Medsafe Rule of 2 Verification Pathway
Medsafe Rule of 2 Verification Pathway= Faster access to medicines The proposed Verification Pathway aims to accelerate market access for certain medicines by enabling Medsafe approval within 30 days, provided they’ve already been approved in two recognised overseas jurisdictions. This initiative is part of the Medicines Amendment Bill, now open for public consultation until 19…
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…
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
