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Here are the definitions to some common industry terms
A
-ECTOMY
This is the end of a word. It means taking away by surgery. An "appendectomy" is surgery to take out your appendix.
GENESIS
This is part of a word. When used at the end of a word, it means producing. Pathogenesis means disease-producing.
-ITIS
This is part of a word. It means swelling. Swelling can be caused by a wound, break, or infection in your body.
Tonsillitis means swelling of the tonsils. Signs of swelling are redness, pain, or heat.
-OMA
This is part of a word. It means a large bunch of cells. It is in lymphoma. This is cancer where white blood cells grow faster than they should and make a tumor.
-OSIS
This is part of a word. It comes at the end of a word. It means that something is not normal. Trichinosis means having a worm in your stomach, gut, or muscles.
AAN
Australian Approved Name
AAT
Administrative Appeals Tribunal
ABSCESS
This word means pus formed in the body to fight germs that cause infection.
ABN
Australian Business Number or Approved Biological Name
ACB
Advisory Committee on Biologicals
ACCM
Advisory Committee on Complementary Medicines
ACCS
Advisory Committee on Chemicals Scheduling
ACM
Advisory Committee on Medicines
ACMD
Advisory Committee on Medical Devices
ACMS
Advisory Committee on Medicines Scheduling
ACN
Australian Cell and Tissue Name
Act [the]
The Therapeutic Goods Act 1989
Active implantable medical device (AIMD)
An active medical device (other than an implantable medical device) that is intended by the manufacturer:
a. either:
i. to be, by surgical or medical intervention, introduced wholly, or partially, into the body of a human being; or
ii. to be, by medical intervention, introduced into a natural orifice in the body of a human being; and
b. to remain in place after the procedure.
Active ingredient
The therapeutically active component in a medicine's final formulation that is responsible for its physiological action
Active medical device
a). A medical device that is intended by the manufacturer:
i. to depend for its operation on a source of electrical energy or other source of energy (other than a source of energy generated directly by a human being or gravity); and
ii. to act by converting this energy; but
b). does not include a medical device that is intended by the manufacturer to transmit energy, a substance, or any other element, between an active medical device and a human being without any significant change in the energy, substance or other element being transmitted
Active pharmaceutical ingredient (API)
Means any substance or mixture of substances intended to be used in the manufacture of a medicine and that, when used in the production of a medicine, becomes an active ingredient of that medicine. These substances are intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure and function of the body. Defined in Therapeutic Goods (Manufacturing Principles) Determination 2018 .
Active raw material
The unformulated active chemical substance, usually a powder or a liquid, in the form in which it is used to manufacture a dosage form, usually in combination with excipients
Active substance
Synonym and replacement for 'drug substance'; synonym for 'active pharmaceutical ingredient'.
Acute
This is a serious illness or injury. A doctor or nurse should take care of it right away.
ad effect
Until effective
ad lib
As much as desired
Adherence
This word means to carefully follow instructions. An example is taking the right amount of medicine at the right time.
Adipocyte
This is a kind of cell in the body. It stores energy as fat.
Adjunct
This is a drug or treatment that is used along with another drug or treatment to help it work better.
Adjuvant
A drug or other substance that enhances the activity of another.
(in immunology) A component that potentiates the immune response to an antigen and/or modulates it towards the desired immune response.
(in chemotherapy) The use of anticancer drugs after, or in combination with, another form of cancer treatment (e.g. after surgical removal of a cancer. The method is used where there is a significant risk that undetected cancer cells may still be present.
Adventitious agent safety
In the context of guidance about adventitious agent safety of medicines means:
The implementation of control processes to prevent adventitious agents entering therapeutic goods, or to reduce or inactivate adventitious agents that may be in the therapeutic goods during the manufacturing process. It applies to all medicines that contain, or are manufactured using, material of animal or human origin.
ADR
Adverse drug reaction
Agent
A person duly authorised in writing to act on behalf of the sponsor of the goods.
AHEC
Australian Health Ethics Committee
AHMAC
Australian Health Ministers' Advisory Council
AHN
Approved Herbal Name
AHS
Approved Herbal Substance Name
AIVC
Australian Influenza Vaccine Committee
ALARP
As low as reasonably practicable
Algia
This is part of a word. It means pain or ache. Myalgia means muscle pain.
Allergy
This is when the body overreacts to something that is usually harmless. Things like dust, animal hairs, food or plants may do this. If you are allergic to something, you may have runny eyes, coughing, or itching.
Analysis
Refers to 'includes examination and testing', as described by Regulation 2, Part 1(2) of the Therapeutic Goods Regulations 1990.
Antibiotic
In relation to guidance about drug master files and certificates of suitability means:
A selective antimicrobial agent, other than disinfectants, antiseptics and substances solely used as antineoplastics, that, on application to living tissue or by systemic administration, kills or prevents growth of susceptible micro-organisms.
Antibodies
These are proteins that the body makes to protect itself from bacteria and viruses.
Anticipated shortage
In relation to a medicine, means a shortage of the medicine that is anticipated to commence at a future date.
Antigen
This is something that triggers the body to fight infection. A vaccine is an example of an antigen.
Antiretrovial Therapy (ART) or Highly Active Antiretroviral Therapy or Treatment (HAART)
This is the combination of three or more medicines given to HIV patients to slow down HIV infection. These medicines can be called a "cocktail."
Antiseptic
A substance:
a. that is recommended by its manufacturer for:
i. dermal application; or
ii. application to the mucous membranes of a person or an animal:
A. to kill micro organisms; or
B. to prevent the growth of micro organisms to a level that causes or may cause clinical infection; and
C. that is not represented to be suitable for internal use.
ANZTPA
Australia New Zealand Therapeutic Products Authority
ap
ante prandium, before dinner
API
Active Pharmaceutical Ingredient(s)
Appellant
In the terms of the Therapeutic Goods Act 1989 – a person seeking a review of a decision under the provisions of Section 60C of the Therapeutic Goods Act 1989.
