Regulations

Clinical Research in New Zealand

Experienced research personnel around New Zealand conduct local and international clinical research at public and private hospitals, universities, medical schools and research institutions.

The New Zealand Advantage

Speciality phase 1 clinical trial units are established in New Zealand. Both local and multinational Clinical Research Organisations have a strong presence in New Zealand and many international Pharmaceutical companies conduct their research in New Zealand.

The New Zealand Advantage:

  • Experienced and innovative researchers
  • Excellent recruitment and retention rates
  • Quality of data (ICH-GCP and FDA standards)
  • Quality research infrastructure
  • Pragmatic regulatory environment
  • High medical practice standards similar to those of Europe and USA
  • Cost effective research solutions
  • R&D Tax Incentive for eligible R&D activities

Clinical Trials in New Zealand must be registered. The Australian and New Zealand Clinical Trial Registry (ANZCTR) is available for registration of New Zealand trials, however other registries are also accepted.

The ANZCTR meets the requirements of the ICMJE register policy and is consistent with the proposed WHO portal.

Regulatory Approach

Regulatory Approval in New Zealand is straight forward, one approval covers all sites, and it is required for either:

  • conducting a clinical trial involving a non-licensed product
  • conducting a clinical trial involving a licensed product that is to be investigated via a new route or dose
Section 30 of the Medicines Act requires clinical trials involving new medicines, including pharmacokinetic, bioequivalence and first-in-human studies be approved by the Director-General of Health.
The application and approval process for clinical trials is administered by Medsafe (the medicines and medical devices regulatory authority of New Zealand).
An application is received by Medsafe. Upon receipt of the online application, Medsafe will send an acknowledgement letter and an invoice to the applicant within 7 days. Payment should be made within 7 days.
Medsafe will forward the application to the Health Research Council of New Zealand (HRC).
The HRC maintains two standing committees to consider clinical trial applications. The Standing Committee On Therapeutic Trials (SCOTT) considers applications for pharmaceutical-type medicines.
The Gene Technology Advisory Committee (GTAC) considers applications for trials involving gene and other biotechnology therapies.
Following consideration of the application by the relevant standing committee (SCOTT or GTAC), the HRC will convey a recommendation for approval to Medsafe. Clinical trials may be; Approved, Not Approved, Approved subject to certain conditions, or a Request for further information may be made.
The applicant will be notified of the outcome within 45 calendar days of an application being received by Medsafe.
Regulatory applications can be submitted in parallel with Ethics Committee applications.

Section 30 of the Medicines Act requires clinical trials involving new medicines, including pharmacokinetic, bioequivalence and first-in-human studies be approved by the Director-General of Health.

The application and approval process for clinical trials is administered by Medsafe (the medicines and medical devices regulatory authority of New Zealand).

An application is received by Medsafe. Upon receipt of the online application, Medsafe will send an acknowledgement letter and an invoice to the applicant within 7 days. Payment should be made within 7 days.

Medsafe will forward the application to the Health Research Council of New Zealand (HRC).

The HRC maintains two standing committees to consider clinical trial applications.

The Standing Committee On Therapeutic Trials (SCOTT) considers applications for pharmaceutical-type medicines.

The Gene Technology Advisory Committee (GTAC) considers applications for trials involving gene and other biotechnology therapies.

Following consideration of the application by the relevant standing committee (SCOTT or GTAC), the HRC will convey a recommendation for approval to Medsafe. Clinical trials may be; Approved, Not Approved, Approved subject to certain conditions, or a Request for further information may be made.

The applicant will be notified of the outcome within 45 calendar days of an application being received by Medsafe.

Regulatory applications can be submitted in parallel with Ethics Committee applications

All communication regarding an application for approval of a clinical trial must be addressed to the Clinical Trial Coordinator at Medsafe.

The email address is: clinicaltrials@medsafe.govt.nz

For further information regarding the approval process, refer to the Guideline on the Regulation of Therapeutic Products in New Zealand, Part 11: Clinical trials – regulatory approval and good clinical practice requirements.

