BIOLOGICAL PRODUCTS UNIT

Advances in cell culture or recombinant DNA or hybridoma techniques have encouraged the design and development of a host of macromolecular-based therapy products called biological products. They may be composed of nucleic acids, or proteins or sugar molecules or complex combinations of these macromolecules. Living entities, such as cells or tissues may be classified as a biologic. Unlike chemically synthesized medicines, biological products are derived from living organisms (ranging from normal or genetically modified microorganisms to fluids, tissues and cells derived from various animals and human sources) by the application of biotechnology methods and other cutting-edge technologies.

In response to the current trends in human and veterinary medicine, the Food and Drugs Authority (FDA) established the Biological Products Unit (BPU) to support the core mandate of the Authority, protecting public health and safety. The unit is dedicated to promoting public health through assuring the quality, safety, and efficacy of biologics and related products (such as vaccines, blood and blood products, cellular therapy products, and gene therapy products) used in the treatment and prevention diseases.

The mandate of BPU is supported by two (2) specialized operational sections; biopharmaceuticals/biologics, and whole blood and blood components. In Ghana, biological products include, but are not limited, to the following:

Vaccines; use in children and adults. Vaccines are broadly divided into three (3) groups.

  • Viral formulations, contains an active immunizing agent for a virus (e.g., Influenza, Yellow Fever (Stamril), Rabies, Rotavirus, Measles, Mumps, Rubella, Hepatitis A (Havrix), and Hepatitis B (Genevac B), Human Papillomavirus (Gardasil), Polio, etc.
  • Bacterial formulation, contains an active immunizing agent for a bacterial (e.g., Pneumoniae, Tetanus, Diphtheria, Pertussis, Typhoid fever, Escherichia coli, Meningitis (Mencevax ACWY), Haemophilus Influenzae type b (Hiberix), Streptococcus pneumonia serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Synflorix®)  and Tuberculosis
  • Combination, contain active immunizing agents for multiple virus and/or bacteria (e.g., DPT-IPV – Diphtheria-Pertussis-Tetanus-Polio (Inactivated), MMR – Measles-Mumps-Rubella (Priorix), Haemophilus Influenzae type b – Tetanus Toxoid (Hiberix)

 

Biotechnology-derived therapeutic proteins; new generation of therapeutics that hold promise for providing novel treatments for disease for which no other treatments are available (e.g., Monoclonal antibodies, Cytokines (interferons, interleukins, colony-stimulating factors, tumour necrosis factors), Growth factors, Hormones, Enzymes, etc.)

Biosimilars or Follow-on Biologics or Subsequent Entry Biologics; biologic that is highly similar to another biological medicinal product (reference product) that has already been registered for use in Ghana (e.g., Genotropin (reference product) and Omnitrope (Biosimilar))

Plasma-derived medicinal products; therapeutic protein products with the drug substance extracted from human blood plasma
(e.g., tissue Plasminogen Activator, human coagulation factors (VII, VIII, IX, XI), human fibrinogen, activated protein C, Intravenous Immunoglobulin (IVIG), etc.)

Cellular therapy products; autologous, allogeneic or xenogeneic cells that have been propagated, expanded, selected, pharmacologically treated or otherwise altered biological characteristics ex vivo that is administered to humans and applicable to the prevention, treatment, cure, diagnosis or mitigation of disease or injuries
(e.g., Stem cells and Stem cell-derived products (Hematopoietic, Mesenchymal, Embryonic, Umbilical cord blood, etc.), Cancer vaccines and immunotherapies (Dendritic cells, activated T lymphocytes, B lymphocytes, monocytes, Cancer cells chemically modified or unmodified, Pancreatic islets, Chondrocytes, Keratinocytes, Hepatocytes

Urine- or tissue-derived medicinal products; therapeutic product with the drug substance obtained from human urine or tissues
(e.g., Urokinase, Bone, Skin, Corneas, Ligaments, Tendons, Dura Mater, Heart Valves, Hematopoietic Stem/Progenitor cells derived from peripheral and cord blood, oocytes, semen, etc.)

Gene therapy products: therapeutic product that introduces a genetic material into a person’s DNA to replace a mutated or deleted coding region
(e.g., viral vectors)

Low Molecular Weight Heparins (LMWH); class of anticoagulant used remedy episodes that feature thrombosis(e.g., Dalteparin/Fragmin, Enoxaparin/Clexane, Nadroparin/Fraxiparine)

Blood and blood components; Blood refers to whole blood extracted from human donors. Blood components are therapeutic components that have been derived from whole blood. The standards of quality and safety for the collection, testing, processing, storage, matching and distribution of human blood and blood components must be assured. (e.g., Red cells, White cells, Progenitor cells, Platelets, Plasma, etc.)

 

REGISTRATION APPLICATION FORM FOR VACCINES click for more

REGISTRATION RENEWAL APPLICATION FORM FOR VACCINES click for more

GUIDANCE DOCUMENTS FOR REGISTRATION APPLICATION click for more

BATCH RELEASE TEMPLATE FOR SELECTED VACCINES click for more

REGISTRATION APPLICATION FORMS click for more

APPLICATION FOR REGISTRATION OF BIOSIMILARS click for more

APPLICATION FOR REGISTRATION OF BIOLOGICAL PRODUCTS click for more

CURRENT BIOLOGICAL PRODUCT REGISTER click for more

See Also

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