Category Archives: Regulatory Services
Relating to Regulatory Services of Life Sciences Industry
Senior Consultant, Regulatory, Quality & Compliance
The Company Commercial Eyes is Australia’s leading Pharmaceutical and Medical Device commercialisation consultancy offering pre and post market advice and support to local and international companies operating in Australia & New Zealand. We provide a full suite of services through … Continue reading
Commercial Eyes Recruiting: Senior Manager, Regulatory, Quality & Compliance
The Company Commercial Eyes is Australia’s foremost Pharmaceutical and Medical Device commercialisation consultancy offering pre and post market advice and support to local and international companies operating in Australia & NZ. What we do – and the consistent excellence with … Continue reading
Coronavirus (COVID-19): Information on medicines and medical devices supply in Australia
The Therapeutic Goods Administration (TGA) has consolidated all the COVID‑19 information on their website to assist manufacturers and suppliers with accessing the latest information about the special regulatory requirements for the supply of medicines and devices (including exemptions) in Australia … Continue reading
Improved Consumer Medicine Information template
The TGA have now released implementation dates for the updated Consumer Medicine Information (CMI) template that was developed throughout 2019 to reduce complexity and improve readability. Newly registered medicines must use the new template from 1 January 2021, while previously … Continue reading
Hand sanitiser – What do you need to know to supply in Australia?
The COVID-19 pandemic has seen the TGA rapidly changing the regulatory landscape for in-demand products that can help reduce the spread of the virus. Given all the changes taking place, it can be difficult to ascertain exactly how product categories … Continue reading
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
