Epidemiological situationsCompliance to Therapeutic Goods Order No. 88 - Table 1 (s)

Rebecca Newton PhDHead Blood and Infectious Disease Safety UnitBiological Science Section, Scientific Evaluation Branch, TGABiotherapeutics Association of Australasia 2016 AGM, TGA Workshop & Education Session

13 October 2016

Epidemiological situations

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)

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Epidemiological situations

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)

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4Epidemiological situations

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

5Epidemiological situations

Managing epidemiological situationsTGA 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