1.

TGA basics
The Therapeutic Goods Administration (TGA) is a division of the Australian Government Department of Health and Ageing, and is responsible for regulating therapeutic goods including medicines, medical devices, blood and blood products. This includes goods that we rely on every day, such as sunscreens, through to goods used to treat serious conditions, for example prescription medicines, vaccines, blood products and implants. Essentially, any product for which therapeutic claims are made must be listed, registered or included in the Australian Register of Therapeutic Goods (ARTG) before it can be supplied in Australia. The TGA evaluates therapeutic goods before they are marketed and monitors products once they are on the market, it also assesses the suitability of medicines and medical devices for export from Australia. The TGA also regulates manufacturers of therapeutic goods to ensure they meet acceptable standards of manufacturing quality. It has a team of manufacturing inspectors that audit manufacturing facilities around the world to ensure that products supplied in Australia are of high quality. The TGA administers the Therapeutic Goods Act 1989. This legislation provides a framework for a risk management approach that allows the Australian community to have timely access to therapeutic goods which are consistently safe, effective and of high quality. The TGA works with consumers, health professionals, industry and its international counterparts in order to effectively regulate increasingly complex products resulting from rapid scientific developments.

2. Who we are & what we do

The Therapeutic Goods Administration is a division of the Australian Government Department of Health and Ageing. The TGA's overall purpose is to protect public health and safety by regulating therapeutic goods that are supplied either imported or manufactured, or exported from Australia. Therapeutic goods include medicines, medical devices and human blood, blood products and tissues. At the same time the TGA aims to ensure that the Australian community has access, within a reasonable timeframe, to new therapeutic goods.

3. What the TGA regulates

The TGA is responsible for ensuring that therapeutic goods available for supply in Australia are safe and fit for their intended purpose. These include goods Australians rely on every day, such as vitamin pills and bandaids, through to goods used to treat serious conditions, such as prescription medicines, vaccines, blood products and surgical implants. The TGA regulates the supply of:

medicines prescribed by a doctor or dentist medicines available from behind the pharmacy counter medicines available in the general pharmacy medicines available from supermarkets complementary medicines, these include vitamins, herbal and traditional medicines medical devices, from simple devices like bandages to complex technologies like heart pacemakers products used to test for various diseases or conditions (in vitro diagnostic devices), such as blood tests; and vaccines, blood products, and other biologics.

and the manufacturing and advertising of these products.

Regulating medicines
The regulation of medicines includes the following features:

classifying the medicine based on different levels of risk to the person taking them implementing appropriate regulatory controls for the manufacturing processes of medicines Medicines assessed as having a higher level of risk (prescription medicines, some nonprescription medicines) are evaluated for quality, safety and efficacy Medicines having a lower risk (medicines purchased over the counter, such as complementary medicines) are assessed for quality and safety Medicines determined to be available for lawful supply by the Therapeutic Goods Administration can be identified by either an AUST R number or an AUST L number on the outer packaging. Please note, there are a small number of medicines that are exempt and do not require this information on the label Once available for supply, medicines are subject to monitoring by the TGA. This monitoring includes a comprehensive adverse event reporting programme.

Regulating medical devices

The regulation of medical devices includes:

classifying the medical device based on different levels of risk to the user assessing compliance with a set of internationally agreed essential principles for their quality, safety and performance implementing appropriate regulatory controls for the manufacturing processes of medical devices

including the medical device in the Australian Register of Therapeutic Goods Once available for supply, medical devices are subject to monitoring by the TGA. This monitoring includes a comprehensive adverse event reporting programme.

Other therapeutic goods regulated by the TGA

The TGA also applies a risk management approach to the regulation of:

In vitro diagnostic medical devices (IVDs) blood blood components plasma derivatives tissue and cellular products tissue and cell based derivatives sterilants and disinfectants

4. TGA structure
16 May 2011 The Therapeutic Goods Administration (TGA) is a division of the Australian Government Department of Health and Ageing. The TGA's offices are grouped into three core groups Market Authorisation Group, Monitoring and Compliance Group and Regulatory Support Group.

