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ACSOV meeting statement, Meeting 1, 13 March 2013

Advisory Committee on the Safety of Vaccines

13 March 2013

Role of the Advisory Committee on the Safety of Vaccines (ACSOV) in the TGA's regulatory decision making process

The ACSOV is a statutory advisory committee established by the Therapeutic Goods Regulations 1990.

The TGA currently has nine statutory advisory committees from which it can obtain independent expert advice on specific scientific and technical matters to aid the TGA's regulatory decision making and other regulatory processes.

The ACSOV provides advice to the TGA and the Office of Health Protection (OHP) on, amongst other things, matters relating to the safety, risk assessment and risk management of vaccines supplied in Australia.

The advice provided by the ACSOV is an important element in the undertaking of the regulatory functions of the TGA. However, it forms only part of the information that is available to, for instance, a TGA delegate making a regulatory decision under the Therapeutic Goods Act. While appropriate consideration will be given to such advice, it is important to note that neither the TGA nor a TGA delegate is obliged to follow it.

It should also be noted that information about advice provided by the committee may not become publicly available for sometime after a committee has provided that advice. The purpose of this Meeting Statement is to describe in general terms the matters considered by the committee at each meeting and for it to be available as soon as reasonably practical after the relevant meeting.

Overview of the safety reviews referred for advice

The committee was provided with an overview of how vaccine surveillance is undertaken and an overview of the signal detection and investigation processes. The committee was also provided with an update on the status of three current vaccine surveillance projects being undertaken by the TGA and OHP and asked to comment on these projects.

Other matters considered

Members were provided with an overview of the TGA's regulatory processes with respect to the registration and subsequent post market monitoring of vaccines.

The committee was also provided with an overview of Risk Management Plans (RMPs). A RMP is a set of pharmacovigilance activities and interventions designed to identify, characterise and manage risks relating to a medicine or vaccine. The RMP forms an integral part of an application to register a new vaccine in Australia or an application to change the marketing approval of a vaccine (for example when there is a significant change in indication).

Next meeting

The next meeting of the ACSOV is scheduled for 24 May 2013.

Further information

Meeting statements are made publicly available after each meeting. For further information on the ACSOV, please visit the ACSOV web page or contact the ACSOV Secretary: Dr Katherine Gray by phone on 02 6232 8583 or email: