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Presentation: Epidemiological situations: Therapeutic Goods Order No. 88 - Table 1 (s)

TGA presentations: Biotherapeutics Association of Australasia 2016 AGM, TGA Workshop & Education Session

1 November 2016

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Presentation

  • Presented by: Rebecca Newton, Biological Science Section, Scientific Evaluation Branch, Therapeutic Goods Administration
  • Presented at: Biotherapeutics Association of Australasia 2016 AGM, TGA Workshop & Education Session, Canberra
  • Presentation date: 13 October 2016
  • Presentation summary: Managing epidemiological situations in accordance with Therapeutic Goods Order No. 88 - Standards for donor selection, testing and minimising infectious disease transmission via therapeutic goods that are human blood and blood components, human tissues and human cellular therapy products, Table 1 (s). The Zika virus outbreak is provided as an example.

Transcript

Epidemiological situations: Compliance to Therapeutic Goods Order - No. 88 - Table 1 (s)

Rebecca Newton PhD
Head Blood and Infectious Disease Safety Unit
Biological Science Section, Scientific Evaluation Branch, TGA

Biotherapeutics Association of Australasia 2016 AGM, TGA Workshop & Education Session, 13 October 2016

Slide 1 - Managing epidemiological situations

  • Therapeutic Goods Order No. 88 Standards for donor selection, testing and minimising infectious disease transmission via therapeutic goods that are human blood and blood components, human tissues and human cellular therapy products
  • Table 1 (s) requires that 'A donor with exposure to particular epidemiological situations' is subject to a deferral period 'consistent with the epidemiological situation'
  • 'Deferral procedures and parameters for particular epidemiological situations should be informed' to the TGA
  • This criterion is intended to cover unforseen infectious disease risks in donors:
    • Domestic disease outbreaks (e.g. Dengue)
    • International disease outbreaks (e.g. Zika, Ebola)

Slide 2 - Managing epidemiological situations

  • It is the responsibility of the sponsor to demonstrate that processes are in place to identify, monitor, assess and action epidemiological situations relevant to their products.
    • Process for monitoring for relevant infectious disease outbreaks (domestically and internationally
    • Risk assessment that identifies whether an infectious disease outbreak is relevant to the quality (infectious disease safety) of the cells/tissue
    • Process to link monitoring information to any action taken (e.g. interim instruction/permanent deferral)

Slide 3 - Managing epidemiological situations

  • TGA is supportive of centralised procedures for monitoring and initially assessing relevant infectious disease outbreaks.
  • These are being developed by BAA and EBAANZ, using resources provided by the ARCBS
  • TGA is providing input into the procedural documents
  • Tissue banks that want to utilise these procedures (once finalised) will be required to submit a variation to their included biological
  • Implementation of the procedures and any donor deferrals would not require a variation, but do need to be informed to the TGA

Slide 4 - Managing epidemiological situations

TGA experience with Zika virus outbreak

  • Not all tissue banks informed TGA of whether or not deferrals were implemented for Zika virus
  • Some banks have provided updates to their deferrals as new evidence/changes to FDA guidance became available
  • TGA would like each sponsor of biologicals to notify of their actions (including no action)
    • To see how procedures for epidemiological situations are being implemented by each sponsor
    • To ensure consistency in approach for the same cell/tissue types

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