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Insights

Regulatory Announcements

Medsafe NZ has been working on a new therapeutic products regulatory regime to replace and modernise the regulatory arrangements for medicines.

MEDSAFE NZ Moves Ahead in 2020

Regulatory Announcements24 Feb 2020

Since 2015, Medsafe NZ, the New Zealand Medicines and Medical Devices Safety Authority, has been working on a new therapeutic products regulatory regime to replace and modernise the regulatory arrangements for...

The Federal Court imposes $10 million penalty for the alleged Peptide Clinics advertising breaches. Peptide Clinics Pty Ltd was liquidated earlier this year.

Consumer Insecurity / Vanity Targeted by TGA – Massive Fines

Regulatory Announcements31 Jul 2019

The appearance of misleading terms and claims on websites and social media has attracted the attention of the TGA. The Therapeutic Goods Administration in Australia (TGA) has advised that fines were...

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News Releases

Concept of teamwork: Close-Up of hands business team showing unity with putting their hands together.

The Adjutor Healthcare Group and Axis Health Co Announce a Strategic Partnership to Drive Client Success

News Releases19 Jun 2024

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The Adjutor Healthcare Group Expands Global Presence with the Establishment of Adjutor Healthcare Hong Kong

News Releases08 Feb 2024

Today marks a significant milestone for the Adjutor Healthcare Group, as we proudly announce the establishment of Adjutor Healthcare Hong Kong, further solidifying our commitment to excellence supporting global healthcare, development,...

Adjutor Healthcare announces launch of Adjutor Healthcare New Zealand Limited consulting and sponsorship entity for medicines and medical devices.

Launch of Adjutor Healthcare (NZ) Limited

News Releases13 Feb 2020

This is a very exciting day for me, a Kiwi living and working in Australia. Today, we officially launched our New Zealand entity Adjutor Healthcare (NZ) Limited. The mission of Adjutor...

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Blog Posts

Medical Device Registration in Australia

Blog Posts19 Jul 2024

Registering a medical device in Australia is a complex but crucial process that ensures the safety and performance of devices entering the healthcare market. Navigating the regulatory landscape of the Therapeutic...

How to Register a Medicine in Australia

Blog Posts28 Jun 2024

Navigating the complexities of product development, clinical development, regulatory services for product registration/ lifecycle management, quality/QMS, training and commercialisation requires a tailored approach that balances local requirements and global...

Enter the Dragon: Navigating Hong Kong’s Medicines Regulatory System in 2024

Blog Posts08 Feb 2024

The Year of the Dragon stands as a fitting emblem for Hong Kong’s medicines regulatory system, symbolising strength, resilience, and vigilant...

Personalised Medical Devices, along with four new sub-categories, now replace the former Custom-made Medical Devices regulation.

Custom-made Medical Devices in Australia: Now it’s Personal(ised)

Blog Posts05 Mar 2021

Recent changes in TGA Medical Device Regulations In December 2020, TGA released a new Personalised Medical Device Guideline along with a suite of new names and definitions that have shaken up...

Artificial Intelligence Regulation. AI poses ethical, legal, and socio-economic dilemmas such as data sensitivity, privacy, and cyber security.

Is Artificial Intelligence Becoming Too Smart for Regulators?

Blog Posts28 Jan 2021

Is Artificial Intelligence Becoming Too Smart for Regulators? AI is Everywhere and it isn’t that New! The term ‘artificial intelligence’ (AI) was first coined in the 1950s. Since then, this disruptive...

Despite the postponement of the EU Medical Devices Regulation implementation to May 2021 appearing to offer breathing room, it has actually shortened the transition time for many manufacturers!

EU MDR: Are ROW Device Sponsors Ready for the Ripple Effect?

Blog Posts26 Nov 2020

The long-awaited transition to the EU Medical Devices Regulation (MDR) is looming. The regulatory realm of medical devices is in a state of flux and poised on the brink of the...

2020 budget cash splash on high tech and science recovery. Australian science and technology sectors are talking about a ‘research revival’ as the Federal Government splashes the cash in the 2020 Budget.

Australian Government Cash Splash on High Tech Recovery

Blog Posts15 Oct 2020

Australian science and technology sectors are talking about a ‘research revival’ as the Federal Government splashes the cash in the 2020 Budget. 2020 Budget Cash Splash Thanks to COVID-19, early October...

TGA's new Product Information (PI) Form: If you need support to meet the 31 December 2020 deadline, we’re here to help.

The Pointy End of the TGA (PI) Reformatting Transition Period

Blog Posts20 Mar 2020

By now, we should all be very familiar with the new Form for providing Product Information (PI) for Australia. Each time you make a change to a PI, be it safety-related...

Therapeutic Product Commercialization - We may have a global market but do we really consider options outside of USA and EU enough when developing our strategy?

Therapeutic Product Commercialization Strategy

Blog Posts11 Mar 2020

We may have a global market but do we really consider options outside of USA and EU when developing our Therapeutic Product Commercialization strategy? The USA, EU/UK are large markets with...

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