APVMA
Australian Pesticides and Veterinary Medicines Authority
aq
aqua, water
ARGATG
Australian Regulatory Guidelines for Advertising Therapeutic Goods
ARGCM
Australian Regulatory Guidelines for Complementary Medicines
ARGMD
Australian Regulatory Guidelines for Medical Devices
ARGOM
Australian Regulatory Guidelines for OTC Medicines
ARGPM
Australian Regulatory Guidelines for Prescription Medicines
ARPANSA
Australian Radiation Protection and Nuclear Safety Agency
ARTG
The Australian Register of Therapeutic Goods
ARTG entry
Refers to separate and distinct goods included in the Australian Register of Therapeutic Goods (ARTG), as described by the criteria in Section 16(1) of the Therapeutic Goods Act 1989. Grouped goods represent two or more ARTG entries under a single ARTG number.
ARTG purpose
Relates to the basis of the goods inclusion in the ARTG. Goods are included in the Register as a mechanism indicating approval for supply in Australia and/or approval for export from Australia. Goods for export only will have an ARTG purpose of 'export'; all others will have a purpose of supply'.
ARTG status
A term which describes the registration /listing status of therapeutic goods in relation to their inclusion, or otherwise, in the ARTG. It includes registered, listed, cancelled by Secretary and cancelled by sponsor.
ASMI
Australian Self Medication Industry
ASPIRATION
This means using a syringe or needle to take out fluid from a lump or cyst.
ATN
Additional trade name
AUST L number
The unique ARTG number for a listed therapeutic product
AUST R number
The unique ARTG number for a registered therapeutic product
Australian Approved Name (AAN) for pharmaceutical substances
A name for an ingredient, or a plant or other organism included in the formulation of a medicine, which is included in the list of TGA Approved Terminology for Medicines published by the Therapeutic Goods Administration. The list comprises three parts:
* Chemical substances AAN list;
* Herbal substances AAN list; and
* Biological substances AAN list.
Australian Register of Therapeutic Goods (ARTG)
Maintained under s. 9A of the Therapeutic Goods Act 1989 for the purpose of compiling information in relation to, and providing for evaluation of, therapeutic goods for use in humans.
Autograft
Living tissue transferred from one part of a patient's body to another
Autologous use
The use of blood, blood components, tissues and cellular therapy products that are removed from and applied to the same person
OR
The use of biologicals that are removed from and applied to the same person
B
Bacteria
These are tiny organisms found in dirt, water and air. Some of them are helpful, but others may make you sick.
Germs are bacteria.
Basal Metabolic Rate
This is a test that measures how much air you breathe and how much energy you spend. The test is done when you are resting quietly.
Batch
A quantity of a product that is:
a. uniform in composition, method of manufacture and probability of chemical or microbial contamination; and
b. made in one cycle of manufacture and, in the case of a product that is sterilised or freeze dried, sterilised or freeze dried in one cycle
B-Cells
These are a type of white blood cell. They help to fight infections and viruses.
BCS
Biopharmaceutic Classification System
B.I.D.
This means “two times a day.” An example is if you take your medicine once in the morning and once at night.
bid
bis en die, twice each day
Bioburden
The quantity and characteristics of microorganisms present in, or on therapeutic goods, or to which they may be exposed to during manufacturing.
Biological (noun)
A thing that comprises, contains, or is derived from human cells or tissues; or comprises or contains live animal cells, tissues or organs; and is represented in any way to be, or is likely to be, for therapeutic use.
Biopsy
This means taking out a small amount of body tissue to test or look at under a microscope to diagnose or find out what the problem is.
Blinding
Blinding (also called masking) is a procedure in which one or more parties in a clinical trial are kept unaware of the treatment assignment(s). Blinding is used so that neither the patients' nor staff's expectations about the medicine or treatment under investigation can influence the outcome.
Blood
Whole blood collected from a single human donor and processed either for transfusion or further manufacturing.
Brachi, Brachio
This is part of a word. It means something to do with the arm. For example, a brachial vein is a vein in your arm.
Brady
This is part of a word. It means slow. Bradycardia” means slow heartbeat.
Blood components
Means therapeutic components of blood (red cells, white cells, platelets, plasma) that can be prepared by centrifugation, filtration and freezing.
Broadcast media
In relation to an advertisement or generic information, means any means (other than a means declared in the regulations to be an exempted means) by which the information is disseminated electronically in a visible or audible form or a combination of such forms.
BSE
Bovine spongiform encephalopathy
Bulk product
Synonym for 'drug product'.
C
C of A
Certificate of Analysis - a certificate issued by the manufacturer of the product reporting the test results obtained for the specified lot(s) of product supplied.
CAS
Chemical Abstract Services
Case study
In depth description of the factors related to a disease, disorder or condition in a specific individual.
Category A patient
A person who is seriously ill with a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment.
Category B patient
All other patients that do not fit the Category A definition (see Special Access Scheme).
Cell culture A method for growing cells outside of the body. For example, to sustain a population, to increase the number of cells (‘expanding’) or promote the production of new cell types
Certificate of a Pharmaceutical Product (CPP)
For medicinal products, the issue of a certificate by the TGA under the World Health Organisation (WHO) Certification Scheme on the Quality of Pharmaceutical Products moving in International Commerce. It is issued only for therapeutic goods that are medicines. It allows the country of import to ascertain the product's marketing status in Australia and whether it has been manufactured in compliance with GMP.