A.TGA Executive
The TGA Executive has overall responsibility for the management of the TGA's regulatory functions and activities. The TGA Executive comprises:

TGA National Manager, Dr Rohan Hammett Principal Medical Adviser, Dr Megan Keaney Principal Legal Adviser, Ms Philippa Horner Chief Regulatory Officer, Ms Jenny Hefford Principal Adviser (Operations), Mr Stephen Dellar

B. Market Authorisation Group

The Market Authorisation Group (MAG) is responsible for undertaking evaluations of applications to approve new therapeutic products for supply in Australia. The MAG makes decisions whether to approve or reject market authorisation of medicines, medical devices and blood and tissues that are imported, exported, manufactured and supplied in Australia. The MAG's Group Coordinator is Ms Judy Develin.

The Offices and Units in the MAG are:

Office of Medicines Authorisation (OMA)

Office Head: Dr Harry Rothenfluh

The OMA is responsible for approving prescription and non-prescription medicines.

Office of Complementary Medicines (OCM)

Office Head: Mr Ian Stehlik

The OCM is responsible for approving complementary medicines, including traditional and herbal medicines and vitamin and mineral supplements.

Office of Devices Authorisation (ODA)

Office Head: Ms Andrea Kunca

The ODA is responsible for approving medical devices.

Office of Scientific Evaluation (OSE)

Office Head: Dr Mark McDonald

The OSE provides scientific advice to support the decisions made by the Market Authorisation Group. This includes clinical, toxicological, biological sciences and pharmaceutical chemistry evaluation of therapeutic products. It also includes the Experimental Products Unit which is responsible for the evaluation and authorisation of certain clinical trials and special access arrangements for all types of therapeutic products.

Group Support Unit (GSU)

The GSU is responsible for providing planning, coordination and administrative services to all areas of the Group.

C. Monitoring and Compliance Group

The Monitoring and Compliance Group (MCG) is responsible for ongoing monitoring of therapeutic products approved for supply in Australia to ensure they meet the necessary standards throughout their lifecycle. The way our medicines and devices are manufactured is also regulated by the TGA. Australian and international manufacturers must operate in a manner that results in products meeting specified standards if they are to be supplied in Australia. The TGA conducts regular inspections

of manufacturers, both in Australia and overseas, to ensure they continue to meet these standards. The MCG's Group Coordinator is Dr Larry Kelly. The Offices and Units in the MCG are:
Office of Product Review (OPR)

Office Head: Dr Jane Cook

The OPR is responsible for overseeing all therapeutic products to ensure they continue to maintain an appropriate level of quality, safety, efficacy and performance following entry into the Australian marketplace. This includes monitoring reports of adverse events and reviewing medicine ingredients and device components. The Advertising and Recalls Unit also sits within OPR and is responsible for administering legislative requests for the advertising of therapeutic goods in Australia and coordinating product recalls when necessary.

Office of Laboratories and Scientific Services (OLSS)

Office Head: Dr Peter Bird

The OLSS is responsible for conducting laboratory testing, quality assessment and test procedure development in scientific disciplines such as, microbiology, immunobiology, molecular biology, biochemistry, chemistry, and biomaterials and engineering.

Office of Manufacturing Quality (OMQ)

Office Head: Mr Bill Turner

The OMQ is responsible for ensuring manufacturers of medicines and medical devices meet appropriate standards of quality.

Group Support Unit (GSU)

The GSU is responsible for providing planning, coordination and administrative services to all areas of the MCG.

D. Regulatory Support Group

The Regulatory Support Group provides whole-of-agency regulatory support services that enable the TGA to undertake its regulatory responsibilities. This includes the legal, finance, information technology and information management, communications, parliamentary and human resource management services.

The Offices and Units in the Regulatory Support Group are:

Office of Legal Services (OLS)

Office Head: Ms Terry Lee

The OLS provides a full range of legal services for the TGA.

Office of Information Management (OIM)

Office Head: Mr Peter Bickerton

The OIM manages the delivery of Information Technology and Information Management, records management and the TGA library.

Office of Parliamentary and Strategic Support (OPSS)

Office Head: Mr Pio Cesarin

The OPSS provides a strategic, coordinated and whole of agency approach to the management of the TGA's communications, parliamentary services and committee support, stakeholder and international engagement, cross-agency projects, reforms to the TGA's regulatory operations, and human resources.

Regulatory Compliance Unit

The Unit is responsible for on-going surveillance, enforcement and related activities, including investigations into illegal and counterfeit therapeutic goods.

Chief Financial Officer

Chief Financial Officer: Mr Vinod Mahajan

The Chief Financial Officer provides oversight of the TGAs finance and property services.

