The TGA have released a final specification for Australian eCTD submissions today.
Last year the TGA announced their chosen eCTD review tool vendor as LORENZ docuBridge, implemented a pilot program, held industry presentations and provided feedback from consultation. Now the final specification, version 3.0 has been released.
This is an important milestone for Australia in moving forward to fully electronic submissions. There is a lot of local regulatory associates to learn and the Australian regulatory affairs landscape provides publishing challenges different to those experienced in other regions.
Many Australian affiliates are in the beginning stages of implementation whereas their global counterparts have had many years experience and the necessary infrastructure to support eCTD publishing.
There are many questions that Australian companies & branches should be considering in the transition to eCTD. Education via conferences and/or outsourced training will be a must.
Pharma To Market will be attending the ARCS Scientific Congress in Sydney on May 6 – 7, speaking at the eCTD session and answering your questions one-on-one at our sponsored coffee cart. Chat with a Pharma To Market representative to find out how we can help you transition to eCTD submissions.