Human Medicines

How are human medicines regulated in New Zealand?

A company wishing to market a medicine that has not previously been marketed in New Zealand must obtain the consent of the Minister of Health (or his or her delegate) to distribute a "new medicine". New medicines fall into three categories:

The pre-market approval system for medicines is managed by Medsafe (the Medicines and Medical Devices Safety Authority). Data that satisfactorily establish the quality, safety and efficacy of the product must be submitted for evaluation before consent can be granted. Standards applied are derived form those required by other overseas regulators and are based on the guidelines and standards published by the International Conference on Harmonization and Committee for Proprietary Medicinal Products (now known as the Committee for Medicinal Products for Human Use; see Medsafe's regulatory guidelines).

Once a medicine is approved and on the market it is subject to post-marketing surveillance. Aspects of this surveillance are carried out for Medsafe by the Centre for Adverse Reactions Monitoring, based at the University of Otago. They monitor the safety of medicines and medical devices in use in New Zealand and elsewhere. Products shown to be unsafe are removed from the market, and prescribers are advised about new safety information for products. Post-marketing surveillance involves:

The Medicines Adverse Reactions Committee (MARC) is a ministerial advisory committee that makes recommendations on appropriate action to be taken for medical safety issues. Members of the Committee are practising medical practitioners in a range of specialty areas.

More detailed information on how medicines are regulated can be found in the New Zealand Regulatory Guidelines for Medicines, Vol 1, available on Medsafe's website.

What is regulated as a human medicine?

Medicines and several other products used for therapeutic purposes are regulated by Medsafe, New Zealand's Medicines and Medical Devices Safety Authority. Treatment, diagnosis and prevention of disease or the modification of a physiological function (such as digestion) are all considered therapeutics. Therapeutics also include products such as anaesthetics, contact lens cleansers, contraceptives, and controlled drugs ("narcotics") that are used as medicines.

Dental cleaning products, cosmetics or herbal remedies that have, or claim to have, therapeutic properties are also regulated. For example, a plant that produces a substance used to lower cholesterol levels, fluoride toothpastes, throat lozenges and medicated wound dressings require regulatory approval. Pregnancy test kits are also regulated as medicines.

A pre-market approval is required for both totally new medicines and medicines to which changes (such as a changed formulation or a new site of manufacture) have been made.

Products containing substances listed as prescription, restricted or pharmacy-only medicines are examined carefully to determine if they are being marketed for a therapeutic purpose or are intended to deliver a therapeutic purpose before a decision is taken not to regulate within the Medicines Act.

What is not regulated as a human medicine?

Products that make no specific therapeutic claim are not regulated as medicines. An example would be a herbal product that claims only to be "beneficial for the digestive system". In contrast, a herbal product that, for example, claims to be "good for abdominal cramps" would be considered a medicine since it purports to relieve a specific complaint or condition.

Most medical devices (such as instruments, bandages and dental fillings) do not currently require formal evaluation and approval before distribution in New Zealand. Medical devices must, however, be registered with Medsafe, and its website has an on-line Web-Assisted Notification Database (WAND) for this purpose. Medical devices will have to meet relevant international standards for good manufacturing practice and other requirements.

The requirements for approval of medical devices are likely to change when the new Trans-Tasman Joint Therapeutics Agency supercedes Medsafe to regulate therapeutic products in 2006. For more information about requirements for medical devices talk to Medsafe.

What is not allowed?

Biotechnical procedures can be listed as "restricted procedures" in Part 7A of the Medicines Act. Currently only xenotransplantation (introducing cells, tissues or organs from animals into humans) is listed as a restricted procedure. These can only be authorised by the Minister of Health. To be approved such procedures must not pose an unacceptable risk to the health and safety of the public, and any ethical, cultural, and spiritual issues associated with the procedure must have been adequately addressed.

The Human Assisted Reproductive Technology (HART) Act bans reproductive cloning of humans (ie production of a human) but not therapeutic cloning (ie using cloning to produce stem cells). The HART Act also bans genetic modification of gametes and embryos for reproductive purposes, and the use of gametes from foetuses for reproductive purposes. Selection of an embryo on the basis of sex is only permitted where it is to prevent or treat a genetic disorder or disease. Selection of an embryo on the basis of its sex for other purposes is not allowed.

Why are medicines regulated?

Use of medicines can have both risks and benefits. Government intervention and regulation is required to protect public health and standards of safety for medicines are higher than for other products. Regulation is to ensure that:

Regulatory Process

Medsafe/MAAC Assessment
Minister of Health Approval
Clinical Trials
Assessment by the Standing Committee On Therapeutic Trials (SCOTT)
Assessment by the Gene Technology Advisory Committee (GTAC)
Assessment by a Human Ethics Committee
How can I find out about decisions?
Other approvals
Rapid assessments of medicines containing new organisms

If you are interested in marketing a medicine in other countries, the relevant national regulatory agencies have guidance material. The Australian Therapeutic Goods Administration has regulatory guidelines for prescription medicines, over-the-counter medicines, complementary medicines and medical devices. The European medicines agency also has a range of guidance material. The US Food and Drug Administration has guidelines for drugs, biologics (eg vaccines and blood products), and medical devices.

