and
couple of years for new staff to maximise their
principles and checkpoints for reviewers,
address the drug lag problem, he explained
contribution following training, and we are now
with the emphasis on clinical data. It also
that the overall goal is eventually to cut overall
placing a great deal of emphasis on this.” stresses the need for ﬂ exibility and close
approval times to around 12 months for
The PMDA, along with the ministry of health, liaison with applicants.
standard new drug reviews and to nine months
labour and welfare (MHLW) – with which it Both of the senior ofﬁ cials see Japan’s
for the priority reviews granted to high-need
co-ordinates closely on regulatory matters – is increased participation in international
therapies. “Looking at the data for last ﬁ scal year,
also seeking a big increase in the number of clinical trial programmes as another effective
it was clear we made good progress in the area
staff dedicated to reviewing side-effect reports way to reduce drug lag. The aim here is to
of priority reviews,” Dr Kondo said. and postmarketing safety data. The aim is to
generate clinical data sufﬁ cient for Japanese
As a trade-off for faster reviews, a greater better assess data coming in from both Japan
approval by including sites in Japan within
number of conditional approvals are now and overseas and to take any necessary action.
global programmes.
68
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