What are therapeutic products and how would they be regulated under the proposed joint scheme?
Australia and New Zealand – working together to safeguard public health and safety both now and into the future
Fact sheet
January 2007
What are therapeutic products and why do we need to regulate them?
Therapeutic products include complementary medicines such as most dietary supplements and herbal medicines; over-the-counter medicines and prescription medicines; medical devices such as contact lenses, condoms, hearing aids, heart valves, pace makers and endoscopes. Blood and blood products, and cellular and tissue therapies are also examples of therapeutic products.
It is important to regulate pre and post market safety, quality and effectiveness of these products so that consumers are assured that their health and safety is safeguarded.
What are the key objectives of the proposed joint regulatory scheme?
The primary objective of the proposed joint regulatory scheme is to safeguard the health and safety of Australians and New Zealanders who use and consume therapeutic products.
The proposed regulatory scheme would achieve this through:
- Setting standards for therapeutic products;
- Pre-market assessment of therapeutic products to assure product safety, quality and effectiveness or performance;
- Licensing of manufacturers to assure product quality; and
- Post-market surveillance to check for compliance.
The manner and extent of regulation will depend on the type of product and the level of risk associated with its use. The lower the risk, the lighter the regulatory controls.
What are the proposed risk classes for therapeutic products?
It is proposed that therapeutic products will be divided into risk classes according to the level of risk associated with their use. The level of regulatory controls will depend on the risk associated with the medicine or medical device.
Most complementary medicines are expected to be classified as low-risk medicines (Class 1). Higher-risk medicines will include most over-the-counter and all prescription medicines (Class 2).
Medical devices will also be divided into risk classes consistent with the international approach to the regulation of medical devices.
Will therapeutic products have to undergo pre-market assessment before gaining an ANZTPA product licence?
Yes. An applicant wishing to supply a medicine or medical device will be required to hold a product licence. A product licence will authorise the supply of that product in both New Zealand and Australia, subject to the conditions on the licence. The application requirements and the assessment processes applied to applications will be different for different risk classes and for different types of products within a risk class.
For low-risk medicines and medical devices, applicants will be required to enter information into a web-based system, providing details about the product, declaring that the product meet certain standards and certifying that they hold the necessary information or documentation to support their declaration. Low-risk medicines that are self-certified in this way will only be allowed to contain ingredients from a "permitted ingredients list" and there will be restrictions on the therapeutic claims that can be made for this class of medicine. The on-line system will validate the information entered in the application against the rules and restrictions set by the Authority for ensuring that the product is low risk.
For higher-risk medicines and medical devices, the applicant will be required to submit a product licence application for evaluation by the Authority. The application requirements and the type and level of evidence required will vary depending on the type of product and the degree of risk.
Will there be any product licence exemptions?
Yes. There will be certain exemptions from the requirement to hold a product licence, for example, where therapeutic products are used in clinical trials, imported for personal use or made by a practitioner for an individual patient such as a pharmacist, herbalist, traditional Chinese medicine practitioner, or traditional Maori healer.
Will manufacturers of therapeutic products have to assure product quality?
Yes. Manufacturers of medicines and medical devices will be required to meet appropriate quality standards or good manufacturing practice (GMP) standards and will be audited and licensed to ensure compliance.
Will there be post-market monitoring of product safety and quality, to check for compliance?
Yes, there will be post-market monitoring of adverse reactions to medicines, incident reporting for medical devices, and product testing to check for compliance with product quality standards. In the event of a serious safety concern, a product licence may be suspended or revoked or a therapeutic product recalled from the market place.
URL: http://www.anztpa.org/about/fs-regulation.htm