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

Ethics Approval

National Ethics Advisory Committee (NEAC) – Kāhui Matatika o te Motu

The National Ethics Advisory Committee (NEAC) is a committee set up under New Zealand legislation to advise the Minister of Health on ethical issues in health services and research, and determine national ethical standards for the health sector.

Health and Disability Ethics Committees (HDEC)

The Health and Disability Ethics Committees (HDECs) check that proposed health and disability research meets or exceeds established ethical standards determined by NEAC. These ethical standards are contained in the streamlined ethical guidelines for health and disability research(revised July 2012). These standards apply to all health and disability research, regardless of whether HDEC review is required for that research.

For information and advice on the ethical review of studies by a Health and Disability Ethics Committee visit the HDEC website. All applications to HDECs must be submitted through the Online Forms Website.

Materials Shipping

Transporting Clinical Trial Materials

New Zealand is well connected to important international centres via global transportation networks.

Importing Materials

All imports into New Zealand are subject to Ministry for Primary Industries (MPI) and New Zealand Customs Import regulations. Some goods may also be subject to the requirement for a third party agency approval to import. For example, approval by the Ministry of Health – Medsafe Division is required to import medicine or new medicine into New Zealand.

A commercial invoice is required to accompany all goods. The commercial invoice should be on supplier letterhead and must specify the name and address of the importer and consignee, the terms of trade (International Chamber of Commerce – INCO terms), details of goods (quantity, description and value of each item), country of origin and invoice currency. In order to ensure the accuracy of the Customs import entry, each item should also show the applicable harmonised tariff code.

For detailed information about New Zealand’s importing requirements, please visit the following websites:

Ministry for Primary Industries  (MPI)
New Zealand Customs Service
Medicines Act 1981
Medsafe

Exporting Materials

New Zealand is well serviced by major international specialist and consolidator couriers. Typical transit times achieved ex-Auckland are:

Asia Pacific Region
Kuala Lumpur 36 hours
Mumbai 48 hours
Shanghai 48 hours
Singapore 36 hours
Sydney 24 hours

USA
Los Angeles 36 hours

Europe
Brussels 48 hours
Frankfurt 48 hours
London 48 hours
Paris 48 hours

Transporting Clinical Trial Materials in New Zealand

The safe and compliant transport of clinical trial material is extremely important. Personnel involved in the preparation of clinical trial material for transport, and those undertaking the responsibility as the shipper, have specific responsibilities for ensuring material is prepared and transported in accordance with national and international regulations applicable to the transport mode. It is therefore critical that personnel involved in the transport of clinical trial material become familiar with and remain cognisant of their responsibilities, and comply with all relevant regulatory requirements, especially when offering material classified as dangerous goods.

In New Zealand, the New Zealand Civil Aviation Authority (NZCAA) is responsible for all aspects of dangerous goods transport by air, to, from and within New Zealand. Shippers offering dangerous goods for air transport must comply with the NZCAA Rule Part 92. Shippers offering dangerous goods to a member airline of the International Air Transport Association (IATA) must also comply with the IATA Dangerous Goods Regulations (DGR). Dangerous goods shipping training courses in New Zealand must be conducted by an organisation with an aviation training certificate issued under Part 141 of the Civil Aviation Rule, or an organisation holding a current IATA dangerous goods training programme certificate of accreditation. Organisations certified by the NZCAA to conduct dangerous goods training courses are listed on the NZCAA website. Cold chain management awareness courses are also available and can include the preparation of products for air transport.

Contacts

Medsafe
Medsafe General Enquiries:
Phone: (04) 819 6800
P O Box 5013
Wellington
New Zealand

National Co-ordinator of HDECs
HDEC Enquiries:
Phone: 0800 4 ETHICS (or from outside NZ +64 4 819 6877)
Ethics Committees
Ministry of Health
PO Box 5013
Wellington 6145
New Zealand