Welcome Everyone to 2019 and our new Blog, keeping you up to date with regulatory changes in Australia and New Zealand and our activities worldwide.
We’ve been busy over the break, updating our websites, contact lists, LinkedIn connections and general housekeeping. It’s always good to begin the new year afresh. On that note, regarding New Zealand Regulatory Affairs 2019 – we are pleased to advise that Medsafe NZ has released a consultation document on the proposed Therapeutic Products Regulatory Scheme.
The deadline for comments is 18th April 2019 and you can access your copy online here –
The biggest change proposed is the inclusion of medical devices and cell and tissue-based products which are not fully regulated at the moment. Under the new scheme, Medsafe is proposing to regulate the cell and tissue sector using the European approach, which distinguishes between cells and tissues that are minimally manipulated and those that are engineered. This also mirrors the Australian TGA approach to cell and tissue product regulation, that was updated in 2018.
Products containing, or consisting exclusively of, non-viable human or animal cells and/or tissues, which do not contain any viable cells or tissues and which do not act principally by pharmacological, immunological or metabolic action, would be regulated as a medical device under the new scheme.
The regulation of medical devices in NZ has not had a substantial update since the Medicines Act 1981. The new scheme would include a full complement of pre- and post-market controls across the medical device product lifecycle. The intention is to adopt the regulatory model developed by the Global Harmonisation Taskforce (GHTF), as amended by the International Medical Device Regulators Forum (IMDRF).
We’ll be continuing to watch the changes in NZ with interest and advising you of developments as they occur.
For New Zealand regulatory affairs support, please contact us.