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Regenerative medicine regulatory policies: A systematic review and international comparison

Author

Listed:
  • Qiu, Tingting
  • Hanna, Eve
  • Dabbous, Monique
  • Borislav, Borisov
  • Toumi, Mondher

Abstract

A small number of regenerative medicines (RMs) have received market authorization (MA) worldwide, relative to the large number of clinical trials currently being conducted. Regulatory issues constitute one major challenge for the MA of RMs.

Suggested Citation

  • Qiu, Tingting & Hanna, Eve & Dabbous, Monique & Borislav, Borisov & Toumi, Mondher, 2020. "Regenerative medicine regulatory policies: A systematic review and international comparison," Health Policy, Elsevier, vol. 124(7), pages 701-713.
    • Handle: RePEc:eee:hepoli:v:124:y:2020:i:7:p:701-713
    DOI: 10.1016/j.healthpol.2020.05.004
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    References listed on IDEAS

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    1. Makady, A. & van Veelen, A. & de Boer, A. & Hillege, H. & Klungel, O.H. & Goettsch, W., 2019. "Implementing managed entry agreements in practice: The Dutch reality check," Health Policy, Elsevier, vol. 123(3), pages 267-274.
    2. Yasuko Inokuma, 2017. "Pharmacovigilance of Regenerative Medicine Under the Amended Pharmaceutical Affairs Act in Japan," Drug Safety, Springer, vol. 40(6), pages 475-482, June.
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    Cited by:

    1. Dabbous, Monique & Toumi, Mondher & Simoens, Steven & Wasem, Juergen & Saal, Gauri & Wang, Yitong & Osuna, José Luis Huerta & François, Clément & Annemans, Lieven & Graf von der Schulenburg, Johann-Ma, 2022. "Amortization of gene replacement therapies: A health policy analysis exploring a mechanism for mitigating budget impact of high-cost treatments," Health Policy, Elsevier, vol. 126(1), pages 49-59.

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