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Generic Drug Product Development in Japan: Regulatory Updates During 2014–2019 and the Future

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Abstract

The growth of healthcare cost is a serious issue in many countries. Generic drug products play an essential role in reducing healthcare costs because they are less costly than the innovator drug products. The regulatory review of generic drug products in Japan is conducted by the Pharmaceuticals and Medical Devices Agency (PMDA). This report introduces the activities of the PMDA from fiscal years 2014–2019. The number of approvals of new generic drug products and partial changes was trending downward. Alternatively, the PMDA conducted six types of consultation meetings to advise on development and application; the number of consultation meetings was increasing. Moreover, during this period, the Ministry of Health, Labour and Welfare issued two basic principles for ophthalmic dosage forms and dry powder inhaler drug products and revised the guidelines for bioequivalence. Finally, the future of generic drug product development and considerations to improve their regulation were discussed. More efforts will continue to enable a more efficient and rational generic drug product development and shortening of the review period for partial change approval.

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References

  1. MHLW. Drug price calculation system. 2019. https://www.mhlw.go.jp/content/12400000/000547630.pdf. Accessed 30 May 2021. (in Japanese)

  2. Cabinet Office. Annual report on the ageing society. 2019. https://www8.cao.go.jp/kourei/english/annualreport/2019/pdf/2019.pdf. Accessed 30 May 2021.

  3. MHLW. Trends of Japanese National Healthcare Costs. 2019. https://www.mhlw.go.jp/topics/medias/year/19/dl/iryouhi_data.pdf. Accessed 30 May 2021. (in Japanese)

  4. MHLW. Trends of the prescription drug costs. 2019. https://www.mhlw.go.jp/topics/medias/year/19/dl/gaiyo_data.pdf. Accessed 30 May 2021. (in Japanese)

  5. MHLW. Survey report on generic drug use promotion roadmap. https://www.mhlw.go.jp/content/10800000/000345373.pdf. Accessed 30 May 2021. (in Japanese)

  6. MHLW. Handing of attached document for approval application of ethical drugs. 2016. https://www.pmda.go.jp/files/000210449.pdf. Accessed 30 May 2021. (in Japanese)

  7. Kuribayashi R, Matsuhama M, Mikami K. Regulation of generic drugs in Japan: the current situation and future prospects. AAPS J. 2015;17:1312–6. https://doi.org/10.1208/s12248-015-9777-x.

    Article  PubMed  PubMed Central  Google Scholar 

  8. MHLW. The basic principles of bioequivalence evaluations for generic dry powder inhaler drugs.2020. https://www.pmda.go.jp/files/000210452.pdf. Accessed 30 May 2021. (in Japanese)

  9. Kuribayashi R, Yamaguchi T, Sako H, Takishita T, Takagi K. Bioequivalence evaluations of generic dry powder inhaler drug products: similarities and differences between Japan, USA, and the European Union. Clin Pharmacokinet. 2017;56:225–33. https://doi.org/10.1007/s40262-016-0438-8.

    Article  CAS  PubMed  Google Scholar 

  10. Kuribayashi R, Myoenzono A, Takagi K, Hirota M. Current understanding of the equivalence evaluations for in vitro tests on generic dry powder inhaler drug products in Japan. Eur J Drug Metab Pharmacokinet. 2019;44:743–5. https://doi.org/10.1007/s13318-019-00561-z.

    Article  CAS  PubMed  Google Scholar 

  11. MHLW. The basic principles of the bioequivalence evaluations of the generic ophthalmic dosage forms. 2018. https://www.pmda.go.jp/files/000232768.pdf. Accessed 30 May 2021. (in Japanese)

  12. Myoenzono A, Kuribayashi R, Yamaguchi T, Ogawa T, Takagi K. Current regulation for bioequivalence evaluations of generic ophthalmic dosage forms in Japan. Eur J Drug Metab Pharmacokinet. 2020;45:697–702. https://doi.org/10.1007/s13318-020-00646-0.

    Article  CAS  PubMed  Google Scholar 

  13. MHLW. Guideline for bioequivalence studies of generic products. 2020. https://www.nihs.go.jp/drug/be-guide(e)/2020/GL1_BE_2020.pdf. Accessed 22 Sep 2021.

  14. MHLW. Guideline for bioequivalence studies of generic products for different strengths of oral solid dosage forms. 2020. https://www.nihs.go.jp/drug/be-guide(e)/2020/GL2_diffrent_strengths_2020.pdf. Accessed 22 Sep 2021.

  15. MHLW. Guideline for bioequivalence studies for formulation changes of oral solid dosage forms. 2020. https://www.nihs.go.jp/drug/be-guide(e)/2020/GL3_formation_changes_2020.pdf. Accessed 22 Sep 2021.

  16. MHLW. Guideline for bioequivalence studies for different oral solid dosage forms. 2020. https://www.nihs.go.jp/drug/be-guide(e)/2020/GL4_diffrent_doage_forms_2020.pdf. Accessed 22 Sep 2021.

