The Biological Medicines Evaluation and Research Unit (BMERU) is a sub-unit of Medicines Evaluation within the South African Health Product Regulatory Authority (SAHPRA). This sub-unit has been existing for a number of years and 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.
Biological Medicines Evaluation And Research Unit (BMERU)
Biological Medicines Variations Guidance V3
Biological Medicines Pre-Registration Consultation Meeting Guidance
Pre-Registration Consultation Meeting Material Checklist
SAHPRA – Biosimilar Medicines Guidance
Stability Testing Of Biological Medicines