Yearly Archives: 2017
New ‘SmPC’ Format for the Australian Product Information
The TGA have published a new form for providing the product information (PI) which means more work for regulatory teams but an enhancement of the quality use of medicines for Australian patients. The new form will be implemented over a … Continue reading
Posted in Regulatory Services, TGA
Tagged Regulatory Affairs, Regulatory Services, SmPC, TGA
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Transition to eCTD is gaining momentum in Australia
At the 2017 ARCS Annual Conference, the TGA announced that applications considered under the priority review pathway will be required to be submitted in eCTD format. In making this important announcement, the TGA acknowledged the clear benefits of eCTD for … Continue reading
Posted in Commercial Eyes, E-Health/Technology, Regulatory Services, TGA
Tagged eCTD, Regulatory Services, TGA
Comments Off on Transition to eCTD is gaining momentum in Australia