4. Regulatory Authority (RA)/Competent Authority (CA)

4.1 Provide a list of documents needed to be submitted for RA/CA review and approval including the number of copies and/or translations as relevant. 

Details of the documents required by Medsafe are linked here.

Specific to Clinical Trials:

• Application form please login to Ethics Review Manager (ETHICS RM)
• Clinical Trial Site Notification Form (Word 17 KB, 2 pages)

4.2 Time required for RA/CA review and approval process and turnaround time if any query is raised during the review process. 

The timeline of approvals is approximately 45 Days for the Director-General’s decision. 

Within 45 calendar days of receiving the application, the applicant will be notified about the outcome of the Director-General’s consideration of the HRC’s recommendation and will liaise with the applicant regarding any proposed conditions of approval or requests for further information.

If the Director-General’s decision is to approve the trial, a letter will be issued by Medsafe. If the decision is to decline an application, the reasons for this decision will be provided to the applicant. The applicant then has 28 days in which to lodge an appeal with the Medicines Review Committee. 

4.3 Does the regulation support electronic submission?

Yes, applications for approval of clinical trials must be made using the online system. Paper-based/emailed applications will not be accepted. An online application for clinical trial approval is made using NZ Online at https://nz.forms.ethicalreviewmanager.com.

4.4 Does the regulation require the applicant to be a Principal Investigator (PI)/Chief Investigator (CI)?

An application for approval of a clinical trial should be made by the person responsible for the trial in New Zealand. This person is referred to in the Medicines Act as ‘the applicant’. The applicant must be a person in New Zealand who takes legal responsibility for the conduct of the trial in New Zealand. For more information on the responsibilities of the applicant, see sections 4.3, 5.2.1, and 6 of the Guideline on the Regulation of Therapeutic Products in New Zealand.

Once the trial is approved, the applicant becomes the sponsor, assuming responsibility (including legal liability) for the trial in New Zealand. 

In the case of a multi-center trial that is being conducted and administered by a research body outside New Zealand, it is common for the principal investigator in New Zealand (or a local person or company, such as a clinical research organization acting in that capacity) to undertake the role of applicant (and subsequently, the sponsor).

https://www.medsafe.govt.nz/regulatory/Guideline/GRTPNZ/Part11.pdf

4.5 Please describe the process of RA/CA submission for clinical trial approval. 

• Applications for approval of clinical trials must be made using the online system. Paper-based/emailed applications will not be accepted. An online application for clinical trial approval is made using NZ Online at https://nz.forms.ethicalreviewmanager.com.
• The applicant must first create an account to get access to SCOTT / GTAC and HDEC application forms.
• An application for approval of a clinical trial should be made by the person responsible for the trial in New Zealand. The applicant must be a person in New Zealand who takes legal responsibility for the conduct of the trial in New Zealand.
• On receipt of the online application, Medsafe will issue an acknowledgment letter and an invoice to the applicant within 7 days and Medsafe will forward the application to the Health Research Council of New Zealand (HRC). The applicant can communicate with Medsafe at clinicaltrials@medsafe.govt.nz.
• Application for Ethics Committee approval can be made at any time before, during, or after consideration of the application for clinical trial approval.
• Within 45 calendar days of receiving the application, the applicant will be notified about the outcome of the Director-General’s consideration of the HRC’s recommendation and will liaise with the applicant regarding any proposed conditions of approval or requests for further information.
• If the Director-General’s decision is to approve the trial, a letter will be issued by Medsafe. If the decision is to decline an application, the reasons for this decision will be provided to the applicant. The applicant then has 28 days in which to lodge an appeal with the Medicines Review Committee. 

4.6 Does the RA/CA provide written acknowledgment of the submitted application? If not, describe how the application is tracked.

Yes. Upon receipt of the application, Medsafe will issue an acknowledgment letter.

4.7 What is the relevant RA/CA fee in local currency/USD? Please provide as much information as possible (e.g. if the fee is different for notification/approval, initial submission, amendment, study with IMPD and study without IMPD, etc.)

The current Medsafe fee schedule is provided in the link below. All fees are presented in New Zealand Dollars (NZD). 

https://www.medsafe.govt.nz/regulatory/Fees/FeesScheduleJuly2022.pdf

4.8 Does RA/CA accept checks or can payment be made electronically? Please provide details on (1) A/C number; (2) A/C Name; (3) Sort Code; (4) Swift Code; (5) Bank address, etc. Where can remittance advice notices be sent?

Medsafe accepts online payment by Visa or MasterCard credit cards. A service charge of 2% is applied.

https://www.medsafe.govt.nz/regulatory/CreditCard/CreditCard.asp

Payment is also accepted by Electronic Funds Transfer or by cheque, which does not attract a convenience fee charge. Details on how to make a payment by these methods is listed on the invoice remittance advice.

4.9 Is there any guidance tool available for making an electronic application? If yes, provide the link and/or step-by-step instructions.

There is no specific guidance available but all queries regarding an application for approval of a clinical trial can be directed to clinicaltrials@medsafe.govt.nz

4.10 Does RA/CA require any screenshots/mock screens for participant-facing materials?

It depends on the study and the type of study materials. If the study relies upon electronic versions of patient-facing materials, then these should be provided for ethics approval.