28 November 2019
The nanomedicine working group is a cross-functional collaborative designed to support Australia in defining a regulatory pathway for nanomedicines and their follow-on products, nanosimilars. The focus of the group will include approval and post approval standards and its implications for research, payers, prescribers and patients.
Demand for regulatory clarification and consistency has been driven by the increase in new technology and the anticipation of follow-on products (nanosimilars) entering the market. Numerous publications have stressed the need for global harmonisation and consistency with respect to regulation, yet no regulatory body has yet taken the lead. Given the global harmonisation and increased work-sharing there is an important leadership role for the nanomedicines working group – both from an Australia TGA perspective but also with the EMA and the FDA.
To express an interest in joining, please contact Dr Julie-Anne White on jwhite@biomelbourne.org by 16 December 2019.
