Running an interventional clinical trial in New Zealand means navigating two parallel systems: regulatory approval for the medicine or intervention itself, administered by Medsafe with expert committee review under the Health Research Council of New Zealand (HRC), and separate ethical review by a Health and Disability Ethics Committee (HDEC). This guide sets out how the pathway works, who does what, and how it differs from the notification-based scheme used across the Tasman in Australia.
Medsafe: New Zealand’s medicines regulator
Medsafe is the New Zealand Medicines and Medical Devices Safety Authority, a business unit of the Ministry of Health – Manatū Hauora. It is the country’s national regulatory authority for therapeutic products, responsible for pre-market and post-market oversight of medicines and, for clinical trial purposes, for administering the statutory approval process for trials involving new or investigational medicines.
Under section 30 of the Medicines Act 1981, a clinical trial of a ‘new medicine’ – broadly, one not already approved for use in New Zealand, or an approved medicine used outside the conditions of its existing approval – may not begin without the consent of the Director-General of Health. In practice, that statutory function is delegated to Medsafe, which receives applications, coordinates expert committee review, and issues the formal approval letter once a trial is authorised. That approval letter also serves as the documentation Customs requires to release imported investigational product into the country, so it is a practical prerequisite for supply as well as a legal one.
This is a materially different starting point from jurisdictions that rely on a notification-only scheme: New Zealand requires affirmative pre-commencement approval for trials of new medicines, not simply notice that a trial is about to start.
The Health Research Council’s role: SCOTT and GTAC
Medsafe does not review trial applications alone. Scientific and clinical assessment is carried out by expert committees hosted under the Health Research Council of New Zealand (HRC) – the same national body better known for administering New Zealand’s public health-research funding. Two HRC-affiliated committees do this work:
- SCOTT (Standing Committee on Therapeutic Trials): reviews applications for pharmaceutical-type medicines – the standard route for most drug trials.
- GTAC (Gene Technology Advisory Committee): reviews applications involving gene technology and related biotechnology-based therapies, alongside any applicable requirements under New Zealand’s gene technology and biosafety legislation.
Medsafe receives and processes the application, routes it to the relevant committee (SCOTT or GTAC depending on the product type), liaises between the committee and the applicant/sponsor during review, and issues the resulting approval letter once the committee has reached a decision. Sponsors and CTAs (clinical trial associates) coordinating a New Zealand site should treat SCOTT/GTAC review as the substantive scientific gate in the pathway, with Medsafe as the administrative and legal conduit around it.
Applications are submitted through New Zealand’s online Ethics RM system – the same portal used for HDEC ethics submissions – and Medsafe does not accept paper or emailed applications.
Ethics review: Health and Disability Ethics Committees (HDECs)
Regulatory (Medsafe/SCOTT/GTAC) approval and ethical review are separate, parallel requirements, not a single combined process. All clinical trials conducted in New Zealand require ethical approval from a Health and Disability Ethics Committee (HDEC), the national ethics committee system operated under the Ministry of Health, independent of whether the trial also needs Medsafe/SCOTT-GTAC regulatory sign-off. A trial of an already-approved medicine used within its approved conditions, for example, may not need Medsafe’s section 30 approval but will still need HDEC ethics approval before enrolling participants. Sponsors should plan for both tracks concurrently rather than assuming one satisfies the other, and should confirm current locality/site-specific authorisation requirements directly with the relevant district health service and Medsafe’s own guidance, since these operational details are updated more frequently than the underlying statutory framework.
Good Clinical Practice and the Clinical Trial Site Notification scheme
New Zealand trials are expected to comply with internationally recognised Good Clinical Practice standards – see CASRAI’s guide to What Is Good Clinical Practice (GCP)? and the ICH GCP and ICH E6(R2) reference standards – with New Zealand-specific detail set out in Medsafe’s own Guideline on the Regulation of Therapeutic Products in New Zealand (GRTPNZ). Medsafe also administers a Clinical Trial Site Notification scheme, through which it collects information on trial sites and maintains a list of sites that have notified compliance with GCP requirements, and a related notification pathway for sites housing patients in residence. This notification function is separate from – and should not be confused with – the statutory pre-commencement approval requirement described above.
