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Australia Re-Releases M1 Guidance for CTD
posted by Kathie Clark @ 11:35 PM
Tuesday, January 27, 2009
In my last post, I mentioned new TGA eCTD information. TGA has also updated CTD module 1 guidance.
The TGA has released a new version of Module 1: Administrative Information and Prescribing Information For Australia, dated November 2008. Fortunately this agency includes a nice Document Change Record at the beginning of the document. Changes include:
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References to TGA organisation and titles updated
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Text amended to reflect changes in GMP clearance for prescription medicines as a result of the introduction of TGA eBusiness Services (Part B Module 1.7)
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Addition of Module 1.13 Information relating to Pharmacovigilance (Part B Module 1.13)
Module 1.13 is entirely new. It consists of a Risk Management Plan for Australia, as outlined in Chapter 1.3 of EudraLex Volume 9A – Pharmacovigilance for Medicinal Products for Human Use (version September 2008).
Hi Kathie, Agree the mandatory requirement for text searchable documents should not ordinarily be problematic if the source document is from MSWord etc..however also note that the TGA does not yet accept electronic signatures which means that such documents (eg test methods, validation reports etc.) that normally require signatures as a GLP requirement will mean that such documents will need to be OCR’d or include embedded signatures. Hopefully this will change in the near future!
Regards,
Nick Ward
Regulatory Affairs Consultant