Office of Regulatory Integrity

The Office of Regulatory Integrity (ORI) provides an independent and objective review and advisory service to provide assurance to the National Manager of the TGA that the TGA's financial and operational controls are operating in an efficient, effective and appropriate manner and that its regulatory controls are operating in an efficient, effective and appropriate manner and are consistent with relevant legislative requirements. ORI activities encompass review activities, especially in relation to compliance and performance improvements, compliance activities, advisory services for new programs and assistance with risk management and fraud control programs and management of TGA's insurance coverage.

The Head of the ORI is Dr Leonie Hunt.

5. TGA legal expenditure

28 October 2010

External legal expenditure 2009-2010

Paragraph 11.1(da) of the Legal Services Directions 2005 requires agencies regulated by the Financial Management and Accountability Act 1997 (FMA agencies) to report to the Office of Legal Services Coordination (OLSC) on their legal services expenditure. Paragraph 11.1(ba) of the Legal Services Directions 2005 requires that, by 30 October each year, agencies make publicly available records of the Legal Services Expenditure for the previous year.

The Therapeutic Goods Administration total external legal expenditure (GST inclusive) for 2009-2010 was as follows:
External expenditure External expenditure External expenditure on other Total external on solicitors on barristers disbursements expenditure $878,055 $143,051 $141,186 $1,162,293

Note: Registration costs associated with the Federal Register of Legislative Instruments and costs for preparing legislative instrument compilations have not been included.

Internal legal expenditure 2009-2010

The Therapeutic Goods Administration total internal legal expenditure (GST inclusive) 20092010 was: $3,016,198.57. This represents the cost of maintaining an in-house legal branch (this includes administrative staff), which provides all in-house legal services, including advisings, legislation, legal training, briefing on litigation, commercial law, etc.

6. Freedom of information
Related information

Information Publication Scheme Documents released under Section 11C of the FOI Act 1982

The Freedom of Information Act 1982 (FOI Act) gives you the right to:

access copies of documents (except exempt documents) we hold ask for information we hold about you to be changed or annotated if it is incomplete, out of date, incorrect or misleading, and seek a review of our decision not to allow you access to a document or not to amend your personal record.

You can ask to see any document that we hold. We can refuse access to some documents, or parts of documents that are exempt. Exempt documents may include those relating to national security, documents containing material obtained in confidence, material that is commercial-inconfidence, Cabinet documents, or other matters set out in the FOI Act. Unless information is personal or commercial and publication would be "unreasonable", any information provided in response to an FOI request will be listed in the Department of Health and Ageing's FOI disclosure log. It may also be published on a website, or if it not practical to do so, provided on request.

Documents available outside the FOI Act

How to make a request Fees and charges What you can expect from us If you disagree with our decision Internal review Complaints More information

Documents available outside the FOI Act

You should check the information we have published under the Information Publication Scheme and FOI Disclosure Log to see if the information you are seeking is already available.

How to make a request

Your request must:

be in writing state that the request is an application for the purposes of the FOI Act provide sufficient information about the document(s) to allow us to process your request, and provide an address for reply.

You can send your request:

The FOI Coordinator Legal Services Branch By post Department of Health and Ageing GPO Box 9848 CANBERRA ACT 2601 or By email foi@health.gov.au

If you ask a third party to make an FOI request on your behalf, you need to provide a specific, written authority to send copies of documents to you, care of that person, or to allow that person to inspect copies of documents containing information about you. If you require more information, please contact the FOI Contact Officer by emailing foi@health.gov.au or calling the Department of Health and Ageing on 1800 020 103 or 02 6289 1555.

Fees and charges

There is no application fee for an FOI request.

There are no processing charges for requests for access to documents containing only personal information about you. However, processing charges may apply to other requests. The most common charges are:
Activity item Search and retrieval: time we spend searching for or retrieving a document Charge $15.00 per hour

Decision making: time we spend in deciding to grant or refuse a request, First five hours: Nil including examining documents, consulting with other parties, and making Subsequent hours: deletions

$20 per hour

Transcript: preparing a transcript from a sound recording, shorthand or similar $4.40 per medium transcript Photocopy page of

$0.10 per page

Inspection: supervision by an agency officer of your inspection of documents or $6.25 per half hour (or hearing or viewing an audio or visual recording at our premises part thereof) Delivery: posting or delivering a copy of a document at your request Cost of postage or delivery

If we decide to impose a charge, we will give you a written estimate and the basis of our calculation. Where the estimated charge is between $20 and $100, we may ask you to pay a deposit of $20, or where the estimated charge exceeds $100, we may ask you to pay a 25% deposit before we process your request. You can ask for the charge to be waived or reduced for any reason, including financial hardship or on the grounds of public interest. If you do so, you should explain your reasons and you may need to provide some evidence.

