Over Ten Years Since the Adoption of the EU Regulation on Advanced Therapy Medical Products - Lessons Learned Thus Far

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Sammanfattning

Advanced therapy medicinal products (‘ATMPs’) are a heterogeneous class of modern biotechnology medicines encompassing medicinal products based on genes, cells, and tissues. The European Medicines Agency (the ‘EMA’) and the European Commission issued a joint action plan in late 2017 with the goal of improving the regulatory environment for ATMPs to facilitate the research, development, and approval of these products in the European Union. Regulators around the world are taking measures to create a facilitative regulatory environment that encourages innovation, protects public health, and enables timely patient access to innovative, new therapies whilst ensuring patient safety. In Europe, the role of risk-proportionate adaptations to clinical trials and GMP manufacture along with the EMA’s early-access incentives and initiatives are presented as potential facilitators of market entry.
Originalspråkengelska
Titel på värdpublikationPersonalized Medicine : Legal and Ethical Challenges
RedaktörerJuli Mansnerus, Raimo Lahti, Amanda Blick
Antal sidor17
UtgivningsortHelsinki
FörlagUniversity of Helsinki, Faculty of Law
Utgivningsdatum2020
Sidor145-161
ISBN (tryckt)978-951-51-6940-2
ISBN (elektroniskt)978-951-51-6941-9
DOI
StatusPublicerad - 2020
MoE-publikationstypA3 Del av bok eller annan forskningsbok

Publikationsserier

NamnForum Iuris
Volym2342-8996
ISSN (elektroniskt)1456-842X

Vetenskapsgrenar

  • 513 Juridik

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