Supplementary requirements for therapeutic goods for minimising the risk of transmitting transmissible spongiform encephalopathies (TSEs)
December 2004
This document, dated December 2004, is TGA guidance on the management of TSE risks associated with putatively "low-risk" ingredients currently listed in Category C of the EMEA Guideline Note for Guidance on Minimising the Risk of Transmitting Animal Spongiform Encephalopathy Agents via Human and Veterinary Medicinal Products (EMEA/410/01 rev 2, October 2003).
The EMEA Guidelines still represent the main TGA strategy for managing TSE risks associated with all other materials of animal origin.
The TGA policy on "low-risk" ingredients has been through several formal rounds of consultation with industry, in January and July 2002, and February 2003. The final version of the document was released to the four peak industry associations on 20 November 2002 and after revisions was implemented on June 2003. This document includes minor revisions to the Supplementary Guideline dated June 5, 2003, taking into account revisions to the EMEA 410/01 rev 2.
The document outlines a self-assessment process whereby sponsors of therapeutic goods can collate information necessary to certify compliance with the TGA requirements to minimise TSE transmission risks. Self-certification can be advised at the time of submission of a new application to include a product on the ARTG, or for variation of an existing ARTG entry, or as part of a TGA review program.
Since the scientific knowledge about TSE transmission and risk materials is constantly evolving, it is intended that the document be a "living document". Changes to the policy will be made as relevant new information about TSE risk management comes to light.
Larry Kelly PhD
Ag/Director TGA Laboratories
December 2004
- Supplementary requirements for therapeutic goods for minimising the risk of transmitting Transmissible Spongiform Encephalopathies (TSEs) (pdf,115kb)
- Note for Guidance on Minimising the Risk of Transmitting Animal Spongiform Encephalopathy Agents via Human and Veterinary Medicinal Products (EMEA/410/01 rev 2, October 2003) (pdf,210kb)
Contents
- Purpose and scope
- Introduction
- Background
- Literature review
- Pharmacopoeial monographs and guidelines
- Assessment of ingredients of concern
- 6.1 Milk and materials derived only from milk
- 6.2 Gelatin and collagen
- 6.3 Wool derivatives
- 6.4 Lecithin (phosphatidyl choline, phosphatidyl serine and phospholipids)
- 6.5 Amino acids and hydrolysed proteins
- 6.6 Glycerol, stearates and other tallow derivatives
- 6.7 Other low-risk materials
- Reliance on EDQM certificates
- Quality systems
- Bibliography
- Appendices
- Appendix 1 Risk categories of ruminant tissues and fluids
- Appendix 2 Evaluation flow chart for self-assessment by industry
- Appendix 3 Country list