Regulatory requirements for the development and registration of biosimilars in South Africa

Author(s): Khamusi Philip Mutoti, BSc, BPharm Sci, Professor Nontombe Mbelle, MChB, MMed, FC Path (CMSA), Henry MJ Leng, PhD

Abstract: In South Africa, medicines are registered and regulated in terms of the Medicines and Related Substances Control Act (Act 101 of 1965), as amended, and the regulations to this Act. A guideline which outlines the quality, non-clinical and clinical requirements for the registration of a biosimilar medicine was first published in March 2012. This […]

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