Регуляторные исследования и экспертиза лекарственных средств (Jul 2022)

Analysis of the Main Changes in Assessment and Approval of Medicines for Human Use in the Eurasian Economic Union

  • О. G. Nefidova,
  • D. V. Babaskin,
  • A. D. Sazonov,
  • A. A. Kamaletdinova

DOI
https://doi.org/10.30895/1991-2919-2022-12-2-222-226
Journal volume & issue
Vol. 12, no. 2
pp. 222 – 226

Abstract

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The article presents a comprehensive analysis of the main changes to the Rules of marketing authorisation and assessment of medicinal products for human use in the Eurasian Economic Union (EAEU). The reflection of regulatory procedures in the legislation is quite a significant systemic feature that makes it possible to establish common requirements for the medicines present in the EAEU and to ensure the possibility of unified regulation of the matter within the national economies of the member states.

Keywords