Certificate of Suitability of a Monograph of the European Pharmacopoeia (CEP)
A certificate provided to the manufacturer by the European Directorate for the Quality of Medicines & HealthCare to certify that the relevant monograph in the European Pharmacopoeia adequately controls the substance as manufactured by the company at the time the certificate was granted.
Certified Product Details (CPD)
A statement of product details, specifications and test methods generated by the sponsor at the request of the TGA.
Chemically derived medicine
A medicine that contains an active ingredient that has been manufactured in whole, or in part, by chemical methods.
CHMP
Committee for Medicinal Products for Human Use
CI
Colour Index
CIOMS
Council for International Organizations of Medical Sciences
Client ID
Identification code assigned by the TGA to a client
Clinical significance
The quality of a study's outcome that convinces physicians to modify or maintain their current practice of medicine. The assessment of clinical significance is usually based on the size of the effect observed, the quality of the study that yielded the data, and the probability that the effect is a true one. Clinical significance is not the same as statistical significance; a finding in a study may demonstrate a statistical difference in an attribute under review but this may have no impact clinically.
Clinical trial (synonyms: clinical study, intervention study)
A planned study in humans of an intervention (including a medicine, treatment or diagnostic procedure) with the object of investigating safety or efficacy and designed to achieve at least one of the following:
*the discovery or verification of clinical, pharmacological or other pharmacodynamic effects
*the identification of adverse reactions or adverse effects
*the study of absorption, distribution, metabolism or excretion.
Closed shelf life
The shelf life of a therapeutic good before opening of the immediate container in which the therapeutic good is supplied.
CLP
Certificate of Listed Product
CMEC
Complementary Medicines Evaluation Committee (replaced in 2010 by the Advisory Committee on Complementary Medicines (ACCM))
Collection
In relation to blood, blood components: the process of removing human blood, blood components, cells or tissue from a donor.
In relation to biologicals: the process of removing a biological or a source of a biological from a donor.
Colour
In relation to colourings used in oral medicines means:
An inactive substance that is used in oral formulations of medicines, for various reasons (e.g. To distinguish between strengths, indications or markings).
Combined collection of evidence
Refers to the collection of evidence items to support a primary clinical study or primary item of evidence, and when taken together they address all overarching concepts raised in the checklists for a particular indication.
Competent valve
In relation to biologicals, a dissected valve that is capable of functioning in a defined effective manner.
Composite pack
A medicinal product where the primary pack or the container includes at least two kinds of medicinal products and does not contain any therapeutic devices. The medicinal products must be for use as a single treatment regimen. Examples include a strip or blister pack containing tablets or capsules with differing formulations to be taken in a specified order, or a primary pack containing an active ingredient in one vial and a diluent in another vial, or a primary pack containing separate containers of different formulations for use as part of a single regimen of treatment.
Composite pack [medicine]
A medicinal product where the primary pack or the container includes at least two kinds of medicinal products and does not contain any medical devices. The medicinal products must be for use as a single treatment or as a single course of treatment, and it is necessary that the medicines be combined before administration or that they must be administered in a particular sequence.
Examples:
*a strip or blister pack containing tablets or capsules with differing formulations to be taken in a specified order
*a primary pack containing an active ingredient in one vial and a diluent in another vial
*a primary pack containing separate containers of different formulations for use as part of a single regimen of treatment
Concurrent validation
Validation carried out during routine production of batches intended for supply.
Condition
In relation to a person, any deviation(s) from the normal structure or function of the body, as manifested by a characteristic set of signs and symptoms.
Consumer demand
In relation to a medicine, means the overall volume and timing needs of the consumer to access the medicine. For the purpose of medicine shortages, the assessment of the demand is limited to the availability to the overall Australian market and not the separate points of distribution.
Consumer goods
Goods intended for personal, domestic or household use.
Container
In relation to therapeutic goods, means the vessel, bottle, tube, ampoule, syringe, vial, sachet, strip pack, blister pack, wrapper, cover or other similar article that immediately covers the goods, but does not include an article intended for ingestion.
Container type
In relation to therapeutic goods, means the vessel, bottle, tube, ampoule, syringe, vial, sachet, strip pack, blister pack, wrapper, cover or other similar article that immediately covers the goods, but does not include an article intended for ingestion. Container types are independent of the material used to fabricate them.
Contract manufacture
Where all or part of the manufacturing process of therapeutic goods is carried out by a person other than the sponsor on a contract basis. Can include principal manufacturers and other (sub) manufacturers.
Control
In clinical trials comparing two or more interventions, a control is a person in the comparison group that does not receive the medicine or treatment under evaluation. Instead that person receives a placebo, no intervention, usual care or another form of care. In case-control studies, a control is a person in the comparison group without the disease or outcome of interest.
COPD
Chronic Obstructive Pulmonary Disease
Cord blood
Blood which contains many different types of cells, including stem cells, taken from the umbilical cord
CPMP
Committee for Proprietary Medicinal Products
Critical material
Means all materials or supplies used in the manufacture of therapeutic goods which could have a direct impact on the quality, safety or function of the final goods.
Critical medical device
A device that, when used as recommended by its manufacturer, is in a sterile condition on introduction into the human body.
Current shortage
In relation to a medicine, means a shortage of the medicine that has commenced and is ongoing.
Custom-made medical device
A medical device that:
a. is specifically made in accordance with a request by a health professional specifying the design characteristics or construction of the medical device; and
b. is intended to be used only in relation to a particular individual
Cytotoxic T Lymphocyte (CTL)
This is a T-cell that can find and break apart the cells that have a virus inside them.
CV
Curriculum vitae.
D
Data processing device
Any article or material (for example, a disc) from which information is capable of being reproduced with or without the aid of any other article or device.
Date of manufacture
For a biological: the date (day, month and year) on which the processing of the product, including the packaging, is completed.
dbl
double
Derm, Derma
This is part of a word. It means skin. A dermatologist is a skin doctor.
