Acronyms & glossary of terms used on this website
25 November 2012
The following terms, definitions & acronyms are used in Australian therapeutic goods regulation. They are provided as general information only and this is not intended to be an exhaustive list.
Refer to Australian therapeutic goods legislation for legal definitions and for other terms not included on this page.
A-B
Agency - This refers to the proposed trans-Tasman therapeutic products regulator and, 'Agency' covers also 'Authority' and 'Regulator'.
ANZTPA - Australia New Zealand Therapeutic Products Agency - the joint regulatory agency.
ANZTPA Project - The project work to establish the joint regulatory agency.
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.
Board - A group of people appointed by the Ministerial Council to oversee the governance of the joint regulatory agency
Business-to-Business (B2B) projects - Projects undertaken by TGA and Medsafe in order to build consistency in business processes prior to the implementation of ANZTPA.
C
Classification - Also known as Scheduling. Recommendations made on the most appropriate level of access to medicines, e.g. only on prescription, over the counter in pharmacies, or unrestricted. The higher the risks associated with the medicine, the greater the restriction on access.
Closer Economic Relations (CER) - The policy that seeks to reduce and eliminate trade barriers between Australia and New Zealand, first implemented in 1982.
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.
Complementary Healthcare Products - This term was coined during the last review of the New Zealand Medicines Act 1981 and has been replaced with Natural Health Products.
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 activities are funded by fees and charges paid by industry users of services
D-F
DAEN - Database of Adverse Events - Australia only information. Part of JAENS.
Dietary Supplements - The current term for herbs, 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.
FDA - Food and Drug Administration [USA]
G-I
Gazette - The official newspaper of the respective Governments in Australia, and in New Zealand.
Good Manufacturing Practice (GMP) - A quality assurance system for the manufacture of therapeutic products 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.
Intellectual property - A legal term referring to ownership of ideas and applications including, for example, trademarks, patents, and copyrights.
Interim Ministerial Council - A group of senior ministers from the Australian and New Zealand governments responsible for oversight of the establishment of the Agency
J-L
Joint Adverse Event Notifications System(JAENS) - An online database that contains information about reports of suspected adverse events (also known as adverse reactions) to medicines that have been reported to the TGA and Medsafe.
Joint Therapeutics Agency (JTA) - A term for the agency that has now been superseded by the Australia New Zealand Therapeutic Products Agency (ANZTPA).
M
MAF - The former Ministry of Agriculture and Forestry in New Zealand - now part of the Ministry for Primary Industries.
Managing Director (MD) - The term for the head of the agency.
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 Online Recalls Database (MORD) - An on-line database that you can use to find information about medical devices or medicines that have been recalled in New Zealand.
Medsafe - The current New Zealand therapeutic products regulator. Medsafe is a business unit of the Ministry of Health.
Ministerial Council - The high level ANZTPA governance group consisting of the Australian and New Zealand Ministers of Health.
Mutual Recognition Agreement - Where, in a therapeutic products 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 Interest Analysis - An analysis that examines the reasons, the means, the implications, and the desirability for a country to sign a treaty with another country.
Natural Health Products - A general term for herbal, vitamin, mineral (etc.) dietary supplement products, currently used in draft New Zealand legislation. See Complementary Healthcare Products.
Pharmacovigilance - The collection and analysis of information on adverse reactions to medicines and other therapeutic products.
Pre-Market Evaluation - Evaluation of quality, safety and efficacy of new and changed therapeutic products.
Post-Market Surveillance - Monitoring of the safety of therapeutic products after they have been approved or otherwise released on the market.
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 level of access to medicines, e.g. only on prescription, over the counter in pharmacies, or unrestricted. The higher the risks associated with the medicine, the greater the restriction on access.
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 Australian and New Zealand Therapeutic Products Agency.
SMARS - Suspected Medicine Adverse Reaction Search - New Zealand only information on adverse reactions to medicines.
Statement of Intent - A commitment by the Prime Ministers of Australia and New Zealand to a program of work to develop a joint regulatory scheme and a joint therapeutic products regulator.
Statutory Office Holder - This term has been superseded by Managing Director.
Treaty - An agreement between the governments of Australia and New Zealand for the establishment of a joint scheme for the regulation of therapeutic products. The agreement was signed on 10 December 2003.
Therapeutic goods - This is the term currently used by the Therapeutic Goods Administration to refer to medicines, medical devices and what are variously called complementary medicines/dietary supplements/healthcare products.
Therapeutic Goods Administration (TGA) - The current Australian therapeutic goods regulator.
Transition Agency - A virtual agency set up by Australia and New Zealand to manage the project to establish the Australia New Zealand Therapeutic Products 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 permanent exemption from the free trade provisions of the TTMRA.
Trans Tasman Senior Officials Group (TTSOG) - A key governance group consisting of high level officials from relevant Australian and New Zealand government agencies.
U-Z
Unilateral Recognition - A mechanism whereby one country accepts the regulatory outcomes of another country without conducting evaluations itself.
Content last updated: Monday, 26 November 2012
Content last reviewed: Monday, 26 November 2012
Web page last updated: Monday, 15 April 2013
URL: http://www.anztpa.org/acronyms.htm