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TGA announced that it has completed a process begun in 2011 (see IPQ October 22, 2011) of adopting a number of EU and ICH guidelines. Among these are ten guidelines that include ICH Q9 and Q10, in addition to other quality, stability, active substance, and clinical and non-clinical guidelines. All became effective at the end of May.
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INTERNATIONAL PHARMACEUTICAL QUALITY
Inside the Global Regulatory Dialogue