What you can expect from us

We will tell you within 14 days that we have received your request and give you an estimate of the charges that apply to your request. We will give you our decision within 30 days unless that time has been extended. If a document contains information about a third party and we need to consult them, the time to give you our decision will be extended by another 30 days. We may also seek your agreement to extend the time by up to 30 days if your request is complex. Unless the information is personal or is about the commercial, financial or professional affairs of a person and publication would be "unreasonable", any information provided to you in response to your request will be listed in the Disclosure Log and published or otherwise made available to anyone who requests access.

If you disagree with our decision

When we have made a decision about your FOI request, we will send you a letter explaining our decision and your review and appeal rights. You can ask for the following decisions to be reviewed:

if we refuse to give you access to all or part of a document or if we defer giving you access if we impose a charge if we refuse to change or annotate information about you that you claim is incomplete, incorrect, out of date or misleading.

A third party who disagrees with our decision to give you documents that contain information about them can also ask for our decision about that information to be reviewed.

Internal review
You can request in writing that we reconsider our decision through an internal review. An internal review will be conducted by another officer in our agency. We will advise you of our new decision within 30 days of receiving your request.
Information Commissioner review

You can ask the Australian Information Commissioner to review our original decision or our decision on internal review within 60 days of the date of decision (or 30 days after you are notified if you are an affected third party). The Information Commissioner can affirm or vary the decision or substitute a new decision. The Information Commissioner may decide not to conduct a review in certain circumstances. More information is available at the Office of the Australian Information Commissioner (OAIC) website.

Complaints
If you are unhappy with the way we have handled your request, you can complain to the Australian Information Commissioner who may investigate our actions. More information is available on the OAIC's website. The Commonwealth Ombudsman can also investigate complaints about our actions. However, the Commonwealth Ombudsman and the Information Commissioner will consult to avoid the same matter being investigated twice.

7. TGA business process improvement

Introduction
In early 2009, the TGA commenced a significant program of business process reforms (BPR program) for the regulation of prescription medicines in Australia. The key elements of the BPR program were identified during an industry consultation workshop held on 17 December 2007

which brought together representative of the TGA, Medicines Australia, and the Department of Health and Ageing. These initiatives are part of the Australian Government's broader regulatory reform agenda. There are three projects within the BPR program:

Streamlined submission process project PI/CMI project AusPAR project

Streamlined submission process project

The streamlined submission process project will improve submission quality and provide predictable timeframes for the evaluation and registration of prescription medicines in Australia.
More about the streamlined submission process project

Streamlined submission process for prescription medicines

PI/CMI project
Since November 2009, the PI/CMI project has been providing through the TGA website, a single trusted source for product information (PI) and consumer medicine information (CMI). This will provide consumers and health professionals with enhanced access to prescription medicine information.
More about the PI/CMI project

PI/CMI project

AusPAR project
The AusPAR project is increasing the transparency of the prescription medicine regulatory process by publicly releasing (since December 2009), Australian Public Assessment Records (AusPAR) for new products of major variations to existing products. AusPARs provide information about the TGA's evaluation of a prescription medicine and the considerations that led the TGA to approve or not approve a prescription medicine for registration in Australia.

8. Publications
The Therapeutic Goods Administration (TGA) publishes a range of publications, guidelines and forms as part of its regulatory activities. These are aimed at consumers, health professionals or people working in the medical device or medicines industries.

The links below are categorised by topic. This list is also available in an A-Z list.

