Monthly Archives: September 2010
TGA Reforms: The Verdict
The Therapeutic Goods Administration (TGA) will on 1 November officially commence operating according to the new Streamlined Submission Process for Prescription Medicines. We assess the likely long-term impact on market access in Australia. Continue reading
Posted in Regulatory Services, TGA
Tagged Evaluation Process, Prescription Medicines
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The Top 5 – Tips on the TGA’s Streamlined Evaluation Process
This month’s Top 5 looks at how to help your regulatory affairs team deal with the TGA’s new Streamlined Evaluation Process for Prescription Medicines. Continue reading
Posted in Regulatory Services, TGA
Tagged Evaluation Process, Prescription Medicines, Top 5
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It’s Out to Work We Go
Globalisation and its attendant pressures means pharma is experiencing a rapid rise in outsourcing. Continue reading
You Will Comply!
Eye Spy looks at the highlights of the Pharmaceutical Benefits Branch’s recent report on the role compliance plays in health outcomes. Continue reading