Opening the gateways to market and adoption of regenerative medicine? The UK case in context

Open Access Perspective article discussing current and recent trends between existing, inherited regulatory domains and standards, set against counter movements of ‘exceptionalism’ and ‘exemptionalism’.

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Jul 04, 2016
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Regenerative medicine is a site for opposing forces of gatekeeping and innovation. This applies both to regulation of market entry and to clinical adoption. Key gateways include the EU's Advanced Therapy Medicinal Products Regulation, technology assessment body NICE and commissioning/service contractor National Health Service England. The paper maps recent gatekeeping flexibilities, describing the range of gateways to market and healthcare adoption seen as alternatives to mainstream routes. The initiatives range from exemptions in pharmaceutical and ATMP regulations, through ‘adaptive pathways’ and ‘risk-based’ approaches, to special designation for promising innovation, value-based assessment and commissioner developments. Future developments are considered in the UK's ‘accelerated access review’. Caution is urged in assessing the impact of these gateway flexibilities and their market and public health implications.

Faulkner A. Opening the gateways to market and adoption of regenerative medicine? The UK case in context. Regen. Med. 11(3), 321–330 (2016).

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Regenerative Medicine

Journal, Future Science Group

Regenerative Medicine is an award-winning peer-reviewed journal, in print and web formats. The journal provides a forum to address the important challenges and advances in stem cell research and regenerative medicine, delivering this essential information in concise, clear and attractive article formats. Among other indexing services Regenerative Medicine is listed by MEDLINE/Index Medicus, EMBASE/Excerpta Medica, Chemical Abstracts, Science Citation Index Expanded™ (SciSearch®), Emcare, Biological Abstracts, BIOSIS Previews, Biotechnology Citation Index®, Journal Citation Reports/Science Edition®, Scopus® with an Impact Factor of 2.786 (2014). Each issue contains expertly drafted Reviews, Original Research articles, Perspectives, Editorials, topical insight from international leaders in their field, and additional added-value content. The Senior Editor of the journal is Professor Chris Mason, University College London. You can find out more about Regenerative Medicine at our website (www.future-science-group.com/journalprofile/regenerative-medicine/), where you can find the aims and scope of the journal and details of our international editorial board.

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