POLICY & REGULATION
Figure 1: PMDA organisational chart
Of_f_ice of General Af_fairs/
Of_f_ice of Planning and Coordination
Auditor
Associate executive
Of_f_ice of Relief Funds
Auditor
director
Of_f_ice of Review Administration
Senior Of_f_ice of Review Management
executive Review department
director
Of_f_ice of New Drugs I-IV
Director (Center for Of_f_ice of Biologics I-II
CEO
Product Evaluation)
Of_f_ice of OTC/Generic Drugs
Of_f_ice of Medical Devices
Associate center
(Inspections such as
directors
Of_f_ice of Conformity Audit
GLP/GCP and GPSP)
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Executive
director
Of_f_ice of Safety
Post-marketing
Chief safety
department
of_f_icer
Executive
Of_f_ice of Compliance
director
and Standards
(GMP/QMS
Inspection)
Number of staf_f: 256 (April 2004) 319 (September 2006) 346 (2008) with approx. 900 external experts
Source: PMDA
Although driven more by commercial Dr Toyoshima went on to note that the can learn from their experience and hope
considerations, a number of multinationals populations of Japan, China and South Korea that we will be able to exchange staff in the
are already adopting this approach, aiming are seen as genetically relatively similar, future,” the CEO explained.
to more or less simultaneously develop new although some differences – and with the As part of its outreach and transparency
drugs in the major markets of the US, Europe wider Asian population – cannot be ruled efforts, the PMDA is also planning to translate
and Japan. out. This is why the PMDA sees the inclusion more regulatory documents and guidance
To help this process along, in September of some Japanese patients in multinational into English, a move it hopes may also
2007 the MHLW released a notifi cation and regional trials as necessary. Product help other regulators in Asia. For example,
on basic principles for global trials, which type might also affect precise requirements. summaries of approval reviews for two
outlined the type and quantity of Japanese “Some drugs, such as antimicrobials, may not products have already been made available
data required. Again, prior consultation with be affected so much by ethnic factors,” the through the agency’s website.
the agency is strongly recommended to offi cial said.
ensure appropriate study protocols. “We The hope is that the new discussions will
biosimilars
want to encourage discussions at an early yield fi ndings of mutual benefi t. Although
In common with many other countries, Japan
stage and are willing to consider products there is no harmonisation of technical
is still working on appropriate regulations for
case-by-case, depending on type,” requirements between the three countries’
generic versions of biological products, or
Dr Toyoshima explained. respective regulators as yet, data from one
biosimilars. The health ministry is drawing up
He pointed to a major related outreach should provide useful support for the other.
a proposed guideline on what Dr Toyoshima
initiative involving other regulators in China Some companies are beginning to explore
conceded was a diffi cult and challenging issue.
and South Korea, with which the PMDA has this approach in their regional clinical
“Unlike generic chemical drugs, minor
now started discussing the infl uence of ethnic programmes, with several now performing
variations in protein structure can have a
factors on clinical and other data. This has trials in the three countries in support of
potentially big impact on pharmacokinetics
long been a contentious area, although the planned submissions in Japan.
and safety, which is why we must look
International Conference on Harmonisation’s As one of the core participants, Japan has
carefully at the appropriate regulation of
(ICH) E5 guideline on intrinsic and extrinsic been a keen proponent of the global ICH
biosimilars,” he explained. While variations for
ethnic factors addresses many of the main regulatory harmonisation process and is
some products such as growth factors may
issues. encouraging other Asian countries to adopt
not be that worrisome, for others it might be
Explaining that: “we need stronger the initiative’s guidelines. As to whether there
critical, he added.
collaboration with other east Asian nations,” might be more harmonisation of regulations
Opinions are being solicited on basic
Dr Toyoshima said that the three countries between Asian countries in the future,
proposals, which could lead to a basic
began a dialogue in April, under which they Dr Kondo commented: “Personally I believe
guideline being drawn up by the end of 2008.
will share clinical data and conduct joint this is possible, but it is likely to take time and
Until then, the policy is to treat products on a
studies to elucidate better the infl uence of each country will want to retain their
case-by-case basis, aided by close discussions
ethnic differences on factors such as safety own systems.”
with applicants.
and effi cacy. Director general-level meetings As part of its expansion, the PMDA would
between the three countries will be held also like to increase its interactions with peer
annually on a rotational basis, with China to agencies such as the US FDA and Europe’s
host the 2009 meeting and South Korea the EMEA, with which it has already established Ian Haydock is Scrip’s Asia editor.
one in 2010. good links and exchanges information. “We
www.scripnews.com/supplements Scrip 100
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