  17. MHLW. Guideline for bioequivalence studies of generic products Q&A. 2020. https://www.nihs.go.jp/drug/be-guide(e)/2020/QA1_BE_2020.pdf. Accessed 22 Sep 2021.

  18. MHLW. Guideline for bioequivalence studies for different strengths of oral solid dosage forms and formulation changes of oral solid dosage forms Q&A. 2020. https://www.nihs.go.jp/drug/be-guide(e)/2020/QA2_diffrent_strengths_formation_changes_2020.pdf. Accessed 22 Sep 2021.

  19. MHLW. Guideline for bioequivalence studies for different oral solid dosage forms Q&A. 2020. https://www.nihs.go.jp/drug/be-guide(e)/2020/QA3_diffrent_doage_forms_2020.pdf. Accessed 22 Sep 2021.

  20. Kuribayashi R, Yamaguchi T, Takagi K. Modernization and strengthening of bioequivalence guidelines in Japan. Clin Pharmacokinet. 2021;60:145–51. https://doi.org/10.1007/s40262-020-00965-0.

    Article  PubMed  Google Scholar 

  21. MHLW. Guideline for biopharmaceutics classification system-based biowaivers. 2020. https://www.pmda.go.jp/files/000238767.pdf. Accessed 30 May 2021. (in Japanese)

  22. ICH. Biopharmaceutics classification system-based biowaiverS M9. 2019. https://www.pmda.go.jp/files/000232861.pdf. Accessed 30 May 2021.

  23. ICH. ICH M13 EWG work plan. 2020. https://database.ich.org/sites/default/files/M13_EWG_WorkPlan_2020_1030.pdf. Accessed 30 May 2021.

  24. MHLW. Guideline for bioequivalence studies of generic products for topical use. 2003. http://www.nihs.go.jp/drug/be-guide(e)/Topical_BE-E.pdf. Accessed 30 May 2021.

  25. FDA. Generic drug facts. 2018. https://www.fda.gov/drugs/generic-drugs/generic-drug-facts. Accessed 30 May 2021.

  26. FDA. Generic drugs: questions and answers. 2018. https://www.fda.gov/drugs/questions-answers/generic-drugs-questions-answers. Accessed 30 May 2021.

  27. EMA. QRD general principles regarding the SmPC information for a generic/hybrid/biosimilar product. 2018. https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/quality-review-documents-general-principles-regarding-summary-product-characteristics-information/hybrid/biosimilar-product_en.pdf. Accessed 30 May 2021.

  28. MHLW. Instructions for package inserts of prescription drugs. Division notification of the pharmaceutical safety and Environmental Health Bureau. 2018. http://www.phrma-jp.org/wordpress/wp-content/uploads/2019/05/PSEHB-Notification-No.0608-1_E_1.1.pdf. Accessed 30 May 2021.

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Author notes

  1. Miho Kasuga and Ryosuke Kuribayashi contributed equally to this work.

Authors and Affiliations

  1. Office of Generic Drugs, Pharmaceuticals and Medical Devices Agency, 3-3-2, Kasumigaseki, Chiyoda-ku, Tokyo, 100-0013, Japan

    Miho Kasuga, Ryosuke Kuribayashi, Takumi Ogawa, Akiko Ugi, Toru Yamaguchi & Mitsue Hirota

  2. Office of Manufacturing Quality for Drugs, Pharmaceuticals and Medical Devices Agency, 3-3-2, Kasumigaseki, Chiyoda-ku, Tokyo, 100-0013, Japan

    Kazunori Takagi

Authors
  1. Miho Kasuga
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  2. Ryosuke Kuribayashi
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  3. Takumi Ogawa
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  4. Akiko Ugi
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  5. Toru Yamaguchi
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  6. Kazunori Takagi
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  7. Mitsue Hirota
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Corresponding authors

Correspondence to Miho Kasuga or Ryosuke Kuribayashi.

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No external funding was used in the preparation of this manuscript.

Conflict of interest

Miho Kasuga, Ryosuke Kuribayashi, Takumi Ogawa, Akiko Ugi, Toru Yamaguchi, Kazunori Takagi and Mitsue Hirota declare that they have no conflict of interest that might be relevant to the contents of this article.

Authors' contributions

Miho Kasuga and Ryosuke Kuribayashi were the main writers of this article. Takumi Ogawa, Akiko Ugi, Toru Yamaguchi, Kazunori Takagi and Mitsue Hirota contributed to the fact-finding and editing for this article.

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Acknowledgements

The authors thank the Offices of Generic Drugs of PMDA for their helpful support. Also, the authors thank Enago (www.enago.jp) for the English language review.

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The views expressed in this article are those of the authors and do not necessarily reflect the official views of the Pharmaceuticals and Medical Devices Agency.

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Kasuga, M., Kuribayashi, R., Ogawa, T. et al. Generic Drug Product Development in Japan: Regulatory Updates During 2014–2019 and the Future. Eur J Drug Metab Pharmacokinet 46, 711–719 (2021). https://doi.org/10.1007/s13318-021-00720-1

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  • DOI: https://doi.org/10.1007/s13318-021-00720-1

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