The Biological Medicines is a sub-unit of Medicines Evaluation within the South African Health Product Regulatory Authority (SAHPRA). This sub-unit is primarily responsible for:
What are Biological Medicines – products that are produced from living organisms or contain components of living organisms.
Biological Medicines include a wide variety of products derived from human, animal, or microorganisms by using biotechnology.
Types of Biological Medicines include vaccines, blood, blood components, Bio therapeutics, biosimilar and recombinant proteins. Biologic products may contain proteins that control the action of other proteins and cellular processes, genes that control production of vital proteins, modified human hormones, or cells that produce substances that suppress or activate components of the immune system. Biologic drugs are sometimes referred to as biologic response modifiers because they change the manner of operation of natural biologic intracellular and cellular actions.
The South African Health Products Regulatory Authority (SAHPRA) is responsible for all vaccine lot release activities within South Africa and have contracted with the South African National Control Laboratory for Biological Products (SANCLBP) to support it in carrying out this regulatory oversight function.
The SANCLBP is a South African National Accreditation System (SANAS) ISO/IEC 17025:2017 accredited pharmaceutical testing laboratory which performs quality control tests on vaccines for human use in South Africa. The SANCLBP is also a World Health Organisation (WHO) contracted laboratory for testing prequalified vaccines and a full member of the WHO National Control Laboratory Network for Biologicals (WHO – NNB) and is committed to the current best international practice for the lot release testing of vaccines.
The SANCLBP was established in 1998 at the University of the Free State through a tender from the National Department of Health (NDoH). The mission of the SANCLBP is to ensure that all vaccines for human use meet the quality standard as registered by SAHPRA before it is released to the market.
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