Guidelines on submission of documentation for registration of Biotherapeutic products

The guidelines apply, in principle, to all biologically active protein products, which are used in the treatment of human diseases including those prepared by recombinant DNA technology using prokaryotic or eukaryotic cells. The guidelines also apply to protein products used for in vivo diagnosis (e.g. monoclonal antibody products used for imaging), products used for ex-vivo treatment, and those intentionally modified by, for example, PEGylation, conjugation with a cytotoxic drug, or modification of rDNA sequences. Some aspects of these guidelines may apply to products produced in transgenic animals and plants. However, specific issues for such products can be found in the relevant documents published by WHO and Pharmacy and Poisons Board should be consulted for specific advice on these products.

Whole blood, cellular blood components and Protein products used for in vitro diagnosis are not within the scope of these guidelines.