Advertising publications Blood, tissues & biologicals publications Complementary medicines publications Import/export publications Labelling & packaging publications Manufacturing publications Medical devices & IVDs publications OTC medicines publications Prescription medicines publications Safety of medicines & medical devices publications Scheduling publications TGA publications

Advertising publications

Price information code of practice Schedule 3 advertising guidelines Therapeutic goods advertising code

Blood, tissues & biologicals publications

Australian code of GMP for human blood and tissues Australian regulatory guidelines for biologicals (ARGB) Enforcement guidelines Guideline for the preparation of Technical Master Files for blood, blood components and haematopoietic progenitor cells TGA biologicals framework newsletter

Complementary medicines publications

Analytical procedure validation for complementary medicines Australian regulatory guidelines for complementary medicines (ARGCM) Colourings permitted in medicines for oral use Electronic listing facility (ELF) user guide Enforcement guidelines Guidance on equivalence of herbal extracts in complementary medicines Guidance on product changes in ELF3 Guidance on the use of modified unprocessed herbal materials in complementary medicines Guidelines for levels and kinds of evidence to support indications and claims Identification of herbal materials and extracts Required advisory statements for medicine labels (RASML) Stability testing of Listed complementary medicines Substances that may be used in Listed medicines in Australia TGA approved terminology for medicines

Import/export publications

Exporting medicines from Australia - operational guidelines Personal import scheme

Labelling & packaging publications

A guide to labelling drugs and poisons Best practice guideline on prescription medicine labelling NDPSC guide to the packaging, labelling and regulation of paints, tinters and related products Required advisory statements for medicine labels (RASML) Tamper-evident packaging code of practice

Manufacturing publications

Australian code of GMP for human blood and tissues Australian code of good wholesaling practice for medicines in schedules 2, 3, 4 & 8 Australian code of good wholesaling practice for therapeutic goods for human use Enforcement guidelines Guide to interpretation of the Code of GMP for the manufacture of 18-Fludeoxyglucose injections Guideline for the preparation of Technical Master Files for blood, blood components and haematopoietic progenitor cells Guidelines for sterility testing of therapeutic goods PIC/S explanatory notes for pharmaceutical manufacturers on the preparation of a site master file PIC/S guide for good manufacturing practice for medicinal products

Medical devices & IVDs publications

Australian regulatory guidelines for medical devices (ARGMD) Device-medicine boundary products Enforcement guidelines Medical device incident reporting & investigation scheme (IRIS) articles Requirements for the assessment of medical devices containing animal material

OTC medicines publications

Australian regulatory guidelines for OTC medicines (ARGOM) Colourings permitted in medicines for oral use Enforcement guidelines Guidelines for levels and kinds of evidence to support indications and claims Required advisory statements for medicine labels (RASML) TGA approved terminology for medicines

Prescription medicines publications

Australian regulatory guidelines for prescription medicines (ARGPM)

Best practice guideline on prescription medicine labelling Colourings permitted in medicines for oral use Enforcement guidelines European Union guidelines Guidance for industry on electronic prescription medicine submission dossiers Guideline on prescription medicine discontinuations Literature-based submissions - points to consider Prescription medicine BPR update newsletter Proposal to amend the Required Advisory Statements for Medicine Labels (RASML) Required advisory statements for medicine labels (RASML) TGA approved terminology for medicines

Safety of medicines & medical devices publications

Australian Adverse Drug Reactions Bulletin Australian clinical trial handbook Australian pharmacovigilance guideline for sponsors Human Research Ethics Committees and the therapeutic goods legislation Joint ADRAC-Medicines Australia guidelines for the design and conduct of company-sponsored post-marketing surveillance (PMS) studies Medical device incident reporting & investigation scheme (IRIS) articles Medicines Safety Update Note for guidance on clinical safety data management: definitions and standards for expedited reporting Note for guidance on good clinical practice Uniform recall procedure for therapeutic goods (URPTG)

Scheduling publications

NCCTG scheduling policy framework The Poisons Standard (the SUSMP)

TGA publications

A history of therapeutic goods regulation in Australia TGA advisory committee guidelines TGA News

9. Regulation basics
The Australian community expects therapeutic goods in the marketplace to be safe, of high quality and of a standard at least equal to that of comparable countries. The TGA is responsible for ensuring that therapeutic goods available for supply in Australia are safe and fit for their intended purpose. These include goods Australians rely on every day, such as vitamin pills and bandaids, through to goods used to treat serious conditions, such as prescription medicines, vaccines, blood products and surgical implants.

A. How therapeutic goods are regulated in Australia

This topic explains in general terms how therapeutic goods are regulated in Australia. More detailed information is available under each of the product areas (see the left navigation).

a. Medicines and TGA classifications

28 April 2011 Within the regulatory framework, medicines are classified into several categories:

Registered medicines o Prescription (high risk) registered o Non-prescription (low risk) registered Listed medicines o Most over the counter medicines Complementary medicines

Assistance in preparing applications

Professional agents are available to assist in the preparation of applications for listing or registering medicines in the Australian Register of Therapeutic Goods. These can be found through ARCS Australia or the relevant industry association. See: Regulatory affairs consultants Please note that the TGA makes no representations as to the suitability or performance of consultants listed by ARCS or the relevant industry association.

b. What are 'therapeutic goods'?