Diluent
In relation to stability testing for prescription medicines means:
A sterile liquid, supplied as a component of some medicines or as a separate product, and intended for use in reconstitution/dilution of the drug product in preparation for administration (e.g. water for injections).
Direct diagnosis
In relation to a patient, means continuous surveillance by direct measurement.
Directions for use
Includes information on:
a. appropriate uses of the therapeutic goods
b. the method of administration or use of the goods
c. the frequency and duration of treatment for each indication of the goods
d. the use of the goods by persons of particular ages or by persons having particular medical conditions
Disease
Any deviation or interruption of the normal structure or function of any part, organ or system (or combination thereof) of the body that is manifested by a characteristic set of symptoms and signs and whose aetiology, pathology and prognosis may be known or unknown.
Disinfectant
A substance:
a. that is recommended by its manufacturer for application to an inanimate object to kill micro-organisms; and
b. that is not represented by the manufacturer to be suitable for internal use.
Disorder
A derangement or abnormality of function.
DNA
This is short for “deoxyribonucleic acid”. DNA is in each cell in your body and tells the cells what proteins to make. The proteins control what the cell will do.
DNA (Deoxyribonucleic Acid)
This is the material in the body that holds information about you like hair color and eye color. It is found in each cell. Parents pass on their DNA to their children.
Dosage form
The pharmaceutical form in which a product is presented for therapeutic administration, e.g. tablet, cream.
Dosage regimen
The number of doses per given time period, the time that elapses between doses or the quantity of a medicine that is given at each specific time of dosing.
Drug-Drug interaction
This means there is a change in the way a drug works when it is taken at the same time as another drug.
Drug product
Means the finished dosage form of a medicine prior to the packaging and release for supply steps in the manufacturing process.
Drug resistance
This is when certain bacteria, viruses, and parasites don’t die when treated with some drugs. Once they develop resistance, they can survive and grow, or other drugs have to be used to kill them.
Drug substance
Being replaced by 'active substance'; synonym for 'active pharmaceutical ingredient'.
E
Efficacy
A relative concept referring to the ability of a medicine or treatment to achieve a beneficial clinical effect. This may be measured or evaluated using objective or subjective parameters.
EKG or ECG
This means electrocardiogram. This test measures the electrical activity in your heart. This test does not hurt.
ELISA
Enzyme-linked immunosorbent assay
EP, EPI
This is part of a word. It means over or above.
Epidermis
This means the top layer of skin.
Excluded goods
Goods which might be considered to be therapeutic goods but which are specifically declared not to be by an Order of the Secretary (and therefore not subject to any requirements of the Act).
Exempt goods
Therapeutic goods that are exempted from the requirements to be Registered or Listed, or are exempted from licensing requirements by the Therapeutic Goods Regulations.
Expiry date
The date (month and year) after which the goods should not be used.
*Export certificate (devices) *
A certificate issued for therapeutic devices equivalent to the WHO Certificate of a Pharmaceutical Product.
Export certification
See Section 58 of the Therapeutic Goods Act. Can include a WHO Certificate of a Pharmaceutical Product for medicines, a Certificate of Free Sale (Devices) or an Export Certificate (Devices).
Export name
The proprietary name used for the goods for supply in another country where that name is different from the proprietary name used for the goods for supply in Australia.
Export only medicine
Medicine that:
a. is manufactured in Australia for export only, or imported into Australia for export only; and
b. is listable goods only because it is so manufactured or imported (and not for any other reason)
F
Failure mode
In relation to the recall of therapeutic goods, means how the failure will be presented.
Failure rate
In relation to the recall of therapeutic goods, means the frequency with which the failure occurs for the affected stock.
FFS
Form Fill Seal
Fill volume
Agreed specification of the target volume of a drug product in the final container.
Finished dosage form
Synonym for drug product: the medicine before the packaging manufacturing steps.
Finished goods
Synonym for finished product
Finished product
Medicinal product when all stages of manufacture except for release for supply have been completed.
Formulation
A list of the ingredients used in the manufacture of a dosage form and a statement of the quantity of each ingredient in a defined weight, volume, unit or batch.
G
Gazetted therapeutic goods group
A group of medicines which have common characteristics, that are identified in an order published in the Commonwealth Government Notices Gazette.
GC
Gas Chromatography
Generic medicine
The Therapeutic Goods Regulations 1990, Regulation 2, defines a generic medicine as 'a medicine that, in comparison with a registered medicine:
a. has the same quantitative composition of therapeutically active substances, being substances of similar quality to
those used in the registered medicine or previously registered medicine; and
b. has the same pharmaceutical form; and
c. is bioequivalent; and
d. has the same safety and efficacy properties
GHTF
Global Harmonization Task Force
Global Medical Device Nomenclature (GMDN)
A collection of internationally recognised terms used to accurately describe and catalogue medical devices, in particular, those products used in the diagnosis, prevention, monitoring, treatment or alleviation of disease or injury in humans.
GLP
Good Laboratory Practice
GM
Genetically Modified
GMP clearance
The approval of GMP documentary evidence that shows a manufacturer is of an acceptable standard.
Good clinical practice
A standard for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity and confidentiality of trial subjects are protected.
Good manufacturing practice (GMP)
The acronym GMP is used internationally to describe a set of principles and procedures which, when followed by manufacturers of therapeutic goods, helps ensure that the products manufactured will have the required quality. A basic tenet of GMP is that quality cannot be tested into a batch of product but must be built into each batch of product during all stages of the manufacturing process. (Also see: Good manufacturing practice for therapeutic goods).
Grouped therapeutic goods
Medicines, devices or kits grouped under the one ARTG number (not to be confused with gazetted therapeutic goods group which only refers to medicines).
