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. 2018 May 28;5:158. doi: 10.3389/fmed.2018.00158

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Copyright © 2018 Rousseau, Mačiulaitis, Śladowski and Narayanan.

This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

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Regulatory pathways for ATMPs in Europe. The usual sequence in which procedures are requested by applicants. Note that all procedures can be requested at any time during development. ATMP, Advanced Therapy Medicinal Product; CAT, Committee for Advanced Therapies; EMA, European Medicines Agency; FDA, Food and Drug Administration; HTA, Health Technology Assessment body; PRIME, Priority medicine procedures; SME, Small and Medium-sized Enterprise. [Adapted from Maciulaitis et al. (2), (15)].