Tag Archives: TGA
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
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
TGA Inspections are Coming – Is your Company Ready?
The TGA has recently concluded its pilot program in Pharmacovigilance inspections in Australia. Numerous companies volunteered to take part in this inspection program, and from those volunteers the TGA selected ten companies. The selection process by the TGA considered a) … Continue reading
Proposed updates to GVP Module VI and what this might mean for our clients
Good pharmacovigilance practices (GVP) are a set of measures drawn up to facilitate the performance of pharmacovigilance in the European Union (EU). GVP apply to marketing-authorisation holders, the European Medicines Agency and medicines regulatory authorities in EU Member States. The … Continue reading
Medicine labels: TGO 91 and TGO 92. What’s the impact?
Following years of consultation and review the TGA has issued two new labelling orders to replace the current Therapeutic Good Order No. 69 for specific medicine labelling requirements: Therapeutic Goods Order No. 91 – Standard for labels of prescription and … Continue reading
