MEDSAFE NZ Moves Ahead in 2020

Medsafe NZ has been working on a new therapeutic products regulatory regime to replace and modernise the regulatory arrangements for medicines.

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.

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.

More recent articles

  • Australia’s TGA Priority Review Pathway

    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…

  • Medsafe Rule of 2 Verification Pathway

    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…

  • Benefits of Bridging Clinical Trials in Australia

    Benefits of Bridging Clinical Trials in Australia

    BRIDGING STUDIESDo you need to ‘Bridge’ the gap? When developing your global strategy, bridging trials play a crucial role in ensuring that data from one population can be effectively applied to another. The main objective of bridging clinical trials is to determine whether the results from clinical trials conducted in one population (e.g., Caucasian) can…