The basic requirements for the regulatory oversight of quality control of biological medicines

  • N. A. Vetiutneva National Medical Academy of Post-Graduate Education named after P. L. Shupyk, Kyiv
  • O. P. Shukaeva National Medical Academy of Post-Graduate Education named after P. L. Shupyk, Kyiv
Keywords: biological drugs, the legal documentation

Abstract

The legal documentation and legal frameworks that control the regulation of the quality of biological medical products were studied. Biological products are highly tissue specific and bioavailability, which determines: a wide range of possibilities in the treatment of severe disease at any age and the future development of this segment on the global pharmaceutical market. The specificity of this group of drugs pertains the procedures of quality assurance and regulatory oversight at all stages of the life cycle of products.

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Published
2019-02-12
How to Cite
Vetiutneva, N. A., & Shukaeva, O. P. (2019). The basic requirements for the regulatory oversight of quality control of biological medicines. Farmatsevtychnyi Zhurnal, (3), 3-8. Retrieved from https://pharmj.org.ua/index.php/journal/article/view/394