How Medicines are Regulated
Medsafe is responsible for ensuring that, as far as possible, the medicines available in New Zealand can be expected to have greater benefits than risks if used appropriately. This is achieved through:
- assessing the safety, quality and efficacy of medicines before they are marketed;
- auditing manufacturers, packers and wholesalers of medicines to ensure their premises and practices meet an acceptable standard
- monitoring the safety of medicines on the market.
Pre-marketing approval
- New medicines
- Changed medicines
Post-marketing surveillance
Multi-source (generic) medicines
- Why do we have multi-source medicines?
- Are multi-source medicines safe?
Pre-marketing approval
New medicines
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 delegate) to distribute a "new medicine". Such medicines fall into three categories:
- Innovator medicines that contain new active substances or are
administered in a novel way.
To obtain consent, the company must submit an application dossier containing detailed information about the safety, quality and efficacy of the medicine. The application is considered by the Medicines Assessment Advisory Committee, which is a committee of experts set up to advise the Minister of Health. - Multi-source or generic medicines that don’t have new
active substances or novel dose forms, but are a different brand from the
previously approved product.
To obtain consent to market the new brand, the company must submit an abridged application dossier that contains information about the safety, quality and efficacy of the new medicine for assessment by Medsafe evaluators. - Over-the-counter medicines that contain active ingredients with a
well-established record of use. These may be new products containing active
ingredients in different combinations, or new brands of previously approved
over-the-counter medicines.
To obtain consent to market a new over-the-counter medicine, the company must submit an abridged application dossier for assessment by Medsafe evaluators.
If an application for consent to market a new medicine is acceptable, the Minister of Health or his delegate approves the medicine. Notification of the consent is published in the New Zealand Gazette, and the medicine can then be marketed. The consent applies only to a single brand of the medicine made by a particular manufacturer.
Changed medicines
When an approved medicine undergoes a change (e g. the medicine is reformulated or the manufacturing process changes) the company marketing the medicine must obtain the consent of the Director-General of Health before the "changed medicine" can be marketed.
To obtain consent for the change, the company must submit information about the change for assessment by Medsafe evaluators. If the change is acceptable, the company will be notified and the changed medicine can then be marketed.
Post-marketing surveillance
Medsafe monitors the safety of medicines and medical devices in use in New Zealand. This is achieved by:
- monitoring adverse reactions to medicines used in New Zealand;
- testing marketed medicines against product quality standards;
- handling complaints and investigations; and
- auditing and licensing medicine manufacturers, pharmacies, etc.
Multi-source (generic) medicines
Some pharmaceutical companies invent new medicines, that may or may not be novel, and these are called innovator medicines. This developmental process involves considerable time and money, and companies usually take out a patent on their medicine to protect their investment. When the patent expires, other pharmaceutical companies can make copies of the innovator medicine. These copies are termed multi-source or generic medicines. A multi-source medicine contains the same active ingredient, at the same strength, and in the same form (for example tablets, syrups, etc.) as the innovator medicine. Pharmaceutical companies wishing to market multi-source products must provide information to Medsafe to show that their medicine has the same effect on the body as the innovator medicine.
Why do we have multi-source medicines?
If a company has not had to invest large sums of money to research and develop a new medicine, they can produce a product at less cost than the innovator company. This means cheaper medicines for the country, and in some cases, lower costs for the patient.
Are multi-source medicines safe?
Multi-source medicines undergo a rigorous assessment process before they can be marketed in New Zealand, similar to that applied to other new medicines. This assessment is carried out by Medsafe evaluators to international standards. Multi-source products can, therefore, be expected to be of the same quality, and as safe and effective as their innovator counterparts.