Category Archives: Regulatory Services
Relating to Regulatory Services of Life Sciences Industry
Commercial Eyes Recruiting: Regulatory Associate
Experience it all! Pharma, Med Device, Industry leading companies, broad range of therapeutic areas… The role… The Regulatory Associate is responsible for the preparation and submission of a range of regulatory applications for Australia and New Zealand. The … Continue reading
commercial eyes recruiting: Regulatory Services Coordinator
If you love being organised, meeting deadlines, and supporting a team to do the same..keep reading! The role… You will be a pivotal part of the team supporting regulatory consultants and associates to provide a superior client experience … Continue reading
Commercial Eyes Recruiting: Regulatory Services Associate / Consultant
Experience it all! Pharma, Med Device, Industry leading companies, broad range of therapeutic areas… The role… Operating within the Regulatory Services Business Unit this role will involve providing Regulatory Affairs and Quality consulting services to the clients of Commercial … 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
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
