Category Archives: Regulatory Services
Relating to Regulatory Services of Life Sciences Industry
Brexit – What’s the impact on medicines and medical devices supplied in Australia?
The long-awaited Brexit is underway with the UK exiting the EU on 31 January 2020 A transition period is now in effect until the end of 2020 with the possibility for extension. Its status quo for Australia during the transition … Continue reading
TGO 91 and TGO 92 – are your labels ready?
Following the 4-year transition period, the medicine labelling Therapeutic Goods Orders (TGOs), TGO 91 for prescription medicines and TGO 92 for non-prescription medicines, will become mandatory on 1 September 2020. Medicines that are released for supply on or after 1 September … Continue reading
Commercial Eyes appoints Simon Higgins to head up new Commercialisation Services division
Commercial Eyes Pty. Ltd., one of Australia’s most successful health technology commercialisation companies, is pleased to announce the appointment of Simon Higgins to head up it’s new Commercialisation Services division. Simon joins Commercial Eyes with over 20 years’ experience in … Continue reading
No CE mark? No problem.
Changes to legislation have increased flexibility for Sponsors looking to market medical devices in Australia. Historically the TGA has only recognised EC certificates from European notified bodies or a TGA conformity assessment to support the inclusion of a Medical Device … Continue reading
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
Making the most of complementary medicines reforms
In March this year the TGA finally started rolling out the long awaited Complementary Medicine Reforms. One of the most significant changes for sponsors of listed complementary medicines is the abolition of the “free text” box for indications. All … Continue reading
What is Happening with the Provisional Approval Pathway?
We’ve come a long way When the independent review of medicines and medical devices regulation was announced in October 2014, the pharmaceutical sector immediately saw the opportunity for an expediated approval pathway for certain prescription medicines. A provisional approval pathway would allow … Continue reading
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
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
Stressed? Well your products should be!
Treating your drug substance or drug product with an acid, a base, an oxidising substance, heat or exposing it to direct light might sound extreme, but that is exactly what the TGA want to see in your registration dossier. Assay … Continue reading