GTRAP
Gene and Related Therapies Research Advisory Panel
H
Hazard alert
a type of recall action that is issued for an implanted therapeutic good with a deficiency or potential deficiency relating to its safety, quality, performance or efficacy because implanted goods (medical devices or biologicals) cannot be recalled.
HBsAg
Hepatitis B surface antigen
HBV
Hepatitis B virus
HCN
Herbal component name
HCT
Human cellular and tissue therapies
HCV
Hepatitis C virus
HEM, HEMA, HEMO
This is part of a word. It means blood. Hematoma means a swelling with blood inside.
HIV
Human Immunodeficiency Virus
Homologous use
Is use of human cells or tissues to repair, reconstruct, replace or supplement the cells or tissues of a person (the recipient), if the goods will perform the same basic function or functions in the recipient as the original cells or tissues performed in the person from whom they were collected (donor).
HPC-A
Haematopoietic progenitor cells-apheresis
HPC-C
Haematopoietic progenitor cells-cord
HPC-M
Haematopoietic progenitor cells-marrow
HPCs
Haematopoietic progenitor cells: cells that are primitive multipotent cells capable of self-renewal as well as differentiation and maturation into all haematopoietic lineages.
HPLC
High Performance Liquid Chromatography
HREC
Human research ethics committee. More information: National Health and Medical Research Council
HRT
Hormone replacement therapy
h.s.
hora somni, at bedtime
HTLV-1
Human T-lymphotropic viruses type 1
Human embryo
A live embryo that has a human genome or an altered human genome and that has been developing for less than 8 weeks since the appearance of 2 pro-nuclei or the initiation of its development by other means.
Human embryonic stem cell
Undifferentiated cells, derived from a human embryo, that have the potential to become a wide variety of specialised cell types.
HVAC
Heating Ventilation and Air Conditioning - air handling systems used in production facilities including appropriate filters.
Hyper
This is part of a word. It means more or over. For example, a hyperactive thyroid puts too many thyroid hormones in the blood.
Hypo
This is part of a word. It means less. For example, a hypoactive thyroid is not making enough thyroid hormones in your body.
I
ICH
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use
ICH E3
ICH Harmonised Tripartate Guidance Structure and Content of Clinical Study Reports
ICRP
International Commission on Radiological Protection
i.d.
idem, the same
Implantable medical device
A medical device (other than an active implantable medical device) that is intended by the manufacturer:
a. to be, by surgical intervention, wholly introduced into the body of a human being, and to remain in place after the procedure; or
b. to replace, by surgical intervention, an epithelial surface, or the surface of an eye, of a human being, and to remain in place after the procedure; or
c. to be, by surgical intervention, partially introduced into the body of a human being, and to remain in place for at least 30 days after the procedure
Indications
Means the specific therapeutic uses of the goods
INS
International Numbering System (for food additives)
Intended purpose
Of a kind of medical device, means the purpose for which the manufacturer of the device intends it to be used, as stated in:
a. the information provided with the device; or
b. the instructions for use of the device; or
c. any advertising material applying to the device
Intermediate product
Partly processed material from a manufacturer with a current TGA licence or GMP clearance that must undergo further manufacturing steps before it becomes a bulk product.
Invasive medical device
A medical device that is intended by the manufacturer to be used, in whole or in part, to penetrate the body of a human being through a body orifice or through the surface of the body.
IPD
Individual patient data
IR
Infra Red
IRIS
Incident Report Investigation Scheme
ISO
International standard
IVD or IVDD
In vitro diagnostic device
J
JETACAR
Joint Expert Technical Advisory Committee on Antibiotic Resistance
K
Kit listed as either medicine or device kits. A package and therapeutic goods in the package together constitute a kit for the purposes of the Therapeutic Goods Act 1989 if: a. the package and the therapeutic goods are for use as a unit; and b. each item of the therapeutic goods consists of goods that are registered or listed or are exempt goods in relation to Part 3-2; and c. the package and therapeutic goods do not constitute a composite pack or a system or procedure pack.
L
Label
Means a display of printed information:
a. on or attached to the goods; or
b. on or attached to a container or primary pack in which the goods are supplied; or
c. supplied with such a container or pack
LAL
Limulus amoebocyte lysate
Life-threatening condition
A condition where the prominent feature (i.e. affecting an important portion of the target population) is serious illness from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of treatment based on mortality and life expectancy data.
Listable goods
Therapeutic goods that are required by the Act to be included in that part of the ARTG relating to Listed goods
Listed goods
Therapeutic goods that are included in the part of the ARTG for goods known as Listed goods
Listing number
In relation to listed goods, means any combination of numbers, symbols and letters assigned to the goods under section 27 of the Act.
M
Manufacture
The production of medicines or any part of the process of producing medicines or bringing the goods to their final state, including engaging in the processing, assembling, packaging, labelling, storage, sterilising, testing or releasing for supply of the goods or of any component or ingredient of the goods as part of that process.
Manufacturer
Corporation or person carrying out one or more of the steps specified in the definition of manufacture.
Manufacturing certificates
A certificate issued by a regulatory authority to a specific manufacturing site, outlining the manufacturing operations for which the site is authorised and stating the GMP compliance status of the site at a particular point in time.
Examples of manufacturing certificates:
• Certificate of Good Manufacturing Practice (GMP)
• Certificate of GMP Compliance of a Manufacturer
• GMP Certificate
Manufacturing licence
A licence granted under Part 3-3 of the Therapeutic Goods Act 1989 relating to manufacturing therapeutic goods.
Marketing authorisation
The approval given to supply a therapeutic good in Australia, involving entry on the ARTG.
The marketing authorisation includes the details of the product in the ARTG, as well as all other matters in relation to product registration, listing or inclusion agreed in writing between TGA and the sponsor, and any other requirements imposed by a relevant Delegate of the Secretary upon ARTG entry.