15 August 2011 Many of us use medicines or medical devices in our daily lives. When we:

apply a bandage relieve a headache with items from the supermarket take echinacea receive an injection, or undertake a prescribed course of treatment to manage a serious illness.

In relation to the evaluation, assessment and monitoring done by the TGA, therapeutic goods are broadly defined as products for use in humans in connection with:

preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury influencing inhibiting or modifying a physiological process testing the susceptibility of persons to a disease or ailment influencing, controlling or preventing conception testing for pregnancy

This includes things that are:

used as an ingredient or component in the manufacture of therapeutic goods; or used to replace or modify of parts of the anatomy, or

Some products, even though they may technically meet the definition of a therapeutic good, are declared not to be therapeutic goods under section 7 of the Therapeutic Goods Act 1989. Information on these products is available on this website under the Therapeutic Goods (Excluded Goods) Order. Likewise some products that do not meet the definition of a therapeutic good can be declared to be therapeutic goods in order to allow the TGA to regulate them.

Is it a medicine or food?
How a product is presented can help to determine whether it will be treated as a food or a medicine. For example a clove of garlic is a food. However, if it is concentrated and marketed in capsule form with claims that it can be used to relieve cold and 'flu symptoms it will be treated as a medicine. A product's principal use is of primary consideration when determining whether it is a food or a medicine. Sometimes it can be quite difficult to determine if a product is a food or a medicine. In these cases it is best to contact the experts at the TGA or Food Standards Australia New Zealand.

Is it a therapeutic good or a cosmetic?

One of the main factors in determining whether a product is a cosmetic or a medicine (or a medical device) is the claims made about the product. For example, moisturisers which contain a sunscreening agent as a secondary component and have a stated therapeutic purpose (e.g. 'helps protect skin from the damaging effects of UV radiation') are medicines. Even if a product is intended for marketing as a cosmetic, it may be classified as a medicine this depends on:

its ingredients, the route of administration, or if therapeutic claims are made on its label, or in advertising.

Sometimes it can be quite difficult to determine if you product is a therapeutic good or a cosmetic. In these cases it is best to contact the experts at the TGA or the National Industrial Chemicals Notification and Assessment Scheme.

c. How the TGA regulates

Overview
The Australian community expects therapeutic goods in the marketplace to be safe, of high quality and of a standard at least equal to that of comparable countries. The TGA regulates therapeutic goods through:

pre-market assessment; post-market monitoring and enforcement of standards; and licensing of Australian manufacturers and verifying overseas manufacturers' compliance with the same standards as their Australian counterparts.

Therapeutic goods are divided broadly into two classes: medicines and medical devices. Medicines must be entered as either 'registered' or 'listed' medicines and medical devices must be 'included' on the Australian Register of Therapeutic Goods (ARTG) before they may be supplied in or exported from Australia, unless exempted. If a problem is discovered with a medicine, device or manufacturer, the TGA is able to take action. Possible regulatory actions vary from continued monitoring to withdrawing the product from the market.

Risk management
The TGA approves and regulates products based on an assessment of risks against benefits. All therapeutic goods have risks, some of which are insignificant, some serious. The TGA applies scientific and clinical expertise to its decision-making to ensure that the benefits of a product outweigh any risk. In assessing the level of risk, factors such as side effects, potential harm through prolonged use, toxicity and the seriousness of the medical condition for which the product is intended to be used, are all taken into account. For example, some blood pressure medications may include side effects such as a tickle in the throat or persistent cough, but this risk is outweighed by the proven benefits of reducing the risk of a heart attack or stroke. The level of TGA regulatory control increases with the level of risk the medicine or device can pose. Risk information is used by the TGA when deciding how to approve a medication for supply. For example, a low-risk product may be safely sold through supermarkets, while higherrisk products may only be supplied with a prescription.

The TGA's approach to risk management involves:

identifying, assessing and evaluating the risks posed by therapeutic products applying any measures necessary for treating the risks posed; and monitoring and reviewing risks over time.

