Skip to main content

Advertisement

SpringerLink
Log in

Global Regulatory Landscape

  • Mini-Review
  • Theme: Continuous Manufacturing of Pharmaceutical Products
  • Published:
AAPS PharmSciTech Aims and scope Submit manuscript

Abstract

Continuous manufacturing (CM) of pharmaceuticals is a rapidly growing approach in the production of active pharmaceutical ingredients and finished products. The European Medicines Agency, the US Food and Drug Administration, and the Pharmaceuticals and Medical Devices Agency have independently stated their support for the introduction of CM and provided opportunities for early dialog between industries and regulatory agencies. This paper describes the current regulatory landscape and the regulatory harmonization.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Similar content being viewed by others

References

  1. Allison G, Cain YT, Cooney C, Garcia T, Bizjak TG, Holte O, et al. Regulatory and quality considerations for continuous manufacturing May 20-21, 2014 Continuous Manufacturing Symposium. J Pharm Sci. 2015;104(3):803–12.

    Article  CAS  Google Scholar 

  2. Byrn S, Futran M, Thomas H, Jayjock E, Maron N, Meyer RF, et al. Achieving continuous manufacturing for final dosage formation: challenges and how to meet them May 20-21, 2014 Continuous Manufacturing Symposium. J Pharm Sci. 2015;104(3):792–802.

    Article  CAS  Google Scholar 

  3. Konstantinov KB, Cooney CL. White paper on continuous bioprocessing. May 20-21, 2014 Continuous Manufacturing Symposium. J Pharm Sci. 2015;104(3):813–20.

    Article  CAS  Google Scholar 

  4. Page T, Dubina H, Fillipi G, Guidat R, Patnaik S, Poechlauer P, et al. Equipment and analytical companies meeting continuous challenges. May 20-21, 2014 Continuous Manufacturing Symposium. J Pharm Sci. 2015;104(3):821–31.

    Article  CAS  Google Scholar 

  5. Myerson AS, Krumme M, Nasr M, Thomas H, Braatz RD. Control systems engineering in continuous pharmaceutical manufacturing. May 20-21, 2014 Continuous Manufacturing Symposium. J Pharm Sci. 104(3):832–9.

  6. Baxendale IR, Braatz RD, Hodnett BK, Jensen KF, Johnson MD, Sharratt P, et al. Achieving continuous manufacturing: technologies and approaches for synthesis, workup, and isolation of drug substance. May 20-21, 2014 Continuous Manufacturing Symposium. J Pharm Sci. 2015;104(3):781–91.

    Article  CAS  Google Scholar 

  7. Srai JS, Badman C, Krumme M, Futran M, Johnston C. Future supply chains enabled by continuous processing-opportunities and challenges. May 20-21, 2014 Continuous Manufacturing Symposium. J Pharm Sci. 2015;104(3):840–9.

    Article  CAS  Google Scholar 

  8. Nepveux K, Sherlock JP, Futran M, Thien M, Krumme M. How development and manufacturing will need to be structured-heads of development/manufacturing. May 20-21, 2014 Continuous Manufacturing Symposium. J Pharm Sci. 2015;104(3):850–64.

    Article  CAS  Google Scholar 

  9. Lee SL, O’Connor TF, Yang X, Cruz CN, Chatterjee S, Madurawe RD, et al. Modernizing pharmaceutical manufacturing: from batch to continuous production. J Pharm Innov. 2015;10:191–9.

    Article  Google Scholar 

  10. PMDA Innovative Manufacturing Technology WG. PMDA Views on Applying Continuous Manufacturing to Pharmaceutical Products for Industry (provisional draft). https://www.pmda.go.jp/files/000223712.pdf. Accessed 15 Jul 2018.

  11. Nasr MM, Krumme M, Matsuda Y, Trout BL, Badman C, Mascia S, et al. Regulatory perspectives on continuous pharmaceutical manufacturing: moving from theory to practice: September 26-27, 2016, International Symposium on the Continuous Manufacturing of Pharmaceuticals. J Pharm Sci. 2017;106:3199–206.

    Article  CAS  Google Scholar 

  12. Matsuda Y, Aoyama A, Ikematsu Y, Ishii R, Inoue K, Ohta T, et al. Points to Consider Regarding Continuous Manufacturing http://www.nihs.go.jp/drug/section3/AMED_CM_PtC.pdf. Accessed 15 Jul 2018.

  13. Matsuda Y, Aoyama A, Aoyama E, Ikematsu Y, Inoue K, Ohta T, et al. State of Control in Continuous Pharmaceutical Manufacturing http://www.nihs.go.jp/drug/section3/AMED_CM_CONTROLST.pdf. Accessed 15 Jul 2018.

  14. Regulatory Harmonization and Convergence. https://www.fda.gov/BiologicsBloodVaccines/InternationalActivities/ucm271079.htm . Accessed 17 Oct 2018.

Download references

Acknowledgements

I thank Sau L. Lee (US FDA) and Dolores Hernan (EMA) for sharing information about ETT and PAT team.

Author information

Authors and Affiliations

  1. Pharmaceuticals and Medical Devices Agency (PMDA), Shin-Kasumigaseki Bldg. 3-3-2, Kasumigaseki, Chiyoda-ku, Tokyo, 100-0013, Japan

    Yoshihiro Matsuda

Authors
  1. Yoshihiro Matsuda
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Yoshihiro Matsuda.

Additional information

Guest Editors: James DiNunzio, Christine Moore, and Robert Meyer

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

The views expressed in this manuscript by the author are personal and do not necessarily reflect the official position of the regulatory authority.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Matsuda, Y. Global Regulatory Landscape. AAPS PharmSciTech 20, 2 (2019). https://doi.org/10.1208/s12249-018-1230-x

Download citation

  • Received:

  • Accepted:

  • Published:

  • DOI: https://doi.org/10.1208/s12249-018-1230-x

KEY WORDS

Search

Navigation