Pharmaceutical Administration and Regulations in Japan - Nihs

advances, a Health Sciences Council
Research Project entitled “Research on
Quality, Efficacy, and Safety Evaluation
Methods for Biosimilars” was established
with funding from MHLW, and “Policies on
Assurance of Quality, Efficacy, and Safety of
Biosimilars” were formulated (Notification No.
0304007 of the Evaluation and Licensing
Division, PMSB dated March 4, 2009).
Biosimilars are defined as drugs developed
by different marketers as drugs with the
same quality, efficacy, and safety as
biotechnological products already approved
as drugs with new active ingredients in
Japan. “Biosimilar” does not mean that the
drug has exactly the same quality with the
original biotechnological product, but that
they are highly similar in quality and
characteristics and even if there are
differences in quality and characteristics, the
differences can be scientifically judged not
leading to any unintended effects on the
efficacy and safety profiles of the final
product. To prove the comparability,
appropriate studies are necessary based on
the concepts in the ICH Q5E guidelines
“Comparability of Biotechnological/ Biological
Products Subject to Changes in their
Manufacturing Process.” It is also
necessary to evaluate the comparability of
biosimilars using clinical studies.
Q&A on “Policies on assurance of quality,
efficacy, and safety of biosimilars” were
Pharmaceutical Regulations in Japan:
published in an Office Communication dated
July 21, 2009. Views of the regulatory
authorities on timing, definitions of equivalent
products, evaluations of comparability,
development of formulations and test
methods, and safety evaluations for
biosimilar applications are included.
5.4 Public Disclosure of Information on
New Drug Development
A notification concerning publication of
information on new drug approvals was
issued (No. 1651 of the Evaluation and
Licensing Division, PMSB dated November
11, 1999), and New Drug Approval
Information Packages containing summary
reviews prepared by the MHLW and
nonclinical and clinical data submitted by the
applicant have been published. Thereafter,
the methods of submitting data for application
were changed as specified in “Disclosure of
Information Concerning Approval Reviews of
New Drugs” (Notification No. 0529003 of the
Evaluation and Licensing Division, PMDA
dated May 29, 2002). Basic procedures for
submission and disclosure have also been
specified (Notification No. 0422001 of the
Evaluating and Licensing Division, PFSB
dated April 22, 2005, Notification No. 042204
of the PMDA dated April 22, 2005, and
Notification No. 1126005 of the Licensing and
Evaluation Division of PFSB dated November
26, 2007).
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