MCB
Master Cell Bank
MDEC
Medical Devices Evaluation Committee
MEC
Medicines Evaluation Committee
Medical practitioner
A person who is registered, in a State or internal Territory, as a medical practitioner.
Medicinal component
The name applied by the ARTG to any one item within a composite pack.
Medicinal product
A product that is a medicine
MMF
Manufacturer's Master File
MoI
Memorandum of Intention
Mother tincture
A product of the process of solution, extraction or trituration, from which homoeopathic preparations are made.
MoU
Memorandum of Understanding
MRA
Mutual Recognition Agreement
MS
Mass Spectrometry
Multidose use
Intended for use on more than one occasion.
N
Name of the goods
The non-proprietary name including the name of the dosage form or a synonym for the name of the dosage form, used to describe the goods in a specific standard. Listing and registration names include the name of the goods but may include further information to differentiate between forms of presentation.
Naso
This is part of a word. It means nose. Nasogastric tube means a tube that goes down your nose. The tube goes into your stomach.
Natural origin
In the context of the microbial quality of prescription and over-the-counter medicines means: a medicine that contains a raw material(s) of natural origin (animal, vegetal or mineral) where the raw material has not been fully processed.
NBE
New Biological Entity
NCCTG
National Coordinating Committee on Therapeutic Goods
NDPSC
National Drugs and Poisons Schedule Committee
NeeS
Non-eCTD Electronic Submission - an alternative electronic standard to eCTD consisting of PDF Files and PDF Table of Contents linking all content for navigational purposes.
NHMRC
National Health and Medical Research Council
NICNAS
National Industrial Chemicals Notification and Assessment Scheme
Node extensions
In relation to eCTD, additional heading structures beyond those defined by the specifications - generally equated to an additional subfolder in a defined section.
Non-critical device
A device that only comes in contact with intact skin or does not come in contact with the human body.
Non-proprietary name
The name used to describe the goods (particularly medicines) in a specific standard, including the name of the dosage form (if no standard exists, a name may comprise the AAN of the active ingredient and the name of the dosage form).
Non-recall action
A type of action taken if therapeutic goods meet all specifications and standards and there are no deficiencies in safety, quality, efficacy, performance or presentation.
Nonclinical
The preclinical, pharmaco-toxicological and pharmacological or toxicological studies.
Nonconformity
Non-fulfilment of a requirement (based on ISO 9000 Clause 3.6.9); term is used in medical device manufacturer audits.
Nontransparent monograph
In relation to impurities in drug substances is a monograph that either does not have a test for impurities or, if it does have such a test, does not list those impurities.
O
OOS
Out-of-Specification - Test results that fall outside the specifications or acceptance criteria that have been specified.
OOT
Out-of-Trend - Test results that are within specification or acceptance criteria, but fall outside the range of values expected, when viewed alongside historical results or results obtained for comparable lots of material.
Open shelf life
The shelf life of a therapeutic good once the immediate container, in which the therapeutic good has been supplied, has been opened.
Open-but-unused
Refers to a single use device where the packaging has been damaged or opened but the device not used and/or did not come in contact with blood, tissue or body fluids.
Operational qualification
The documented verification that the facilities, systems and equipment, as installed and modified, perform as intended throughout the intended operating ranges.
OTGs
Other therapeutic goods
Overage
Increased content of drug substance, usually due to loss of potency on storage.
Overfill
Increased volume of drug product to account for loss during delivery.
P
Pack size
The size of the goods in terms of the quantity contained in the container (e.g. volume in a multi-use container) and/or the number of items in the primary/unit pack (e.g. number of tablets in a bottle).
Packaging material
Any material employed in the packaging of a medicinal product, excluding any outer packaging used for transportation or shipment. Packaging materials are referred to as primary or secondary according to whether or not they are intended to be in direct contact with the product.
Packaging, secondary
Any packaging or labelling process (including repackaging and labelling, over-labelling and supplementary labelling) where the medicine is already in the primary container, and that primary container is not opened, breached or modified in the secondary packaging process.
PAR
Provisional ARTG record
Partially processed goods
Therapeutic goods whose manufacture has not been completed to the stage of final packaging and labelling.
Patient harm
Physical or psychological injury or damage to the health of patients, including death.
Performance qualification
The documented verification that the facilities, systems and equipment, as connected together, can perform effectively and reproducibly, based on the approved process method and product specification.
PET
Positron emission tomography
Physical assessment
In relation to blood, blood components or biologicals: means a clinical inspection of a living or deceased potential donor to determine suitability of the person to be a donor and may include, but is not limited to, assessing the relevance of any abrasion/laceration, bruise/haematoma, fracture, tattoo, piercing, scar, skin lesion, surgical incision or other distinguishing external feature that may be indicative of a behaviour or lifestyle or suggestive of any risk factor in relation to a relevant communicable disease.
Placebo
An inactive substance or treatment that supposedly has no treatment value. It is given to participants in clinical trials as a control against which to compare the effects of the test substance. In practice, placebos may also have positive or negative effects on trial participants.
Plasma
The liquid part of uncoagulated blood or lymph, as distinguished from the corpuscles
PMF
Can mean Plasma Master File or Plant Master File depending on the context
Poisons Standard
The legal title of the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP), it is a Legislative Instrument consisting of decisions regarding the classification of medicines and poisons into Schedules. Scheduling is a national classification system that controls how medicines and poisons are made available to the public. Medicines and poisons are classified into Schedules according to the level of regulatory control over the availability of the medicine or poison, required to protect public health and safety.
Potentially hazardous
In relation to a medical device, means that the basic risk of the device, before deliberate measures have been taken to minimise risk by inherent design or protection mechanisms, is considered intolerable
PPF
Pre-submission planning form
PQR
Product Quality Review - a periodic or rolling quality review of all licensed medicinal products.
