Role of the ACCM in the TGA’s regulatory decision making process
The ACCM is a statutory advisory committee established by the Therapeutic Goods Regulations 1990.
The TGA currently has seven 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 ACCM provides advice to the TGA on, amongst other things, matters relating to the inclusion, variation or retention of complementary medicines on the Australian Register of Therapeutic Goods.
The advice provided by the ACCM 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 1989. 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 some time 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 matters referred for advice
The committee was asked to advise and comment on how sponsors of generic medicine products for oral administration containing iron polymer complexes might demonstrate equivalence of their medicine to an innovator reference medicine.
The advice has now been provided for consideration as part of the TGA's regulatory decision-making process.
Further information
Meeting statements are made publicly available after each meeting.
For further information on the ACCM, please visit the ACCM web page or contact the ACCM Secretary by phone on (02) 6289 2305 or email: accm@health.gov.au.