Australia Re-Releases M1 Guidance for CTD

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:

  • References to TGA organisation and titles updated
  •  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)
  • 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).

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