Blog Posts
Follow along as we discuss the latest changes across the pharmaceutical, biotechnology, medical technology and life science sectors.
Pharmaceutical Quality Assurance Australia and NZ
The Critical Importance of Quality Assurance (QA) in Drug Development, Clinical Trials, and Importation into Australia and New Zealand. Why Pharmaceutical Quality Assurance Matters Maintaining high-quality standards throughout every stage of drug development, including nonclinical research, clinical trials, manufacturing, supply chain, and importation, is essential for protecting patient safety, ensuring product efficacy, and fulfilling regulatory…
Australia and the ACCESS Consortium: Navigating Regulatory Collaboration
The Access Consortium is a coalition of like-minded regulatory authorities working together to promote greater regulatory collaboration and alignment of regulatory requirements. Learn how the ACCESS Consortium can streamline medicine approvals in Australia and partner countries, accelerating access to new therapies. Australia as an Early Entry Market for Medicines Australia is an increasingly attractive early…
Life Sciences Expansion Strategies Greater Bay Area – China
China’s Greater Bay Area (GBA) initiative aims to create a single, integrated economic zone, fostering innovation, connectivity, and environmental sustainability. We explore how the Greater Bay Area (GBA) is transforming life sciences and medical device access in China, with regulatory benefits and streamlined market entry opportunities. What is the Greater Bay Area (GBA)? The Greater…
News Releases
Stay up to date with the latest news and industry developments in Australia/New Zealand and beyond.
The Adjutor Healthcare Group and Axis Health Co Announce a Strategic Partnership to Drive Client Success
Sydney, June 2024 – The Adjutor Healthcare Group and Axis Health Co are excited to announce their strategic partnership. This collaboration, which combines the unique strengths and expertise of two industry powerhouses, aims to provide enhanced consulting services and comprehensive solutions specifically tailored to the needs of each client, enabling them to achieve exceptional results.…
The Adjutor Healthcare Group Expands Global Presence with the Establishment of Adjutor Healthcare Hong Kong
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, regulatory and commercialisation needs.
Moderna mRNA COVID-19 Vaccine Approved
09 August, 2021 – Moderna mRNA COVID-19 Vaccine Approved The Therapeutic Goods Administration (TGA) has provisionally approved Moderna’s mRNA vaccine for use in Australia, in record time. Australia’s fourth approved vaccine, one million doses are due to be released in the second half of September, 2021. The Spikevax (elasomeran) vaccine is provisionally approved and included…
Regulatory Announcements
Breaking news and updates about the regulation of therapeutic goods in Australia.
MEDSAFE NZ Moves Ahead in 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 medicines, and provide regulation of all therapeutic products. Whilst we are still waiting for the progression of the Therapeutic Products Bill through parliament, the
Consumer Insecurity / Vanity Targeted by TGA – Massive Fines
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 imposed via the Federal Court for misleading advertising by Peptide Clinics Australia (Peptide Clinics Pty Ltd), to the tune of $10 million (for breaches…