title: Problems and prospects of the circulation of biomedical cell products in the Eurasian Economic Union
metadata.name: dc.contributor.author
metadata.value: Sharkovskaya, Evgeniya A.
metadata.lang: -
metadata.name: dc.date.accessioned
metadata.value: 2021-12-16T15:52:57Z
metadata.lang: -
metadata.name: dc.date.available
metadata.value: 2021-12-16T15:52:57Z
metadata.lang: -
metadata.name: dc.date.issued
metadata.value: 2019-09
metadata.lang: -
metadata.name: dc.identifier.citation
metadata.value: Sharkovskaya, Evgeniya A. 2019. Problems and prospects of the circulation of biomedical cell products in the Eurasian Economic Union. Pravovedenie 63 (3): 429–439.
metadata.lang: en_GB
metadata.name: dc.identifier.other
metadata.value: https://doi.org/10.21638/spbu25.2019.305
metadata.lang: -
metadata.name: dc.identifier.uri
metadata.value: http://hdl.handle.net/11701/33971
metadata.lang: -
metadata.name: dc.description.abstract
metadata.value: Biomedicine has a great integration potential according to regulatory acts in the Eurasian
  Economic Union (EAEU). Moreover, one of the most relevant areas in modern biomedicine
  is regenerative personalized medicine using biomedical cell products. The article
  discusses various approaches to the legal regulation of the circulation of biomedical cellular
  products in the EAEU — a national and integration approach. As part of the study of
  the national approach, the author compares the current legislation of Armenia, Belarus,
  Kazakhstan, Kyrgyzstan, and Russia, while also identifying similar and different features.
  There is a common licensing procedure for conducting activities on the circulation of biomedical
  cell products, an increased degree of quality control, efficiency and safety, taking
  into account the ethical side of the issue, and emphasis on respect for human rights.
  The differences lie in the formal legal aspects, a heterogeneous understanding of the nature
  and content of biomedical cell products. The integration approach is illustrated by
  regulatory acts adopted at the EAEU level; their shortcomings are highlighted. Only import
  and export issues are adequately resolved from the entire life cycle of biomedical cell
  products at the EAEU level. However, there are no standards for a single market for cell
  products. For comparison, the author refers to the experience of the European Union in
  regulating the circulation of cell-based products and focuses on free movement, a centralized
  registration procedure, ethical requirements, and good clinical practice. According to
  the results of the article, the author identifies such basic problems of legal regulation as the
  lack of unification of the conceptual items, registration procedures, and procedures for applying
  to patients. Solving these problems will allow the market for biomedical cell products to
  grow rapidly and provide a qualitative breakthrough in the treatment and prevention of diseases.
  It is proposed to establish either a mechanism for verifying biomedical cellular products
  in the territory of the EAEU member countries in order to simplify registration procedures or
  create a unified registration procedure. The global goal is to develop a single standard for the
  legal regulation of the circulation of not only cellular products, but also all advanced medical
  devices in general.
metadata.lang: en_GB
metadata.name: dc.language.iso
metadata.value: ru
metadata.lang: en_GB
metadata.name: dc.publisher
metadata.value: St Petersburg State University
metadata.lang: en_GB
metadata.name: dc.relation.ispartofseries
metadata.value: Pravovedenie;Volume 63; Issue 3
metadata.lang: -
metadata.name: dc.subject
metadata.value: biomedical cell product
metadata.lang: en_GB
metadata.name: dc.subject
metadata.value: biological material
metadata.lang: en_GB
metadata.name: dc.subject
metadata.value: biomedicine
metadata.lang: en_GB
metadata.name: dc.subject
metadata.value: regenerative medicine
metadata.lang: en_GB
metadata.name: dc.subject
metadata.value: unification
metadata.lang: en_GB
metadata.name: dc.subject
metadata.value: harmonization
metadata.lang: en_GB
metadata.name: dc.subject
metadata.value: registration procedure
metadata.lang: en_GB
metadata.name: dc.subject
metadata.value: common market
metadata.lang: en_GB
metadata.name: dc.title
metadata.value: Problems and prospects of the circulation of biomedical cell products in the Eurasian Economic Union
metadata.lang: en_GB
metadata.name: dc.type
metadata.value: Article
metadata.lang: en_GB
resources.filename: 9856-Article Text-28118-1-10-20201203.pdf
resources.url: https://dspace.spbu.ru/bitstream/11701/33971/1/9856-Article%20Text-28118-1-10-20201203.pdf
resources.format: Adobe PDF
resources.size: 669,11 kB