Communique of GTTAC Meeting of 6 June 2016
This Communiqué covers matters considered at the 49th meeting of the Gene Technology Technical Advisory Committee (6 June 2016).
Clinical Network Services (CNS) Pty Ltd is seeking approval to conduct clinical trials to assess the safety and tolerability of a new type of GM influenza (flu) vaccine. The trials would involve administration of the GM flu vaccine to up to 500 healthy adult male volunteers over a period of five years.
GTTAC noted the key points in the RARMP, including that the risk assessment concludes that the proposed dealings with the GMO pose negligible to low risks to the health and safety of people and the environment. GTTAC also noted that the trials must meet the Therapeutic Goods Administration requirements and would require approval from a human research ethics committee at each trial site. GTTAC discussed a number of topics which are captured in the committee’s advice to the Regulator within.