The Biologicals Unit is part of the Licensing Division of the MHRA, and is responsible for the assessment of the full range of applications for biological and biotechnology products.
The Unit consists of pharmacists and biochemists who assess the 'quality' , that is manufacture and formulation of the product, a toxicologist for the pre-clinical data and physicians to assess the clinical data.
The Unit also provides the professional secretariat for the Biologicals Subcommittee of the Commission on Human Medicines.
What is a biotechnology product?
A biotechnology product is one manufactured by recombinant DNA technology, one where genetic manipulation of cells is required, or a monoclonal antibody. Applications for these products are required to be submitted through the European Centralised procedure (European Medicines Agency website). They comprise List A (the mandatory part) of the procedure.
The UK bids for rapporteurships for these products and is a leader in the field.
What is a biological product?
Biological products are defined as so because they are more difficult to characterise or control than standard chemically synthesised pharmaceuticals.
They include those where the starting material may be human or animal tissue or of microbiological origin. Also included are those where a complex bioassay system is required to monitor potency.
The two largest groups of biologicals are blood products and vaccines. Other products include hormones, larger peptides and a miscellaneous group of tissue derived products.
Contact for further information
For further information on this part of our site, please contact our Biologicals Unit, 151 Buckingham Palace Road, London SW1W 9SZ, telephone 020 3080 6296 or email info@mhra.gsi.gov.uk