PQS
Pharmaceutical Quality System - updated terminology for QMS, used in the PIC/S Guide to GMP.
Preliminary Clinical Data
In relation to medicines, means data based on controlled studies conducted according to internationally recognised standards establishing that the medicine has an effect on a surrogate, clinical or other early endpoint that is reasonably likely to predict clinical benefit.
Prescribed quality and safety criteria
See Section 26(1)(k) of the Therapeutic Goods Act 1989. Quality and safety requirements prescribed in the Regulations for particular listable goods or categories of listable goods.
Prescription medicine
(other than where it is a substitute medicine) means a registered therapeutic good included in the ARTG that:
• is a medicine within the meaning of the Act;
• contains a substance mentioned in Schedule 4 or 8 to the Poisons Standard; and
• is normally available for supply in Australia.
Prescription medicines require an authorised health professional's written instruction (prescription) before they can be obtained from a registered pharmacist. The types of therapeutic goods that are regulated as prescription medicines are listed in Part 1 of Schedule 10 of the Therapeutic Goods Regulations 1990.
Principal manufacturer
The manufacturer who manufactures the goods or who performs one or more steps in the manufacture of the goods and also contracts with, or controls the use of other sub-manufacturers for the performance of the remaining steps in manufacture of the goods
Product Information (PI)
Product information is defined in s3 of the Therapeutic Goods Act 1989 to mean:
'in relation to therapeutic goods, information relating to the safe and effective use of the goods, including information regarding the usefulness and limitations of the goods'.
Proprietary name
As defined in Therapeutic Goods Order No. 69 General requirements for labels for medicines (2001) means the registered trademark of the therapeutic goods or the unique name assigned to the goods by the sponsor and appearing on a label.
PSC
Pharmaceutical Subcommittee (of ACPM)
Q
QA
Quality assurance
QMS
Quality Management System - a set of policies, processes and procedures required for planning and execution (production/development/service) in the core business area of an organisation.
QRM
Quality Risk Management - A systematic process for the assessment, control, communication and review of risk to the quality of medicinal products.
QSAR
Quantitative structure activity relationships
Qualification
In relation to impurities in drug substances, the process of acquiring and evaluating data that establish the biological safety of an individual impurity or a given impurity profile at the level(s) specified.
Qualification threshold
In relation to impurities in drug substances, a limit above which a degradation product should be qualified.
Quality
In relation to therapeutic goods, includes the composition, strength, potency, stability, sterility, purity, bioburden, design, construction, and performance characteristics of the goods.
Quarantine
This is when a person with germs is kept away from others. The germs can make other people sick. Quarantine keeps other people safe.
R
Regulations
The Therapeutic Goods Regulations 1990.
Reusable device
A device designed or intended by the manufacturer as suitable for reprocessing and reuse. It is not a device that is designed or intended by the manufacturer for single use only.
Reuse
The repeated use or multiple use of any medical device which has undergone some form of reprocessing (cleaning, disinfection or sterilisation) between each episode of use.
RFFP
Release for further processing - a release step in the manufacture of medicinal products prior to the final release for supply step.
RFS
Release for Supply - release of finished product for supply.
RMP
Risk management plan
Route of administration
Route by which a therapeutic good is applied on or introduced into the body.
S
Safety alert
A type of non-recall action issued by sponsors that consists of advice on the safe use of therapeutic goods in certain situations where, although meeting all specifications and therapeutic indications, its use could present an unreasonable risk of harm if certain specified precautions in regard to its use are not followed.
SAL
Sterility assurance level
SAN
Self-assessable notification
SAR
Self-assessable request
SAS
Special Access Scheme
Secretary
Means the Secretary of the Department of Health
Self-manageable
Indicates whether the diagnosed condition is beyond the ability of the average consumer to evaluate accurately and manage safely without the supervision by and assistance from a suitably qualified health care professional.
Self-preserving
A formulation that does not require addition of a preservative(s) to meet the preservative efficacy criteria.
Semi-critical device
A device is one that comes into contact with intact mucous membranes or broken skin. The device should be sterilised where possible, or high-level disinfected.
Semisynthetic drug substance
A substance in which the structural constituents have been introduced by a combination of chemical synthesis and elements of biological origin (e.g. obtained from fermentation or by extraction from botanical material).
Seriously debilitating condition
A condition that has as a prominent feature (i.e. affecting an important portion of the target population) which is morbidity with a well-established, major impact on the functioning of the person based on objective and quantifiable medical or epidemiologic information. Short-lived and/or self-limiting morbidity is not considered seriously debilitating.
Service goods
Therapeutic goods which are required in the public interest but whose supply does not offer financial incentive for the sponsor.
Shelf life
The time period during which a therapeutic good is expected to remain within the approved shelf life specification, provided that it is stored under the conditions defined on the container label.
Shortage
In relation to a medicine, means that the supply of the medicine is not reasonably likely to meet the normal or projected consumer demand for the medicine within Australia for a period of time.
Sign
Any objective evidence of a disease, that is, such evidence as is perceptible to the examining physician, as opposed to the subjective sensations (symptoms) of the patient.
Single patient use
More than one episode of use of a medical device on one patient only, the device may undergo some form of reprocessing between each use in accordance with the manufacturer’s instructions for reuse on the same patient.
Single step of manufacture
For the purpose of annual licence charge classification only - for example one of the following: tablet coating; capsule filling from bulk; aerosol filling from bulk; storage other than for sale; packaging including labelling; sterilisation; testing including analysis; assembling devices from components, testing or batch testing of therapeutic devices; releasing for sale (by a person not involved with actually preparing the goods).
