Australia’s TGA Priority Review Pathway
How Australia’s TGA Priority Review Pathway Helps Speed Up Access to New Medicines. The ultimate goal of every regulatory submission is patient access. Whether seeking approval for a new prescription medicine or an additional indication for an existing drug, the objective remains the same — providing patients with the best possible treatment options as quickly…
Enter the Dragon: Navigating Hong Kong’s Medicines Regulatory System in 2024
The Year of the Dragon stands as a fitting emblem for Hong Kong’s medicines regulatory system, symbolising strength, resilience, and vigilant oversight
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.
Is Artificial Intelligence Becoming Too Smart for Regulators?
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 idea has come a long way from concept to reality. From enhancing photos for your social media page to detecting diseases from medical images
The Pointy End of the TGA (PI) Reformatting Transition Period
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 or otherwise, you’re required to provide the updated PI to TGA in the new format. The looming deadline for marketed product PIs to be
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
