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

Research output: Chapter in Book/Report/Conference proceedingChapterScientificpeer-review

Abstract

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.
Original languageEnglish
Title of host publicationPersonalized Medicine : Legal and Ethical Challenges
EditorsJuli Mansnerus, Raimo Lahti, Amanda Blick
Number of pages17
Place of PublicationHelsinki
PublisherUniversity of Helsinki, Faculty of Law
Publication date2020
Pages145-161
ISBN (Print)978-951-51-6940-2
ISBN (Electronic)978-951-51-6941-9
DOIs
Publication statusPublished - 2020
MoE publication typeA3 Book chapter

Publication series

NameForum Iuris
Volume2342-8996
ISSN (Electronic)1456-842X

Fields of Science

  • 513 Law

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