The risk-benefit approach assures consumers that the products they take are safe for their intended use, while still providing access to products that are essential to their health needs.

d. Role of the sponsor

Under the Therapeutic Goods Act 1989, a 'Sponsor' is someone who:

imports therapeutic goods, manufactures therapeutic goods, has therapeutic goods imported or manufactured on their behalf, or exports therapeutic goods from Australia.

The sponsor of a medicine is the person or company responsible for applying to the TGA to have their medicine included in the Australian Register of Therapeutic Goods.

e. The TGA's risk management approach

12 September 2011 The Australian community has an expectation that therapeutic goods are safe and of high quality, to a standard equal to that in comparable countries. The objective of the Therapeutic Goods Act 1989 (the TG Act) is to provide a national framework for the regulation of therapeutic goods in Australia, so as to ensure their quality, safety, efficacy and timely availability. The Therapeutic Goods Administration (TGA), as part of the Australian Government Department of Health and Ageing, has responsibility for administering the TG Act. Essentially, any product for which therapeutic claims are made must be included in the Australian Register of Therapeutic Goods (ARTG) before it can be supplied in Australia. The exceptions to this requirement are if a product is subject to one of the limited exemptions set out in the legislation. The TGA adopts a risk management approach to regulating therapeutic goods. In essence, this means that the TGA:

identifies, assesses and evaluates the risks posed by therapeutic goods; applies any measures necessary for treating the risks posed; and monitors and reviews the risks over time.

The purpose of this document is to describe the broad risk management approach adopted by the TGA. It is intended that this document will be updated as the regulatory systems changes through future legislative amendments.

B. Australian Register of Therapeutic Goods

Related information

Searching the ARTG

Therapeutic goods must be entered on the Australian Register of Therapeutic Goods (ARTG) before they can be lawfully supplied in Australia.

Information held in the ARTG

Information held in the ARTG includes:

product name and formulation details sponsor (company) and manufacturer details

View public, sponsor or manufacturer information on the ARTG

There were approximately 62,600 products on the Australian Register of Therapeutic Goods as at January 2011.

Current medicines Current medical devices

Access to therapeutic goods not on the ARTG

As with many aspects of the regulatory framework, there are situations where special policies have been developed in response to the needs of particular people or circumstances. Information on these policies and the relevant procedures can be found at:

Special access scheme Authorised prescribers Personal import scheme Clinical trials exemption scheme

These schemes cannot be used to facilitate the commercial supply of therapeutic goods.

C. advertising therapeutic goods

Advertisements for therapeutic goods can be presented in several forms, including:

magazines newspapers television radio Internet Posters Billboards medical journals

Certain advertisements directed at consumers require approval prior to broadcast or publication. Advertising to consumers is permitted for the majority of medicines available for over the counter sale, while advertising prescription-only and certain pharmacist-only medicines to the general public is prohibited. (However, government-controlled public health campaigns that have been approved by Health Ministers are exempt from this prohibition). The advertising of therapeutic goods to consumers and health practitioners is controlled by a combination of statutory measures administered by the TGA and self-regulation through Codes of Practice administered by the relevant therapeutic goods industry associations. Advertisements for therapeutic goods in Australia are subject to the requirements of the Therapeutic Goods Act 1989 and Regulations, the Competition and Consumer Act 2010 and other relevant laws. Advertisements for therapeutic goods directed to consumers must also comply with the Therapeutic Goods Advertising Code. The purpose of these requirements is to protect public health by promoting the safe use of therapeutic goods, ensuring that they are honestly promoted as to their benefits, uses and effects. Further information, on Australia's co-regulatory system of advertising for therapeutic goods, including details of the Therapeutic Goods Advertising Code Council (TGACC), the Complaints Resolution Panel and the Complaints Register, may be obtained from the TGACC Internet site.

D. Labelling & packaging a. Labelling and packaging review

9 August 2011 The TGA is initiating a review of the labelling and packaging regulatory framework for prescription medicines, over the counter medicines and complementary medicines. The report Review to improve the transparency of the Therapeutic Goods Administration (TGA Transparency Review Report), contains recommendations relating to the labelling of medicines. The Gillard Government has yet to accept the recommendations. As part of the labelling and

packaging review, the TGA will be considering the submissions to the review and the relevant sections of the report. Subject to the outcomes of the government's consideration of the TGA Transparency Review Report, it is anticipated that the labelling and packaging review consultation paper will be released in October 2011.