In New Zealand the regulatory process depends on the type of medicine and whether clinical trials are required. Most medicines are imported into New Zealand rather than being developed here, and most will not require clinical trials to be undertaken in New Zealand.

Marketing a new medicine

Consent to market a new medicine requires an application to be made to Medsafe, which is a section of the Ministry of Health.

An application requires information on how the medicine is made, potential adverse effects (or lack of) of the medicine, and data on the safety and effectiveness when the medicine is used in humans. These information requirements are identical to data required by the Australian and European Union medicines safety authorities.

A product is evaluated with respect to its active ingredient(s), other ingredients it contains, its container or delivery system, how and where it is made and how safety, quality and efficacy of the medicine are affected by storage, prescription and use. The process undertaken by Medsafe is consistent with the evaluation processes of countries such as Australia, the United Kingdom and the USA.

Medsafe/MAAC Assessment

Innovator medicines are evaluated by the Medicines Assessment Advisory Committee (MAAC). MAAC is a committee of clinicians and other specialists appointed by the Minister of Health. For non-generic medicines members of MAAC evaluate the available information, consider whether the application meets Medsafe's guidelines and then make a recommendation to the Minister of Health on whether the medicine should or should not be granted consent to market.

Generic medicines and over-the-counter medicines are evaluated by Medsafe staff. Generic medicines do not need to provide clinical data for effectiveness, but they do need to demonstrate that they are chemically and metabolically similar to the original medicine they are copying. Data supporting bioequivalence with the original medicine may be accepted instead of clinical trial data, but you need to discuss this with Medsafe. Most over-the-counter medicines do not need to provide additional data on safety and effectiveness.

Minister of Health Approval

After evaluation MAAC or Medsafe makes a recommendation to the Minister of Health (or someone delegated by the Minister to make such decisions). The Minister then decides whether or not to approve the medicine. Notification of the consent is published in the "New Zealand Gazette", and the medicine can then be marketed.

Where a new medicine does not have complete information on safety, there is the possibility that a provisional consent could be given to use the medicine if there is an urgent clinical need and the potential benefit exceeds the risk of non-treatment. Contact Medsafe for more information on this.

Clinical Trials

Before a new innovator medicine or new combination can be marketed a series of tests or trials on humans must be conducted to establish the safety and effectiveness of the medicine. If such clinical trials are to be undertaken in New Zealand this requires an exemption under the Medicines Act. Clinical trials require independent evaluation of their scientific validity and ethical conduct before they can be undertaken. The committees involved in these assessments are described below. Recommendations from these committees are given to the Director-General of Health (or someone delegated by the Director-General to make the decision), who decides whether or not to approve the clinical trial. General information on clinical trials is available in the Glossary. Guidelines on good clinical research practice are available from Medsafe's website.

Note that clinical trials refer to tests on humans. Before testing on humans pre-clinical trials on animals will usually be necessary. You can discuss the requirements for pre-clinical trials with Medsafe or the Health Research Council.

Assessment by the Standing Committee On Therapeutic Trials (SCOTT)

Scientific assessment of clinical trials is undertaken by the SCOTT. SCOTT is a standing committee of the Health Research Council and consists of specialists from a range of health fields. This committee must evaluate proposals to:

Assessment by the Gene Technology Advisory Committee (GTAC)

Studies involving the introduction of nucleic acids (DNA or RNA), genetically manipulated micro-organisms, or viruses or cells into human subjects are referred to the GTAC for evaluation rather than to SCOTT.

GTAC consists of members with experience in such techniques (as well as a member of SCOTT) who provide a scientific assessment of this aspect of the proposed trial. Their assessment extends that which would have been conducted by SCOTT. For example, if a trial proposed to introduce encapsulated pig cells into diabetic humans, GTAC would assess the trial with respect to the safety and efficacy of using the pig cells, including the safety, efficacy and other factors associated with how the cells were encapsulated and introduced and the selection criteria for trial participants.

An evaluation by GTAC is required before an evaluation by an ethics committee. In New Zealand so far few clinical trials have involved genetic modification or xenotransplantation. Note that xenotransplatation is currently a restricted procedure under the Medicines Act, requiring the approval of the Minister of Health.

The HRC has guidelines on ethical considerations relating to research in human genetics [12 pages, 45Kb, PDF]. Contact Medsafe or the HRC for more information on what is required for applications to SCOTT and GTAC.

Assessment by a Human Ethics Committee

In addition to assessments by SCOTT and GTAC, any clinical trial must be assessed by a health and disability ethics committee. Health and disability ethics committees are accredited by the Health Research Council (HRC). These committees consider whether the trial meets ethical guidelines [53 pages, 365Kb, PDF], such as how people are selected for the trial and whether they are provided with enough information to be able to make an informed decision.

