5. Investigator and Investigational Product

5.1 Does local regulation require PI/CI to be approved/registered by any health authority (e.g., RA/EC)?  

No, not specifically. The principal investigator must be a resident of New Zealand. All investigators must have New Zealand-recognized qualifications.

5.2 Does local regulation require any specific documents if PI/CI is based outside the country?

Not applicable. The principal investigator must be a resident of New Zealand.

5.3 Does local authority allow electronic ICF administration, including electronic signatures?

There is no specific guidance in relation to electronic sign-off of ICFs provided that ICH GCP(R2) and other applicable regulations are complied with, it may be possible to obtain informed consent remotely. The procedure needs to be described in detail in the study protocol and justified.

The rules around electronic signatures in New Zealand are now contained in Part 4 of the Contract and Commercial Law Act 2017, although they are the same rules that were previously in the Electronic Transactions Act 2002. Generally, the Act permits the use of electronic signatures wherever normally written signatures are required, although there are some documents for which electronic signatures cannot be used such as wills, affidavits, and powers of attorney.

Under section 226 of the Act, a legal requirement for a signature is met as long as the electronic signature:

• Adequately identifies the signatory and adequately indicates the signatory’s approval of the information to which the signature relates.
• Is as reliable as is appropriate given the purpose for which, and the circumstances in which, the signature is required.

That section goes on to say that if the signature relates to information that is legally required to be given to a person, the person must consent to receive the electronic signature. In the case of agreements and deeds, there is not generally any legal requirement that the information be given to the other person, so the consent requirement does not usually apply.

Electronic signatures can be used whether the signature must be witnessed or not. A best practice is for the witness to be physically present, even when an electronic signature is required. However, there have been some practices put in place in order to permit virtual witnessing, especially during the COVID-19 pandemic. These require additional safeguards and evidence to show that the witness actually saw the signature being applied, even though they were not physically present.

https://www.ajpark.com/insights/using-electronic-signatures-in-new-zealand-and-australia/

5.4 Does local regulation require ICF to be administered as audio/visual and do these need to be recorded?

Yes. Please refer to section 5.3 above regarding witnessing electronic signatures.

5.5 Is there any specific information/requirement on data capture/management (e.g., privacy regulations, etc.)?

Health Information, including practices relating to the management of data from clinical trials, is governed by the Health Information Privacy Code 2020. 

https://www.privacy.org.nz/privacy-act-2020/codes-of-practice/hipc2020/

5.6 If a clinical study involves the study product as OTC and this is provided via pharmacy/amazon, etc., are there any specific regulations for IP management that need to be followed?

No.

5.7 For a marketed study product/OTC, can a participant be compensated after confirmation of the purchased study product, or upfront prior to product acquisition? Does compensation in any way impact how the study is viewed (i.e., RWE vs. Interventional Study)?

There is currently no guidance around this.

5.8 Is it permitted to pay participant stipends (i.e., is it permitted to pay the patients for their participation in the clinical trial)? If so, what is the average range?

Participants may receive “reasonable” reimbursement for the costs associated with their participation in the trial. There is no guidance as to what is considered “reasonable”.

5.9 Specific labeling requirements for clinical study product

Section 30(7)(b) of the Medicines Act of 1981 requires that every label on every package of medicine used in a clinical trial must have the words “To be used by qualified investigators only”. It is Medsafe’s practice to accept these words or words of similar meaning. The investigational product should be labeled according to Annex 13 of the Code, which requires the name, address, and telephone number of the sponsor, contract research organization, or investigator (the main contact for information on the product, clinical trial, and emergency unblinding). 

The New Zealand contact details must be used, in the event that an emergency occurs, and the sponsor or Principal Investigator has to be contacted. The address and telephone number of the main contact for information on the product, clinical trial, and emergency unblinding need not appear on the label if the subject has been given a leaflet or card that provides these details and has been instructed to keep this in their possession at all times.

5.10 What documents need to be submitted (including relevant fee if any), and to whom, if a permit is needed for an investigational/study product being shipped from outside the country? Are there any specific requirements for biologics?

Import

Medicines and Treatments

• Ministry of Health (Medsafe) approval is required for the trial before drugs can be imported into New Zealand.
• The Medsafe Standing Committee On Therapeutic Trials (SCOTT) Approval Letter can be used as evidence of import approval if required.
• An import license is not required.
• Export approval is not required for investigational products shipped from the U.S. to New Zealand.

Materials used in Clinical trials

• All imports into New Zealand are subject to the Ministry of Agriculture & Forestry (MAF) and New Zealand Customs Import regulations.
• A commercial invoice is required to accompany all goods. 

5.11 What is the turn-around time to get an import permit?

An import permit is not required.  

5.12 Does local authority allow the destruction of clinical supplies at an off-site location (e.g. third-party vendor in or outside the country) after study completion? Are certificates of destruction required?

There are no specified requirements around the destruction of materials.