The Australian Therapeutic Goods Administration (TGA) appears ready to proceed with a pilot program that will pave the way for full adoption of eCTD submissions. According to a timeline published by the TGA, the earliest date for finalization of specifications and eCTD implementation is early 2015.
Pilot submissions are a chance for stakeholders to assess eCTD readiness, provide feedback on specifications and implement technologies needed to compile electronic submissions. The stated intent of the TGA is to replace both paper and NeeS applications with eCTD.
TGA is now looking for suitable pilot program participants, including the following application types:
- New chemical entity
- Major variations to a prescription medicine (both with and without baseline)
- Generic medicine
For help in preparing to submit eCTD applications, industry participants can now find draft guidance documents and technical definitions on the TGA eCTD website. An introductory eCTD workshop will be held Thursday, July 3 at 9:30 a.m. in Canberra, Australia. The presentation will also be available via teleconference.
The draft TGA guidance shares many similarities with standards in Canada and Europe.
Other notable points of emphasis in the draft guidance include:
RPS – Given the desire to adopt the eCTD v4.0/Regulated Product Submissions(RPS) in the foreseeable future, the decision has been made to move to a World Wide Web Consortium (W3C) schema approach to define the new Module 1.
Study Tagging Files – The TGA does not currently have any plans to mandate study tagging files (STFs) for evaluation purposes. However, applicants wishing to reuse content submitted in other regions where STFs have been used can do so.
Electronic Signatures – The use of advanced electronic signatures e.g., digital signatures, will be crucial in achieving pure electronic communication between the pharmaceutical industry and regulatory agencies. Currently the use of digital signatures for electronic submissions is not fully supported within the TGA. Digital signatures can be used but only as an adjunct to any required written signatures.
File Reuse – Please note that the TGA is implementing a flat repository structure to make cross application referencing possible. Links to content provided in other applications simply need to be directed out of the current application structure and into the structure of the corresponding application.