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Regulatory Oversight of Gene Therapy and Cell Therapy Products in Korea

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Regulatory Aspects of Gene Therapy and Cell Therapy Products

Part of the book series: Advances in Experimental Medicine and Biology ((ASGCT,volume 871))

Abstract

The Ministry of Food and Drug Safety regulates gene therapy and cell therapy products as biological products under the authority of the Pharmaceutical Affairs Act. As with other medicinal products, gene therapy and cell therapy products are subject to approval for use in clinical trials and for a subsequent marketing authorization and to post-market surveillance. Research and development of gene therapy and cell therapy products have been progressing rapidly in Korea with extensive investment, offering great potential for the treatment of various serious diseases. To facilitate development of safe and effective products and provide more opportunities to patients suffering from severe diseases, several regulatory programs, such as the use of investigational products for emergency situations, fast-track approval, prereview of application packages, and intensive regulatory consultation, can be applied to these products. The regulatory approach for these innovative products is case by case and founded on science-based review that is flexible and balances the risks and benefits.

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Notes

  1. 1.

    Central Pharmaceutical Affairs Advisory Committee (CPAC) provides advice to an MFDS request on issues related to medicinal products. The CPAC consists of five sub-committees categorized by subject. Committee members are composed of independent outside experts (e.g., medical doctors, pharmacists, professors, statisticians, lawyers) and consumer representatives.

References

  1. Pharmaceutical Affairs Act

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  2. Medical Device Act

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  3. Human Tissue Safety and Control Act

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  4. Bioethics and Safety Act

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  5. Enforcement Rule of Medicinal Products Safety

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  6. Regulation on Review and Authorization of Biological Products

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  7. Regulation on Approval of Investigational New Drug Application for Medicinal Products

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  8. MFDS website (www.mfds.go.kr/index.do?mid=616)

  9. Regulation on Designation of Orphan Drugs

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  10. Regulation on Pre-review of Application Documents for Medicinal Products

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  11. Regulation on Re-examination of Medicinal Products

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  12. Regulation on Re-evaluation of Medicinal Products

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  13. Guideline on Manufacture and Quality Control of Cell Therapy Products (2012)

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  14. Guideline on Replication Competent Virus Test for Gene Therapy Products (2005)

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  15. Guideline on Mycoplasma Test Suitable for Cell Therapy Products (2008)

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  16. Guideline on Adventitious Virus Test for Biological Products for Human Use (2010)

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  17. Korea Laws Center (www.law.go.kr)

  18. MFDS electronic service website (http://ezdrug.mfds.go.kr)

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Acknowledgment

We thank the staff in the MFDS, Mira Choi, Sungmin Kim, Kyoungsuk Choi, and Miryeong Jin, for their assistance in preparing this manuscript.

Author information

Authors and Affiliations

  1. Cell and Gene Therapy Products Division, National Institute of Food and Drug Safety (NIFDS), Ministry of Food and Drug Safety (MFDS), 187 Osongsaengmyeong 2-ro, Osong-eup, Heungdeok-gu, Cheongju-si, Chungcheongbuk-do, 361-951, South Korea

    Minjoung Choi, Euiri Han, Sunmi Lee, Taegyun Kim & Won Shin

Authors
  1. Minjoung Choi
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  2. Euiri Han
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  3. Sunmi Lee
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  4. Taegyun Kim
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  5. Won Shin
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Corresponding author

Correspondence to Won Shin .

Editor information

Editors and Affiliations

  1. Cell Biology and Neurosciences, Istituto Superiore di Sanità, Rome, Roma, Italy

    Maria Cristina Galli

  2. Center for Biologics Evaluation and Research/Office of Cellular, Tissue, and Gene Therapies, Pharmacology/Toxicology Branch, US Food and Drug Administration, Silver Spring, Maryland, USA

    Mercedes Serabian

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© 2015 American Society of Gene and Cell Therapy

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Choi, M., Han, E., Lee, S., Kim, T., Shin, W. (2015). Regulatory Oversight of Gene Therapy and Cell Therapy Products in Korea. In: Galli, M., Serabian, M. (eds) Regulatory Aspects of Gene Therapy and Cell Therapy Products. Advances in Experimental Medicine and Biology(), vol 871. Springer, Cham. https://doi.org/10.1007/978-3-319-18618-4_9

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