Blog Posts
Follow along as we discuss the latest changes across the pharmaceutical, biotechnology, medical technology and life science sectors.
Understanding TGA GMP Clearance
Understanding TGA Good Manufacturing Practice (GMP) requirements for Australian Regulatory Submissions Good Manufacturing Practice (GMP) is vital in ensuring the quality, safety, and efficacy of the therapeutic goods for human use (including sunscreens). In Australia, the Therapeutic Goods Administration (TGA) oversees the implementation and enforcement of GMP standards to uphold the integrity of the pharmaceutical…
Choosing the Right Regulatory Affairs Consultant
Whether you are part of an established team, a start-up, an SME, or a founder, navigating the stringent requirements of the Medical Technology, Biotechnology, and Pharmaceutical (MTP) sectors can be complex and challenging. This is where partnering with the right Regulatory Affairs Consultant becomes invaluable. Understanding the Role of a Regulatory Affairs Consultant A regulatory…
Cell and Gene Therapies Regulation
Navigating the Regulation of Cell and Gene Therapies in Australia and New Zealand Globally, cell and gene therapies are revolutionising modern medicine, offering groundbreaking treatments for life-threatening conditions including cancer, genetic disorders and rare diseases. However, despite the pace of scientific innovation, regulatory frameworks in many countries, including Australia and New Zealand, have struggled to…
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…