Frequently Asked Questions

NEW ZEALAND

1. How long does it take to get approval for Clinical Trials to be conducted in New Zealand?
2. Is ICH-GCP (Good Clinical Practice) followed in New Zealand?
3. Is approval needed from Ethics Committees (EC's)/IRB's for a study in New Zealand, and if so, how long does it take, how often do EC's meet, and is there a combined process in the case of multi-centre studies?
4. Is payment required for SCOTT (Authority) approval and Ethics Committee approval in New Zealand?
5. Are Clinical Trials a requirement to get registration of new products in New Zealand? If so, what type of studies do you have to conduct?
6. Is it necessary to conduct post-marketing surveillance trials after registration of a new product? What is the purpose of doing post-marketing trials in New Zealand?
7. How is the study medication imported? Is approval required from Ethics Committees or the New Zealand Ministry of Health? Are any extra permits required to be applied, such as a CTIL (Clinical Trial Import Licence)?
8. Does a clinical trial conducted in New Zealand require a New Zealand sponsor?

AUSTRALIA

9. How long does it take to get approval for Clinical Trials to be conducted in Australia?
10. How does a sponsor know whether to submit a notification (CTN) or application (CTX) to the Therapeutic Goods Administration (TGA) in Australia?
11. Can any Human Research Ethics Committee (HREC)/IRB approve the clinical trial in Australia?
12. Is payment required for TGA notification (CTN) or approval (CTX) and HREC approval in Australia?
13. Does the sponsor of a Clinical Trial in Australia have to have an office within Australia?

NEW ZEALAND & AUSTRALIA

14. Does a study in New Zealand or Australia need to be registered?
15. What is ANZTPA and how will it affect clinical trials in New Zealand and Australia?

EUROPE

16. What is the European Clinical Trials Directive (EU Directive / CT Directive)?

Applicants should allow for a total time period of 2-3 months.

The Ministry of Health's (Medsafe) Standing Committee On Therapeutic Trials (SCOTT) approval process takes a maximum of 45 days, usually less. This is required for non-registered drug formulations, but NOT for medical devices, NOR new indications of NZ registered formulations.

Ethics Committee (EC) applications (see 3. below) can be submitted in parallel. SCOTT will initially issue a 'Recommend for Approval', which means it will give final approval once EC approval has been obtained. It only takes few days to get final approval once EC approval has been given.

Good Clinical Research Practice guidelines based on ICH-GCP have been followed in New Zealand since 1996. New Zealand-specific GCRP Guidelines have been available since 1998. More information can be obtained from Medsafe. New Zealand trial sites and personnel are familiar with the compliance requirements of ICH-GCP and the Declaration of Helsinki.

Ethics Committee approval is required for all research involving humans. Only one ethics committee review is required per study in New Zealand. If all sites for a study are within one region, that region's committee deals with it. If sites extend across more than one region, it is dealt with by the national committee only. It takes 1-2 months from submission to full approval. It's not a difficult process, but it's important to know the documents to prepare, the groups to be contacted and the processes to follow. Ethics Committees meet monthly (twice monthly in Auckland & Christchurch) except January, and require notice and prepared documents two weeks prior to a meeting to consider the application. For more information including agenda and meeting dates see www.newhealth.govt.nz/ethicscommittees

SCOTT applications cost NZ$6525 with no charge for Ethics Committee applications. Currency Conversion

Full pre-clinical and clinical safety, tolerability and efficacy data is required for registration of medicinal products and medical devices. Many companies use a similar dossier content and format to the one required by the CHMP in Europe.

NCE approval requires 14 months from submission to an opinion for MAAC (Medicines Approval Advisory Committee) approval, plus another 4-6 weeks for the announcement in the NZ Gazette. Extra time needs to be allowed if there are follow-up questions.

There is no formal requirement for any type of post-registration trials or surveillance, other than the usual spontaneous adverse event reporting that applies to all products. MAAC may recommend some type of post-marketing study for a product if it feels that it is warranted in a particular case.

Ministry of Health (Medsafe) approval is required for the trial before drugs can be imported into New Zealand. The Medsafe (SCOTT) approval letter states that it may be used as evidence of import approval if required. An import licence is not required. Export approval is not required for investigational product shipped from the U.S to New Zealand.

An application for a clinical trial of a medicine (whether approved for distribution in New Zealand or not) must be lodged by or in the name of a person or company resident in New Zealand.

An overseas company wishing to carry out a clinical trial of a medicine in New Zealand needs to have a New Zealand-based subsidiary or appoint a local individual or company as its New Zealand agent to act for it in New Zealand as the sponsor for the clinical trial concerned. The New Zealand subsidiary or agent is the sponsor legally responsible for the trial, and is the "applicant" when consent for the trial is being sought.

