The Biological Medicines is a sub-unit of Medicines Evaluation within Pharmaceutical Evaluation Management of the South African Health Product Regulatory Authority (SAHPRA).
This sub-unit is primarily responsible for:
- Evaluation of applications for registration of biological medicines
- Evaluation of applications for amendments to registered biological medicines
- Vaccine Lot Releases
- Other activities include communication with the pharmaceutical industry on policy matters affecting the registration and use of biological medicines, policy development and optimisation of the registration processes.
- Establishment/development of framework for regulation blood and blood products and stem cells and cell based therapy following the pronouncement of blood and blood components on the list of essential medicines.
Definitions of Biological Medicines
What are biological medicines?
These are products that are produced from living organisms or contain components of living organisms – this includes a variety of biological medicines derived from human, animal, or microorganisms by using biotechnology.
What are the types of biological medicines?
The many types includes: 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.
Blood & Blood Products
- Blood, blood components, blood bank devices, blood donor screening tests
- Blood products e.g. for the treatment of haemophilia
Hormones
- Hormones for hormone deficiencies e.g. insulin for diabetes and growth hormone for growth hormone disorders.
Monoclonal antibodies
- Monoclonal antibodies for the treatment of autoimmune diseases and cancers.
Immunomodulators
- Immunomodulators e.g. beta-interferon for multiple sclerosis.
Vaccines
- Vaccines for use in children and adults, and tuberculin testing.
- Vaccines can prevent a number of diseases.
Biosimilars
- These are biological products that are very similar to a reference biologic and for which there are no clinically meaningful differences in terms of safety, purity, and potency.
Enzymes
- Enzymes e.g. to remove blood clots.
Vaccine Lot Release
SAHPRA, through the Biological Medicines Unit within PEM, is responsible for all vaccines 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.
- Vaccines are used in healthy populations and thus, safe and effective vaccines are essential public health tools that are strictly regulated internationally. This ensures that the vaccines are manufactured according to the required prerequisites and specifications of registration before they can be placed on the market.
- Vaccine lot release activities, as conducted by the SANCLBP, are part of the regulatory process of vaccines and involve the independent evaluation of each vaccine lot before it is released onto market. All vaccines registered by SAHPRA or authorised under Section 21 are subject to lot release by SAHPRA. Vaccine lots will be released for public use only if they conform to the required specifications.