Posted on November 30, 2018
In October 2018 the TGA announced the long-awaited timelines for transition to eCTD. A staged implementation has been proposed for prescription medicines to reflect the current industry uptake of the eCTD format. The transition begins with new chemical entity, new biological entity, biosimilar and new combination medicine applications; with a proposed implementation by first quarter 2019. The timelines for Stage 2 (other Category 1 applications) and Stage 3 (variations and other types of applications) are 1 October 2019 and 1 July 2020, respectively.
The TGA consultation on the Transition to eCTD only for prescription medicines closes on 4 December 2018 and it is an opportunity to provide feedback on how the staged transition to eCTD will impact your organisation.
The transition to eCTD may seem daunting for companies who have not “taken the plunge”, and with valid reason, as it is not a simple project. Acquiring eCTD software will require considerable planning and resource before you are up and running. Some of the key steps to consider in planning your transition include defining your publishing requirements, investigating software solutions, selecting a vendor, procuring software, preparing IT systems, installing software and training.
Full or partial outsourcing of eCTD publishing is an alternative option which can support your transition to eCTD. Outsourcing can provide a cost and time effective solution for accessing eCTD software and publishing expertise. Partial outsourcing is also an option for increasing publishing capacity and access to local publishing resources in the same time zone can assist with meeting short deadlines.