Revised: 12 September 2019
Medicines
Medsafe's Evaluation and Approval Process
How are medicines approved in New Zealand?
How can I know that a medicine has been
approved for sale in New Zealand?
What is the medicine evaluation process?
How long does this process take?
What data does Medsafe review in medicine
applications?
What are the criteria used by Medsafe to
establish the quality of a medicine?
How is the efficacy of a medicine established
before it can be approved?
How is the safety of a medicine established before
it is approved for use in New Zealand?
How are medicines approved in New Zealand?
Companies who wish to sell a new medicine in New Zealand make an application to Medsafe (called a New Medicine Application or NMA). This application includes information that demonstrates the medicine meets New Zealand and internationally recognised standards for quality, safety and efficacy.
Medsafe reviews this information and makes a recommendation to the Minister as to whether the medicine is approvable, or otherwise. If the medicine is approved, the New Zealand sponsor company then decides if the medicine will be supplied in this country.
Companies also submit notifications to Medsafe for planned material changes to an approved medicine (called a Changed Medicine Notification or CMN). Medsafe evaluates the change(s) to ensure that it does not affect the established quality, safety and efficacy of a registered medicine. Changed medicines cannot be marketed without the consent of the Director-General of Health (or delegate).
Medsafe is not responsible for funding or purchasing medicines in New Zealand. The government organisation responsible for determining which medicines will be publicly funded is PHARMAC.
How can I know that a medicine has been approved for sale in New Zealand?
Medsafe lists all medicines that have been approved in New Zealand on its website, and any medicines where an application was submitted but approval was not granted.
This list includes information on where the medicine is made, the ingredients it contains, how it is packaged, what it is used for (indications) and who is legally responsible for the product (known as the Sponsor).
This information can be found on the Product/Application Search page.
What is the medicine evaluation process?
An application to approve a new medicine includes data supporting the medicine's quality, safety and efficacy.
An evaluation of the New Medicine Application is undertaken. If Medsafe considers the information to be inadequate it will request further information. Medsafe then reviews the response and makes a decision as to whether or not it can recommend to the Minister of Health that the medicine be granted consent to be marketed in New Zealand.
How long does this process take?
Medsafe aims to complete the various stages of a New Medicine Application evaluation within target time frames. There are also statutory timelines for the evaluation of Changed Medicine Notifications. The total time taken to reach a final decision can vary, and depends on the amount and complexity of the information provided, the amount of additional information requested and how long it takes the company to respond to Medsafe's requests for more information.
Information on Medsafe’s evaluation timelines.
What data does Medsafe review in medicine applications?
- The acceptability of the proposed product trade name.
- Evidence of Good manufacturing practice (GMP) to demonstrate the medicines are consistently manufactured under acceptable quality standards.
- Chemical and biological data that supports the source, manufacture, characterisation, quantity, quality, storage and stability of the drug substance (active ingredient) and drug product (finished product).
- The quantity and quality of other non-active ingredients (excipients) present in the medicine.
- The formulation of the medicine (eg, tablet, suspension, capsule, injection).
- Agreed specifications (quality tests) that the medicine must meet before it is released to be sold or dispensed.
- Results of bioequivalence studies that evaluate the therapeutic equivalency of generic medicines and the corresponding brand name (innovator) products.
- Results of clinical studies in people that demonstrate new medicines are safe and effective for the treatment of a particular disease or condition.
- The quality of the medicine's packaging and the content of the medicine label.
- The information presented in the medicine data sheet and package insert (eg, consumer medicine information (CMI)).
What are the criteria used by Medsafe to establish the quality of a medicine?
Medsafe assesses medicine applications against internationally established criteria, such as guidelines published by the EMA (European authority), the FDA (USA), Health Canada, the TGA (Australia) and the International Conference on Harmonisation (ICH).
Medsafe does not test every medicine before it is approved. The assessment of a medicine application is based on information supplied to Medsafe. Manufacturers are regularly inspected by Medsafe or other international regulators to ensure they consistently produce high quality medicines.
All medicines, regardless of the country of manufacture, are assessed to the same requirements.
How is the efficacy of a medicine established before it can be approved?
Efficacy is a technical term used to describe how well the medicine works.
Clinical trials are undertaken by pharmaceutical companies to collect data on the efficacy of potential new medicines. These trials can be conducted using healthy volunteers or patients, depending on the type of medicine and its stage of development.
Clinical trials begin with small studies in a controlled population of volunteers or patients and, as data are gathered, expand to large scale studies in patients. These large scale studies investigate the new medicine in comparison with placebo or another established treatment.
Bioequivalence studies are designed to compare the rate and extent of absorption of the active ingredient(s) in a test generic medicine with that of a reference innovative medicine. If two medicines are demonstrated to be bioequivalent, it is considered that there would be no clinically significant difference in their bioavailability, and their efficacy and safety profiles are therefore considered to be the same. As a result, it would not normally be necessary to repeat clinical studies for generic medicines.
How is the safety of a medicine established before it is approved for use in New Zealand?
The pharmaceutical company responsible for that medicine provides Medsafe with safety information from clinical studies performed using that medicine. If the medicine has also been supplied elsewhere the company will also provide data from use in that country. The extent of the clinical studies varies depending on the type of medicine application.
Medsafe evaluates the results from these clinical studies to determine if the safety profile is acceptable.
Medsafe reviews the risks and benefits for each specific medicine to ensure that the safety profile is acceptable (ie, the benefits of the medicine outweigh the risks).
The following factors are taken into consideration.
- Benefits
- Has efficacy been demonstrated in the target population (ie, those who will use the medicine)?
- Is the medicine significantly better than a placebo?
- How does the medicine compare to any alternative treatments?
- How many people have the condition that this medicine will treat or prevent?
- What is the natural history of the disease?
- Is it self-limiting, chronic or fatal?
- Risks
- What proportion of people taking the medicine experience an adverse reaction?
- How many of these adverse reactions are considered to be serious?
- How many people stopped treatment because of an adverse reaction?
- Are the adverse reactions reversible, treatable or avoidable (eg, interactions with other medicines)?
