Search results for regulatory

Complex molecules – current developments

Abstract: The pharmacological activity and toxicity of non-biological complex drugs (NBCDs) depends on their complex structure and composition. The regulatory approach leading to the registration of such drugs and their follow-on products, deemed ‘nanosimilars’, must be based on emerging scientific knowledge of NBCD properties determining their in vivo fate. Submitted: 8 April 2014; Revised: 11 […]

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Biosimilar development and regulation in Japan

Abstract: In Japan, biosimilars guidelines following the principles of the EU framework were established by Japan’s Ministry of Health, Labor and Welfare in March 2009. The guidelines cover the manufacturing process, characterization of quality attributes, and clinical and non-clinical studies for biosimilars. In this paper, the requirements for regulatory approval of biosimilars in Japan are […]

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