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 Guidelines on the Regulation of Therapeutic Products in New Zealand are being modernised in parallel.
While some parts of the guidance were updated in 2018, other mooted changes seem to have been in draft for a long time. In particular, the medical device regulatory update which is still under construction on the Medsafe New Zealand website.
The most recent changes have been to Parts 2 (New and Changed Medicines) and 7 (Advertising) of the guidance documents. However, only minor updates were made to Part 2. These sought to clarify and regularise aspects that had previously been discussed with industry, such as acceptance of different dossier formats. The inclusion of some nice decision trees is a welcome addition.
We all had a sigh of relief to see that, while not mandatory, either NeeS (Non-eCTD electronic Submissions) OR eCTD format submissions are now possible. But, let’s not get too excited about this. Medsafe NZ does not have full functionality for eCTDs and therefore, lifecycle management is still a challenge.
Ideally, Medsafe NZ still prefer to see a hyperlinked Table of Contents, rather than an index file. And, we still have one foot in the land of paper submissions with a mandatory hardcopy of Module 1 to be provided together with two electronic copies of the full dossier (Modules 1-5). Acceptable electronic media is limited to CDs and DVDs only.
An overview of the status of Medsafe guidance documents is provided in the table below
Status of Medsafe NZ Guidance Documents – Feb 2020
|1||Overview of Therapeutic Products Regulation||Ed 1.0||Oct 2014|
|2||Obtaining Approval for New and Changed Medicines and Related Products||Ed 1.1||Oct 2019|
|3||Medical Devices – under construction||2003 to 2015|
|4||Manufacture of Medicines||Ed 1.1||Sep 2018|
|5||Labelling of Medicines & Related Products||Ed 1.6||Feb 2018|
|6||Bioequivalence of Medicines||Ed 2.0||Feb 2018|
|7||Advertising of Therapeutic Products||Ed 2.0||Dec 2019|
Part 7 advertising guidance had a major update and is very clear and readable in terms of what is allowable for advertising of medical devices, medicines (prescription, OTC, restricted in New Zealand. This includes internet, mail order, point of sale and direct marketing advertisements as well as communications to health professionals.
Of note, and something that often catches out Sponsors in their website advertising, is that testimonials must not be used.
For all your regulatory and advertising needs in New Zealand, contact the local experts.