Single use
Means the medical device is intended to be used on an individual patient during a single procedure and then discarded. It is not intended to be reprocessed and used on another patient. Some single-use devices are marketed as non-sterile which require processing to make them sterile and ready for use. The manufacturer of the device will include appropriate processing instructions to make it ready for use.
Site
This refers to the place where a clinical trial is conducted. When a clinical trial is conducted at more than one site, but using the same protocol, it is referred to as a multi-site or multi-centre trial.
Site identification
Identification code assigned by the Manufacturer Assessment Section (MAS) to a manufacturing site(s) for an enterprise which is involved with the manufacture of therapeutic goods.
Skin
The outer integument, or covering, of the body — consisting of the dermis and the epidermis and resting upon the subcutaneous tissues.
SME
Small and Medium Enterprises
SPC Summary of product characteristics
Starting material
In relation to a medicinal product, any substance (active or excipient) used in the production of a medicinal product, excluding packaging materials.
Strength
The quantity of an active pharmaceutical ingredient in a medicine or a formulated or medicated device.
Summary of product characteristics (SmPC)
European equivalent to the Australian product information (PI).
Supplier
In general: a person or organisation that is involved in the supply and distribution of the product, but not involved in product manufacture.
In relation to the manufacture of a medicinal product: any entity supplying the starting and/or packaging material to the manufacturer of a medicinal product. This entity should normally be the actual manufacturer of the starting or packaging material, rather than a broker or agent.
Supplier, qualified
An approved supplier, supplying the starting and/or packaging material to the manufacturer of medicinal products, who has undergone the process of supplier qualification. The supplier should normally be the actual manufacturer of the starting or packaging material, not a broker or agent.
Supply
Includes supply:
a. by way of sale, exchange, gift, lease, loan, hire or hire purchase; and
b. whether free of charge or otherwise, by way of sample or advertisement; and
c. whether free of charge or otherwise, in the course of testing the safety or efficacy of therapeutic goods in persons; and
d. by way of administration to, or application in the treatment of, a person.
In relation to a medicine, means the overall arrangements for the meeting of consumer demand.
Symptom
Any subjective evidence of disease or of a patient's condition, that is, such evidence as perceived by the patient.
Syndrome
A set of symptoms which occur together; a symptom complex.
T
t, T or T°
Temperature
Tachy
This is part of a word. It means fast. Tachycardia means fast heartbeat.
Tamper
Therapeutic goods are tampered with if:
a. they are interfered with in a way that affects, or could affect, the quality, safety or efficacy of the goods; and
b. the interference has the potential to cause, or is done for the purpose of causing, injury or harm to any person.
TEP
Tamper-evident packaging
TGA
Therapeutic Goods Administration, which is part of the Department of Health.
TGA Approved Terminology for Medicines
A compendium document which (in the main) identifies terms to be used when making an application to the TGA for registration of medicines.
TGACC
Therapeutic Goods Advertising Code Council
TGC
Therapeutic Goods Committee
TGO
Therapeutic goods order
Therapeutic Goods Order (TGO)
An Australian standard that relates to a particular type of therapeutic good, or specifies particular requirements for labelling, packaging or other aspects.
Tissue
Any constituent part of the body formed by cells
Topical
Applied to a certain area of the skin for a localised effect
Traditional use
Use of a designated active ingredient that is well-documented, or otherwise established, according to the accumulated experience of many traditional healthcare practitioners over an extended period; and accords with well-established procedures of preparation, application and dosage
Transdermal
Applied to the skin for a systemic effect by the diffusion or continuous absorption of the active ingredient through the skin
Transparent monograph
Lists the impurities controlled by that monograph by name and/or chemical structure.
TTC
Threshold of toxicological concern
TWG
Technical Working Groups [manufacturing]
U
URPTG
Uniform Recall Procedure for Therapeutic Goods
USB
Universal serial bus
Used
For medical devices that are supplied sterile:
• the device has been placed into a wound or body cavity and comes into contact with blood or body fluids; or
• has been opened but cannot be reprocessed because the manufacturer did not provide instructions on how to
reprocess the device if the package is opened or damaged.
For medical devices that are supplied non-sterile:
• the device has been applied for its intended purpose.
V
Vaccine
These are drugs that are given to protect from disease. They can be given by mouth or in a shot. A flu shot is a vaccine.
Valve
There are valves in the heart, veins, and other places that keep your blood moving in your body.
Variation
A change to an Australian Register of Therapeutic Goods entry.
Virological
Pertaining to viruses
Virus
This is a tiny germ that causes diseases. Viruses cannot be cured by drugs. Measles and chicken pox are caused by viruses. So is HIV.
Vital physiological process
Of a patient, means a process that is necessary to sustain life and the indicators of which may include any 1 or more of the following:
a. respiration
b. heart rate
c. cerebral function
d. blood gases
e. blood pressure
f. body temperature
VMP
Validation Master Plan - a document which clearly defines the key elements of a validation program to achieve and maintain a qualified facility and associated systems.
W
W3C
World Wide Web Consortium - international standards organisation for the world wide web.
Warning or precaution
One or more statements in the product information (PI) that draw attention to potential adverse effects resulting from product use.
Washout period
The stage in a cross-over trial where treatment is withdrawn before a second treatment is given. This is usually necessary to counteract the possibility that the first substance can continue to affect the subject for some time after it is withdrawn.
WCB
Working Cell Bank
WHO
World Health Organization
X
Xenotransplantation
Refers to any procedure involving the delivery into a human patient of:
live animal cells, tissues or organs
OR
human body fluids, cells, tissues or organs that have had contact with live animal cells or tissues outside the patient's body
X-RAY
This is a high-energy form of radiation used to take a very precise picture of a part of the body.
XER, XERO
This is part of a word. It means dry. Xeroderma is dry skin.