Renowned for the efficiency of its regulatory and clinical trial research processes, New Zealand offers a robust environment for pharmaceutical drug development. By developing and trialing products in New Zealand, companies can benefit from streamlined processes and potentially accelerate time to market.
Douglas CDMO, a New Zealand-based Contract Development and Manufacturing Organization (CDMO), traces its roots back to 1967. Douglas distinguishes itself through its specialization in high-potency softgel and liquid formulations and its commitment to bespoke, client-centric services.
In this article, Rhona Macdonald, Head of Clinical Research at Douglas, discusses the advantages of the New Zealand regulatory and ethics processes, how they work, and why international companies should seriously consider New Zealand as the place to help bring products to market.
New Zealand has robust, clear processes for ethics and regulatory approval
Originally from the United Kingdom, Rhona’s background includes medical care and overseeing clinical trial operations. She has been with Douglas for over eight years and has extensive in-depth knowledge of the regulatory and ethics requirements for conducting clinical trials in New Zealand. Rhona describes the regulatory and ethics processes when applying to conduct clinical trials as “very structured, with time limits for responses, to which all parties adhere.”
Before a study can be initiated, it must undergo a thorough review to ensure it meets all local regulatory and ethical standards. This review is undertaken by two organizations, “SCOTT” and “HDEC”.
The Standing Committee on Therapeutic Trials (SCOTT) conduct the regulatory review in accordance with Section 30 of the Medicines Act 1981 NZ Ministry of Health. When reviewing clinical trial applications, they have a particular focus on the scientific aspects.
The SCOTT Committee is made up of 14 professors and leading doctors who together cover all therapeutic areas. The SCOTT review of applications can take up to 45 calendar days, however, Rhona comments that “the average turnaround time for review is typically a lot shorter.” It can be considerably shorter than the average turnaround times in the US of three months.
Health and Disability Ethics Committee (HDEC) is New Zealand’s Institutional Review Board/International Ethics Committee, with meetings held weekly to review research submissions and ongoing studies involving trial participants.
HDEC is responsible for assessing ethics applications for clinical trials, with its primary function of protecting trial participants. A review committee quorum is made up of five members, including at least two lay-members, and at least two non-lay members. The review of applications made to the HDEC can take up to 35 calendar days.
Applications to both SCOTT and HDEC are done on user-friendly, secure online platforms and can be completed in parallel. Douglas CDMO will complete the SCOTT on behalf of their clients in addition to supporting the lead trial site complete the HDEC submission.
Douglas can help international companies “jump ahead” with Phase I (first-in-human) trials conducted in New Zealand
To apply to conduct clinical trials in New Zealand, a company must have a local entity. Douglas CDMO can serve as an experienced New Zealand-based partner for international companies, enabling them to conduct their first-in-human trials here. Phase II and Phase III studies can also be conducted in New Zealand. Data from trials conducted in New Zealand can then be used to support applications to the FDA and/or other regulatory authorities.
In Rhona’s experience, getting to Phase I studies can be more straightforward and cost-efficient in New Zealand, as a US Pre-Investigational Drug (IND) submission is not required. She has seen this allow Phase I studies to start running while the additional requirements of the FDA’s IND process were being addressed concurrently:
“A company, in theory, can get into first-in-human trials much quicker here in New Zealand than in the US. In the US, an IND submission is required for a first-in-human trial, which isn’t required in New Zealand. There is the potential for considerable time savings for companies looking to initiate their first-in-human trials here.”
The team at Douglas has intricate knowledge of the documentation requirements for SCOTT and HDEC submissions, and their local expertise helps them pre-empt issues that may arise. This has the potential to reduce the delays and additional costs that can occur if clinical trial submissions are incomplete.
Having its headquarters in New Zealand, Douglas CDMO offers another strategic advantage to its global clientele. US and European clients frequently delegate tasks at the close of their workday, enabling the New Zealand team to address them during their own work hours. Operating across different time zones facilitates extended support hours and swift responses.
Rhona concludes that companies exploring contract development options will benefit from Douglas’ expertise in handling highly potent small molecules and tackling complex formulation challenges, alongside leveraging New Zealand’s robust regulatory advantages. She says companies should seriously consider taking advantage of the regulatory benefits, and highlights Douglas as an essential partner for accelerating approvals and navigating the regulatory pathway.
“New Zealand has a strong history in clinical research and robust review of submissions. We excel in recruitment and maintain good subject retention. Our data integrity is high, and protocol deviations are minimal. We punch well above our weight, and with Douglas, you are supported by an experienced partner that will help you navigate and benefit from the potential regulatory time and cost savings.”