Regional health and disability ethics committees evaluate research that is to be carried out in their region. A multi-region ethics committee undertakes the assessment if the trial is conducted in more than one ethics committee region or nationally. Where the opinion of an ethics committee is disputed by the applicant a second opinion can be sought from the HRC ethics committee [2 pages, 12Kb, PDF]. Where an applicant continues to disagree with the opinion of their ethics committee, they can seek a final determination on the matter from the Sub-Committee on Appeals, a sub-committee of the National Ethics Advisory Committee established by the Minister of Health.

More information can also be found in the Human ethics section of the Regulatory Wayfinder.

How can I find out about decisions?

Regulatory updates are provided on Medsafe's website. You can also register on the website to receive e-mails advising you of new regulatory information and decisions. Decisions made by ERMA (see below) are provided on their website, and you can also register with them to receive information about publicly notified applications.

Other Approvals

New medicines involving "new organisms" or "hazardous substances"

Before a new medicine is ready for clinical use it may be subject to other regulatory approval in New Zealand. These additional approvals relate to approval to import, develop or release a "new organism" or import or manufacture a "hazardous substance". See the New organisms section of the Regulatory Wayfinder for more information on the regulation of hazardous substances. To find out more about whether a particular compound or medicine may also involve a hazardous substance or a new organism talk to ERMA NZ or Medsafe.

To test or release a new medicine in New Zealand that is or contains a new organism or hazardous substance then a HSNO Act approval for the medicine is required before consent is given to trial or market the medicine. The HSNO Act assesses risks to the environment as well as to human health. Applications for a HSNO Act approval need to be made to the Environmental Risk Management Authority (ERMA NZ).

Depending on the nature of the new organism this release approval may require either an application for a notified conditional release approval or it may be eligible for a rapid assessment. An application for conditional release requires detailed information and assessment of potential risks and benefits to human health and the environment, and would probably be publicly notified. See the section on Conditional Release in the New organisms regulatory process section of the Regulatory Wayfinder.

Rapid assessments of medicines containing new organisms

In some cases where approvals under both the HSNO Act and the Medicines Acts are required it may be possible to have a rapid assessment of environmental effects. Where a medicine is, or contains, a new organism and is considered to present a low risk to humans and the environment then it may be considered a "qualifying medicine" and be able to undergo a rapid assessment for release under the HSNO Act. This rapid assessment route is to reduce duplication between the HSNO Act and Medicines Act regulatory processes.

Such rapid assessments are only for medicines that are considered to be "low risk", meaning that they are very unlikely to have significant adverse effects on human health, any valued species or the environment. An example of a medicine that could qualify for rapid HSNO Act assessment would be a genetically modified vaccine that is not toxic or infectious.

Rapid assessments require a decision under the HSNO Act to be made within 40 working days of receipt of the application, and as such would not be publicly notified. Currently a decision on a rapid assessment application of a medicine can be made by the Chief Executive of ERMA NZ. There is the potential for the Director-General of Health to also seek to make such decisions, but a request to ERMA NZ to do so has not yet been made so that applications must currently be made to ERMA NZ. Regardless of who makes the decision, the information requirements and basis for making a decision will be the same.

While there may be a rapid assessment of potential environmental effects of a new organism, the Medsafe regulatory process and requirements for assessing the medicine's safety and effectiveness for humans is not changed.

An information sheet on qualifying medicines is available from ERMA NZ. To find out more about the rapid assessment process talk to ERMA NZ or Medsafe. If the medicine does not meet the qualifying medicine criteria an application for conditional release will need to be made to ERMA New Zealand (see the GMO section of this site).

MAF Import Permit

Importation of a new organism will also require an appropriate Import Permit from the Ministry of Agriculture & Forestry. See the New organisms section of this site for more information.

Animal Ethics Approval

If the research and development involves animals an approval from an accredited animal ethics committee is also required. See the Animal welfare section of this site.

Time and Cost

Time and costs associated with applications depend on the nature of the medicine and the strengths and doses. In addition, if a medicine requires HSNO Act approval there will be additional time and cost requirements. Note that processing times and fees may be subject to change so check with the relevant agencies for current timing and costings.

Evaluations by Medsafe or MAAC have set fees, with the fee depending on the nature of the medicine. Processing times also depend on the nature of the application. Typically, an application for an innovator medicine will cost a minimum of $15,300 and take up to 300 working days to process. Other types of assessments can cost less and take as little as 40 working days to process. Contact Medsafe for more information.

For a conditional release approval given under the HSNO Act there are no set fees, but ERMA NZ will provide a fixed cost quote on a case-by-case basis before an application is considered. The statutory processing time for a conditional release application is 100 working days, with the application fee negotiated. A rapid assessment application for release of a qualifying medicine under the HSNO Act costs $500 and processing takes 40 working days. For more information contact ERMA NZ.

GTAC and SCOTT have a standard fee of $9,843 (payable to Medsafe) for an assessment, and the evaluation process usually takes less than 20 days. Applications for exemptions to part of this fee can be made if the research is funded from New Zealand government sources. Contact the HRC to find out more about exemptions.

Assessment by a human ethics committee does not have an application fee, committees generally meet monthly, and most local applications will be considered within 60 days.

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