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