How this differs from Australia’s TGA pathway
New Zealand and Australia share a great deal of clinical-trial infrastructure, including the joint ANZCTR (Australian New Zealand Clinical Trials Registry), but their underlying regulatory-approval mechanics are not the same system wearing two names:
- Australia uses the Therapeutic Goods Administration’s CTN and CTA schemes. The Clinical Trial Notification (CTN) pathway is fundamentally notification-based: the sponsor notifies the TGA and relies primarily on the reviewing Human Research Ethics Committee (HREC) and the trial site’s own institutional approval, without the TGA itself pre-approving the trial’s scientific merit in the ordinary case. The narrower Clinical Trial Approval (CTA) pathway, used less often, does involve TGA pre-approval.
- New Zealand centres on affirmative committee-based pre-approval for trials of new medicines: Medsafe, acting on delegated statutory authority and advised by HRC’s SCOTT or GTAC committees, must approve the trial before it can start – there is no equivalent notification-only default route for new-medicine trials.
In short: shared regional trial registration (ANZCTR) and a broadly harmonised expectation of ICH GCP conduct sit on top of two structurally different national approval mechanisms. A sponsor running a multi-site trial across both countries needs a New Zealand-specific regulatory submission and HDEC ethics application in addition to, not instead of, whatever Australian TGA/HREC pathway applies to the Australian sites – and should not assume that clearing one country’s process satisfies the other’s. See CASRAI’s guide to Australia’s TGA CTN/CTA schemes for the Australian side of that comparison, and Canada’s Clinical Trial Regulatory Framework for a further contrast with a Health Canada/REB-based model.
Practical checklist for sponsors and research offices
- Confirm early whether the investigational product qualifies as a ‘new medicine’ under the Medicines Act 1981 – this determines whether Medsafe/section 30 approval is required at all.
- Route the application to Medsafe via Ethics RM, expecting review by SCOTT (pharmaceutical-type medicines) or GTAC (gene technology products) as applicable.
- Submit the parallel HDEC ethics application – do not treat regulatory approval and ethics approval as sequential dependencies of each other; plan both tracks together.
- Register the trial with ANZCTR to meet registry/publication expectations, separately from the Medsafe/HDEC approvals themselves.
- Retain Medsafe’s approval letter, since it also functions as the import/customs clearance document for investigational product.
- Verify current processing timeframes, fees, and any locality-authorisation specifics directly against Medsafe’s current published guidance before finalising a project timeline, since operational details of this kind are updated more often than the statutory framework and are outside the scope of this guide to state precisely.
Frequently asked questions
Is Medsafe approval required for every clinical trial in New Zealand?
No. Medsafe’s statutory approval under section 30 of the Medicines Act 1981 applies specifically to trials of ‘new medicines’ – broadly, unapproved products or approved medicines used outside their approved conditions. Trials using already-approved medicines within their approved conditions may not need this regulatory approval step, but every clinical trial conducted in New Zealand still requires HDEC ethics approval regardless.
What is the difference between SCOTT and GTAC?
Both are expert committees hosted by the Health Research Council of New Zealand that review clinical trial applications on Medsafe’s behalf. SCOTT (Standing Committee on Therapeutic Trials) reviews pharmaceutical-type medicine trials; GTAC (Gene Technology Advisory Committee) reviews trials involving gene technology and related biotechnology therapies.
Does registering a trial in ANZCTR satisfy New Zealand’s regulatory or ethics requirements?
No. ANZCTR is a public trial registry shared with Australia; registering there addresses registration/transparency expectations but is entirely separate from, and does not substitute for, Medsafe/SCOTT-GTAC regulatory approval or HDEC ethics approval in New Zealand.
Is New Zealand’s clinical trial approval process the same as Australia’s TGA CTN scheme?
No, despite the two countries sharing ANZCTR and a broadly harmonised GCP expectation. Australia’s standard CTN pathway is largely notification-based, relying on HREC and institutional review rather than upfront TGA approval in the ordinary case. New Zealand instead requires affirmative pre-commencement committee approval, via Medsafe with SCOTT/GTAC review, for trials of new medicines.
