Revised: 4 July 2013

Safety Information

Medsafe's Evaluation and Approval Process

How are medicines approved in New Zealand?

Companies who wish to sell a medicine in New Zealand make an application to Medsafe. This application includes information that demonstrates the medicine meets recognised standards for quality, safety and efficacy that New Zealand expects and/or international standards.

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.

Medsafe is not responsible for funding or purchasing medicines in New Zealand. Please note that 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 now 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 and and who is legally responsible for the product (known as the Sponsor).

This information can be found at 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 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 Minster of Health that the medicine be approved.

How long does this process take?

Medsafe aims to complete its initial evaluation within 200 calendar days of receipt of the application. The total time taken to reach a final decision can vary and depends on the amount and complexity of the information provided and how long it takes the company to respond to Medsafe's requests for more information.

What data does Medsafe review in medicine applications?

Companies provide data to demonstrate that they meet the standards expected. Data includes evidence that the medicine is manufactured using a controlled process, the medicine treats the medical conditions claimed and the ingredients comply with internationally established standards.

Medsafe evaluates the following information:

  • The source, manufacture, quantity and quality of the active ingredient (drug substance).
  • The quantity and quality of the other non-active ingredients (excipients or fillers).
  • The formulation of the medicine e.g. tablet, suspension, capsule, injection.
  • How the medicine is made and proof that the process consistently produces a high quality medicine.
  • Agreed specifications (quality tests) that the medicine must meet before it is released to be sold or dispensed.
  • Proof that the pharmaceutical company can test the quality of the medicine accurately.
  • The quality of the medicine's packaging and the content of the medicine label.
  • Proof that the medicine does not degrade quickly (ie "go off" too quickly).
  • Results of clinical studies in people that provide information on whether the medicine works (efficacy) and the medicine's safety profile.

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, and the International Conference on Harmonisation (ICH).

Medsafe does not test every medicine itself 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 quality medicines.

All medicines, regardless of 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.

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:

  1. Benefits:
    • Has efficiacy been demonstrated in the target population (ie those who will use the medicine)?
    • Is the medicine significantly better than placebo (dummy treatment)?
    • 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?
  2. 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)?
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