TGA signs agreement for eCTD submissions
The TGA has announced that it has signed an agreement to use the docuBridge® software solution to receive, review and process electronic applications (eCTD submissions) for the entry of prescription medicines and other therapeutic products on to the Australian Register of Therapeutic Goods (ARTG).
This has occurred as a result of a tender process for software and services to assist the TGA in processing electronically the large amount of data for prescription medicine dossiers (category 1 and 2) currently received in paper format which is costly to produce, handle and store.
The intent is to provide the TGA with the capability to use the ICH electronic Common Technical Document (eCTD) review tool so that the TGA will be able to accept dossiers submitted solely as electronic eCTDs.
The docuBridge® platform will be supplied by Lorenz, a company with global experience in working with therapeutic goods regulators and pharmaceutical companies to facilitate the transition to eCTD submissions.
The TGA has stated that it 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.
In relation to medical devices, the International Medical Device Regulators’ Forum (IMDRF) has released drafts of a modular Table of Content (ToC) for device applications, both for IVD and non-IVD medical devices.
This comes from the IMDRF work item on a Regulated Product Submission (RPS). RPS is a message standard that can be used for the eCTD submission of product information between a company and a regulatory agency for the purpose of gaining market authorization. The message standard (envelop) is independent of submission content. The project is composed of two complementary components:
- Beta testing of the RPS Standard to confirm it is fit for purpose for medical devices; and
- Developing a common, modular Table of Content (ToC) for device applications (IVD and non-IVD).
The development of RPS is being undertaken through HL7, an ANSI accredited Standards Development Organization.
The project is seen as an important step towards the ultimate goal of common premarket requirements for device applications.
