Tag Archives: Prescription Medicines
Are you ready for the mandatory transition to eCTD for prescription medicines?
In October 2018 the TGA announced the long-awaited timelines for transition to eCTD. A staged implementation has been proposed for prescription medicines to reflect the current industry uptake of the eCTD format. The transition begins with new chemical entity, new … Continue reading
7 ways to give your Prescription Medicine Registration submission the best chance of success
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
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