Drug Delivery System
Online ISSN : 1881-2732
Print ISSN : 0913-5006
ISSN-L : 0913-5006
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Volume 29, Issue 3
The current status and future issues on the regulatory science researches of advanced medicine
Displaying 1-11 of 11 articles from this issue
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[Feature articles] "The current status and future issues on the regulatory science researches of advanced medicine" Editor:Kumiko Sakai-Kato
  • [Foreword]The current status and future issues on the regulatory science researches of advanced medicine
    Kumiko Sakai-Kato
    2014 Volume 29 Issue 3 Pages 187
    Published: July 20, 2014
    Released on J-STAGE: October 21, 2014
    DOIhttps://doi.org/10.2745/dds.29.187
    JOURNAL FREE ACCESS
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  • [Opinion]Expectation for regulatory science
    Mitsuru Hashida
    2014 Volume 29 Issue 3 Pages 188
    Published: July 20, 2014
    Released on J-STAGE: October 21, 2014
    DOIhttps://doi.org/10.2745/dds.29.188
    JOURNAL FREE ACCESS
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  • Regulatory science oriented to development of innovative medical products in the National Institute of Health Sciences
    Toru Kawanishi
    2014 Volume 29 Issue 3 Pages 190-199
    Published: July 20, 2014
    Released on J-STAGE: October 21, 2014
    DOIhttps://doi.org/10.2745/dds.29.190
    JOURNAL FREE ACCESS
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    Importance of regulatory science(RS) in development of innovative medical products is pointed out in the fundamental policy papers by the Cabinet Office, and the promotion of RS is enshrined in Act on Promotion of Development of Medical Products for Public Health which have recently passaged in the Diet. The pharmaceuticals-related divisions in NIHS have began RS research for promoting improvement in developing environment of innovative medical products since 2012. Nano-medicines, fully engineered protein drugs, nucleic acid drugs, gene-therapy drugs, cell-therapy products, tissue-engineered medical products and so on have been selected as innovative medical products, and the point-to-consider documents for evaluating mainly quality and non-clinical safety of these products will be developed. In addition, the requirements for the first-in-human trial will be also framed, especially from the standpoints of quality and non-clinical safety evaluation.
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  • Efforts such as regulatory science research in Pharmaceuticals and Medical Devices Agency (PMDA)
    Yasushi Jotatsu
    2014 Volume 29 Issue 3 Pages 200-206
    Published: July 20, 2014
    Released on J-STAGE: October 21, 2014
    DOIhttps://doi.org/10.2745/dds.29.200
    JOURNAL FREE ACCESS
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  • New Japanese regulatory framework and scientific hurdles for translation of regenerative/cellular therapies
    Hitomi Muraoka, Yoji Sato
    2014 Volume 29 Issue 3 Pages 207-216
    Published: July 20, 2014
    Released on J-STAGE: October 21, 2014
    DOIhttps://doi.org/10.2745/dds.29.207
    JOURNAL FREE ACCESS
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    In 2013, the Japanese Diet passed the Regenerative Medicine Promotion Act and the Act Regarding Ensuring Safety of Regenerative Medicine (the "Regenerative Medicine Safety Act"), as well as the revisions to the Pharmaceutical Affairs Act (new PAA). One of the aims of the new/revised Acts is to promote the development and translation of and access to regenerative/cellular therapies. In the new PAA, a cell-processed product for regenerative/cellular therapy is defined as a "regenerative medical product", a product distinct from pharmaceuticals and medical devices, allowing regenerative medical products to obtain a conditional and time-limited marketing authorization much earlier than that under the conventional system. The Regenerative Medicine Safety Act enables medical institutions/hospitals to outsource cell processing to companies. This minireview provides perspectives on the new regulatory framework and scientific hurdles for translation of regenerative/cellular therapies.
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  • The initiatives for regulatory science researches of nanomedicines
    Hideyoshi Harashima, Hidetaka Akita, Kumiko Sakai-Kato, Takehiko Ishii ...
    2014 Volume 29 Issue 3 Pages 217-225
    Published: July 20, 2014
    Released on J-STAGE: October 21, 2014
    DOIhttps://doi.org/10.2745/dds.29.217
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    Nanomaterials often have physical, chemical, or biological properties that are different from those of bulk materials. These properties may have potential impacts on a variety of products, and nanotechnology application to pharmaceuticals is a typical such example. Because the unique size-specific interaction with biological systems or biodistribution may have significant impacts on the efficacy and safety of nanomedicines, regulatory science researches of nanomedicines are required. We have been conducting the formulation study, and nonclinical pharmacokinetics, pharmacodynamics, toxicology, and clinical studies of the polymeric micelles and lipid nanoparticles which are designed to ensure high stability in vivo and to optimize the pharmacokinetics. In this review, we introduce our initiatives for regulatory science researches of nanomedicines.
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  • DDS: development issues and regulatory science.
    Hiroaki Kasukawa
    2014 Volume 29 Issue 3 Pages 226-235
    Published: July 20, 2014
    Released on J-STAGE: October 21, 2014
    DOIhttps://doi.org/10.2745/dds.29.226
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    Drug delivery systems (DDS) can provide new, important technologies that lead to more effective and safer treatments while having improved cost-effectiveness, and have been expected to drive the innovation of business models of the pharmaceutical industry. Continual development of effective DDS preparations by pharmaceutical companies is necessary, given that the technologies will inevitably become dominant issues in the field of medicinal treatment as well as being essential for the growth of the pharmaceutical industry. Therefore, implementation of regulatory structures and creation of an environment that will activate the development of DDS preparations by pharmaceutical companies are required. We then discuss how important issues relating to the development of DDS preparations should be improved from the points of view of regulatory science and pharmacoeconomics in this manuscript.
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Recent advancements in instruments used for DDS research
Serial:Front line of DDS development in pharmaceutical industries
"Young square"(mini review)
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