Glossary of terms used on this website
The following are terms that appear on this website, or are found in the documents available from this website. Some terms have changed over the course of this project as decisions have been made or more specific terms have been required. This glossary is intended to help you understand what is meant by each term to ensure consistency. It will be added to and amended as more aspects of the agency are developed.
A-B | C | D-F | G-I | J-L | M | N-Q | R-T | U-Z
A-B
- Agency
This refers to the proposed trans-Tasman therapeutic goods regulator and, 'Agency' covers also 'Authority' and 'Regulator'. - Australian Register of Therapeutic Goods (ARTG)
The Goods are entered on the Register as registered or listed goods. Registered goods are evaluated for quality, safety and efficacy. Listed goods are entered on certification by the applicant that they meet certain standards.
C
- CEO
Chief Executive Officer (for the agency). It is now proposed that the head of the agency will be called a Managing Director rather than CEO. - Classification
Also known as Scheduling. Recommendations made on the most appropriate means of supplying medicines to consumers, e.g. under a doctor's prescription, over the counter in pharmacies, or from supermarkets. The higher the risks associated with the medicine, the more its supply is restricted. - Closer Economic Relations (CER)
The policy that seeks to reduce and eliminate trade barriers between Australia and New Zealand. - COAG Principles of Good Regulatory Practice [Australia] / Code of Good Regulatory Practice [New Zealand]
A set of principles that provides a general framework for regulatory policies based on the following principles:- Efficiency;
- Effectiveness;
- Transparency of decision-making;
- Clarity, and
- Equity.
The Code of Good Regulatory Practice can be found on the Internet site of the New Zealand Ministry of Economic Development. - Complementary Healthcare Products
A general term for herbal, vitamin, mineral (etc) dietary supplement products. This term was coined during the last review of the New Zealand Medicines Act 1981. - Complementary medicines
The Australian term for those therapeutic goods which, because they have a traditional health care use and contain certain active ingredients, are regulated in Australia under the Therapeutic Goods Act 1989. They include herbal, vitamin, mineral and homeopathic products (etc) products. Most products that fall into this category are regulated in New Zealand under the Dietary Supplements Regulations 1984. - Cost Recovery
Where the agency is fully funded from administrative fees levied on industry.
D-F
- Dietary Supplements
The current term for herbal remedies, vitamins, minerals etc in pharmaceutical form in New Zealand. They are regulated under the Dietary Supplements Regulations 1984 under the Food Act 1981. Many of these products are regulated as complementary medicines in Australia under the Therapeutic Goods Act 1989.
- Executive Committee
This term has been replaced by the 'Board'.
- FDA
Food and Drug Administration [USA]
G-I
- Gazette
The official newspaper of the Government, respectively in Australia, and in New Zealand. - Good Manufacturing Practice (GMP)
A quality assurance system for the manufacture of therapeutic goods based on best international practice.
- Healthcare and Therapeutic Products Bill
A series of policy proposals developed in New Zealand to replace the Medicines Act 1981. It was never drafted and is now superseded by policy proposals to be developed for the trans-Tasman project.
- INCB
International Narcotics Control Board. The Board's responsibility is to promote government compliance with the provisions of the drug control treaties and to assist them in this effort. - Intellectual property
A legal term referring to ownership of ideas and applications, including for example trademarks, patents, and copyrights.
J-L
- Joint Therapeutics Agency (JTA)
A term for the agency that has now been superseded by the trans-Tasman Therapeutic Goods Regulatory Agency.
M
- MAF
Ministry of Agriculture and Forestry [New Zealand] - Managing Director (MD)
This is now the preferred term for the head of the agency, superseding Statutory Office Holder and Chief Executive Officer. - Medical devices/Therapeutic devices
These cover a wide range of products from surgical gloves and sutures through to complex products such as heart valves, pacemakers and artificial hips. They differ from medicines in that they do not achieve their effect by pharmacological, chemical, immunological or metabolic means. - Medicines
In general, the term covers a good that is administered for a therapeutic purpose. There are two different legislative terms, one in the Therapeutic Goods Act 1989 [Australia] and one in the Medicines Act 1981 [New Zealand]. - Medsafe
The current New Zealand therapeutic goods regulator. Medsafe is a business unit of the Ministry of Health. - Mutual Recognition Agreement
Where, in a therapeutic goods context, each country that is a party to an international agreement recognises another country's regulatory assessment and approval of a product.
N-Q
- National Registration Authority for Agricultural and Veterinary Chemicals (NRA)
The Australian statutory authority that approves chemical products for agricultural and veterinary use.
- Pharmac
The pharmaceutical purchasing agency of the New Zealand Government that negotiates pharmaceutical prices for the New Zealand market. - Pharmaceutical Benefits Scheme (PBS)
The Australian scheme for subsiding the cost to consumers of pharmaceuticals. - Pharmacovigilance
The collection and analysis of information on adverse reactions to therapeutic goods. - Pre-Market Evaluation
Evaluation of quality, safety and efficacy of new and changed therapeutic goods. - Post-Market Surveillance
Monitoring of the safety of therapeutic goods in use.
R-T
- Regulatory Impact Statement
A tool that assesses the impact of proposed government intervention. It is a formal requirement of both the Australian and New Zealand governments before a policy decision is made.
- Scheduling
Also known as Classification. Recommendations made on the most appropriate means of supplying medicines to consumers, e.g. under a doctor's prescription, over the counter in pharmacies, or from supermarkets. The higher the risks associated with the medicine, the more its supply is restricted. - Single Joint Agency (SJA)
The preferred option out of the four options presented in the Consultation Paper June 2000. Once this model was chosen, it has been variously referred to as the Joint Therapeutics Agency (JTA) and most recently the trans-Tasman Therapeutic Goods Regulatory Agency. - Statutory Office Holder
This term has been superseded by Managing Director.
- Therapeutic goods
This is the current preferred term by the Project Team to refer to medicines, medial devices and what are variously called complementary medicines/dietary supplements/healthcare products. 'Goods' is preferred over 'products' as it encompasses active ingredients that may not be 'produced'. The term does not apply to goods that are covered by a standard in the Australia New Zealand Foods Standards Code. - Therapeutic Goods Administration (TGA)
The current Australian therapeutic goods regulator. - Trans-Tasman Agency Project Team
A group of officials from Medsafe and the Therapeutic Goods Administration involved in developing proposals for the trans-Tasman agency. - Trans-Tasman Mutual Recognition Arrangement (TTMRA)
This details the arrangements for various sectors to implement the closer economic relations policy to reduce trade barriers between New Zealand and Australia. Therapeutic goods have a temporary exemption from the free trade provisions of the TTMRA. - TTT IDC
The trans-Tasman Therapeutics Interdepartmental Committee. This is a group of senior officials from Government departments from Australia and New Zealand who oversee the work of the Project Team.
U-Z
- Unilateral Recognition
A mechanism whereby one country accepts the regulatory outcomes of another country without conducting evaluations itself.