Electronic-only (eCTD) submissions milestone reached
The TGA has signed an agreement to use the docuBridge software solution to receive, review and process electronic applications for the entry of prescription medicines and other therapeutic products on to the Australian Register of Therapeutic Goods (ARTG).
The regulated industry currently incurs substantial costs when they submit large volumes of paper documentation to support their applications. docuBridge will be supplied by Lorenz, a company with global experience in working with therapeutic goods regulators and pharmaceutical companies to facilitate the transition to electronic submissions.
The TGA looks forward to working with stakeholders throughout 2014 to introduce this system that will improve the quality and reduce the cost of medicines applications to the TGA.