PPB - Services

Complaints, Feedback and Enquiry

Guidelines on submission of documentation for registration of Biotherapeutic products

[featured_image]
  • Version
  • Download 1512
  • File Size 644.43 KB
  • File Count 1
  • Create Date February 9, 2022
  • Last Updated June 23, 2022

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.

Attached Files

FileAction
013_HPT_PER_GUD_Guidelines_On_ Submission_Of_Documentation_For_ Registration_Of_ Biotherapeutic_Products.pdfDownload

Author

ppb_admin

Leave a comment

Your email address will not be published. Required fields are marked *