FDAnews Drug Daily Bulletin
Pharmaceuticals / Quality / Regulatory Affairs / GMPs / Postmarket Safety / Research and Development

TGA Updates Guidelines for Transmissible Spongiform Encephalopathies

April 3, 2014

Australia’s Therapeutic Goods Administration has updated its guidance on minimizing the risk of transmissible spongiform encephalopathies, bringing it in line with changes made by the World Organisation of Animal Health.

The TGA first published guidance on minimizing the risk of TSE in therapeutic goods that contain tissue from animals susceptible to the TSE family of diseases in 2004. The updated version, published Wednesday, requires marketing authorization applications to:

  • Acknowledge the European Pharmacopoeia as Australia’s default standard for minimizing TSE risk;
  • Assess TSE risk of all products containing material from humans or ruminants before they are allowed to circulate in Australia;
  • Ensure that all materials from ruminants such as cattle, sheep, goats and deer are sourced from countries whose TSE risk is as low as possible;
  • Certify that all materials come from animals “fit for human consumption”;
  • Certify that all products are from the lowest-possible tissues; and
  • Consider the manufacturing processes for ingredients derived from ruminants.

The guidance also requires that sources of human-derived materials not carry any genetic, environmental or iatrogenic risk of prion disease. That disqualifies patients who lived in or visited England, Scotland, Wales, Northern Ireland or the Isle of Man between Jan. 1, 1980, and Dec. 31, 1996, or received blood products there since Jan. 1, 1980.

The FDA updated its TSE risk avoidance guidance in January, requiring manufacturers using animal products to document steps taken to ensure the absence of the disease, including animal donor vaccinations.

The updated TGA guidelines can be found at www.fdanews.com/ext/resources/files/04/04-03-14-TGATSE.pdf. — Lena Freund

Subscribe to Drug Industry Daily for complete coverage of the pharmaceutical industry. Click here for more information.