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Regenerative medicine regulatory policies: A systematic review and international comparison


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


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

    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. Hampson, G. & Towse, A. & Dreitlein, B. & Henshall, C. & Pearson, S., 2018. "Real World Evidence for Coverage Decisions: Opportunities and Challenges," Research Papers 001997, Office of Health Economics.
    3. 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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