Australian Regulatory Guidelines

In June 2004 the Australian Regulatory Guidelines for Prescription Medicines (ARGPM) were issued by the TGA to replace the AGRDl. Under the ARGPM the format for registration applications in Australia is the Common Technical Document (CTD) developed through the International Conference on Harmonisation (ICH). 

The mouse micronucleus test has been agreed with the Australian regulatory authorities as an alternative to the dominant lethal assay suggested in the official guidelines. 

Only the Pharmacopoeias (for example the US Pharmacopoeia (1995) and the British Pharmacopoeia (1998)), and the Australian Regulatory Authority have been sufficiently worried by instrumental factors to give written requirements for instrument performance. Whilst these guidelines are not entirely consistent at least they are attempting to ensure consistency of calibration practices between laboratories. 

As described earlier in this chapter, the requirements of Medsafe are closely aligned with the policies and guidelines published by the EU and CPMP, although it also accepts guidelines published by other regulatory bodies, such as the ICH, US FDA and Australian TGA. 

In 1996 and 1997 the International Conference on Harmonization (ICH) published guidelines for analytical method validation [18]. These documents present a discussion of the characteristics for consideration during the validation of the analytical procedures included as part of registration applications submitted within the European Union, Japan, and the United States. Regulatory agencies have emitted documents, largely inspired by ICH documents. It is the case of the FDA [19, 20], the European Medicines Agency (EMA) [21,24], and the Australian Pesticides and Veterinary Medicines Authority [25], to name just a few. 

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