Where an overseas company or a local or overseas consultant acts on behalf of a New Zealand sponsor in submitting an application, a letter from the sponsor confirming the overseas company's or consultant's authority to act on the sponsor's behalf, for the specific clinical trial for which the application is made, should be forwarded to Medsafe either with the application or separately.

AUSTRALIA

Applicants should allow for a total time period of 2-3 months. Notification (CTN) or an application (CTX) is required to the TGA (Therapeutic Goods Administration). The CTX application can be made under 50 or 30 day review, and has associated costs.

Ethics approval is obtained from the applicable institutional HREC (Human Research Ethics Committee). The ethics application is required to be submitted 2-6 weeks prior to the ethics meeting. Average approval time depends on the ethics committee, and varies depending on the geographical area.

Either route can be used for clinical trials provided that the trial product is not entered on the Australian Register of Therapeutic Goods, including any new formulation of an existing product or any new route of administration; or is a registered or listed product outside the conditions of its marketing approval.

Over 95% of trials are approved by the CTN notification route, and the HREC has the responsibility for approving not only how acceptable the study is ethically, but also the safety and efficacy of the medicine or device, approval of the trial protocol and related scientific credibility.

A sponsor can conduct any number of trials under the CTX application without any further TGA assessment as long as the product in the study continues under the approvals usage guidelines. However each new trial must be notified to the TGA, but there is no fee for this additional notification under the CTX scheme.

If a CTN is submitted legally the sponsor does not have to wait for the TGA's (Therapeutic Goods Administration) acknowledgment letter before starting the study, although it is advisable to wait for acknowledgement in case there is anything that invalidates the notification.

Under the CTX scheme the sponsor must wait for TGA written approval.

Only ethics committees that are constituted and operating in accordance with the National Health and Medical Research Council's (NHMRC) National Statement on Ethical Conduct in Research Involving Humans can approve a clinical trial. Additionally the trial needs approval from the ethics committee with jurisdiction at that site (hospital, clinic etc). Additionally there is a private ethics committee registered with the NHMRC, that can be used for some sites: www.bellberry.com.au

CTN currently AUD $240 for each notification CTX 50-day review AUD $15,300 (all chemical, pharmaceutical and biological, pharmaco-toxicological and clinical data) CTX 30-day review AUD$1240 HREC's (ethics committees) charge AUD $3000 to AUD $5000 for an application. Currency Conversion

The sponsor of a clinical trial in Australia must be an Australian legal entity.

NEW ZEALAND & AUSTRALIA

It is a recommended that clinical trials are registered. They can be registered on the Australasian Clinical Trials Registry free of charge (www.actr.org.au). Since July 2005 the ICMJE (International Committee of Medical Journal Editors) has enforced a policy that they will no longer accept phase II trials for publication unless trials have been prospectively registered with a public domain registry that is accessible online. Additionally in May 2006 the World Health Organisation recommended that all interventional clinical trials should be registered.

ANZTPA is the Australia New Zealand Therapeutic Products Authority. The aim is to establish a joint agency to regulate therapeutic products replacing the current agencies of the Therapeutic Goods Administration (TGA) in Australia and the Medicines and Medical Devices Safety Authority (MedSafe) in New Zealand. This project is currently on hold (www.anztpa.org).

EUROPE

In May 2001, the current EU Directive was published on the conduct of clinical trials in Europe.

The EU Directive (2001/20/EC) relates "to the implementation of good clinical practice (GCP) in the conduct of clinical trials on medicinal products for human use'', and is aimed at the regulation of clinical trials within the European Union and was transposed by each EU country into its own law.

All interventional clinical trials are covered by the CT Directive and require authorisation by each EU country's regulatory body - such as the Medicines Control Agency (MCA) in the UK.

In effect, every interventional clinical trial involving medicinal products is covered, whoever sponsors it, whether industry, government, research council, charity or university.

The key points of the CT Directive are:

- Protection of clinical trial subjects
- Procedures for Ethics Committees
- Exchange of information between the regulatory bodies and the European Medicines Agency (EMEA)
- Standards for Good Clinical Practice (GCP) & Good Manufacturing Practice (GMP)
- Reporting of Serious Adverse Events (SAE's)
Ethics Committees

All clinical trials must be approved by an independent ethics committee. Articles 6 and 7 of the CT Directive define the procedures for Ethics Committees, including a time limit for decisions.

For further details on individual countries, please contact eu@beltas.com.

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