b. A guide to labelling drugs and poisons

26 October 2007 The Standard for the Uniform Scheduling of Drugs and Poisons (SUSDP) contains certain legal requirements for the labelling of poisons and drugs that are for sale to the public. The labelling system it contains was initially designed to harmonise the requirements of Australia and New Zealand and was phased in over a five year period which commenced on 1 July 1995 and ended on 30 June 2000. In July 2004 the Required Advisory Statements for Medicine Labels (RASML) document was established by the Therapeutic Goods Administration to enable the transfer of all mandatory label advisory statements from the SUSDP and the Therapeutic Goods Regulations to a new document, separate from but linked to TGO 69 - General requirements for labels for medicines (the Labelling Order). The Labelling Order makes it mandatory for medicine labels to include any label advisory statements specified in Required Advisory Statements for Medicine Labels. The RASML provided a one-year transition period for existing products and took full effect on 1 July 2005. As a consequence the majority of SUSDP medicines advisory labelling requirements were replaced with references to the RASML, effective May 2006. This Guide has been prepared to assist manufacturers and packers of poisons to draft labels which comply with the SUSDP requirements as they exist on 1 January 2007. The information it contains is not complete nor is it intended to be the sole source of reference. It is essential for users of this Guide to also refer to the SUSDP and Commonwealth, State or Territory legislation which relate to the packaging and labelling of drugs, poisons, therapeutic goods, agricultural chemicals and veterinary chemicals. To assist the reader to refer back to the SUSDP, references to relevant paragraphs and sub-paragraphs have been included in this Guide.

c. Best Practice Guideline on Prescription Medicine Labelling

1. Space for the Pharmacist's Label

There should be a clear space for the pharmacist's dispensing label measuring a minimum of 80 x 40 mm. This is the size of the most commonly used computer-printed dispensing label. This means that after the pharmacist has labelled the package the following essential information will still be visible and that it should remain visible after the pharmacist has attached the dispensing label:

Batch number Expiry date Storage instructions

Product name Strength Name of the active ingredient(s) Dose form Barcode (EAN barcode) Signal headings Warning statements AUSTR number

If the product is packaged in a small container, such as eye drops, consideration should be given to use of a cardboard backboard that would allow space for a pharmacist's label. This should be on the primary container. Words to the effect 'Place label here' should be placed in the designated Pharmacy Label space. Ideally, if there are mandatory warning labels required, space should be provided.
2. Batch Number and Expiry Date

The batch number and expiry date should be positioned together and situated preferably on the end or side panel of the package. The batch number and expiry date should be easily legible; for example ink is preferred over embossing. For eye preparations and other topicals, the words "after opening use within [xx] days" should be on the label. See TGO for mandatory requirements. Top of page
3. Storage Conditions

Ideally, the storage conditions should be located close to the batch number and expiry date, and preferably on the front or side panels as end panels are already filled with product / active ingredient names and / or batch expiry information.
4. Barcode

An EAN barcode can be used to facilitate electronic aids in dispensing and as a means of doublechecking that this is the correct product to be dispensed. To be effective, it must be located so that it will not be covered by the pharmacist's dispensing label and can still be scanned after the pharmacist has affixed the dispensing label.
5. Product Name and Strength

Both the product name and the active ingredient names and strength should be prominently and equally displayed on the packet on at least three sides, including the two end panels. Strength and quantity should also be displayed. To assist in easy storage and reference both product and active ingredient names and strength / quantity should be displayed on end panels, with the first name alternating between the two end panels. To distinguish between the product name and the active

ingredient name, the first letter of the product name should be in upper case and of the active ingredient name in lower case with a different colour for each. Fonts may be used to differentiate, but all fonts should be clearly legible. There should be consistency in terminology to describe strength. All products in one product line should follow the same convention. The use of 5mg/5mL and 10mg/mL for two products in a product line is strongly discouraged. Expressions of strength should be consistent throughout all labelling, including Product Information (PI) and Consumer Medicine Information (CMI). See TGO for mandatory requirements.
6. Dose Form

Terminology concerning the long-acting dose forms should be accurate, relate to the product and be clearly specified on the label. For example, extended release, sustained release, controlled release or modified release are sometimes used.
7. Packaging Colour and Design

The use of colour and design should not unnecessarily clutter or obscure the message of the labels but make them clear and distinguishable. Pictures or graphics should be meaningful, appropriate, and represent the use of a medicine, and not suggest an unapproved use. Consideration should be given to including a graphical representation of the tablet on the outer packet. If using "corporate livery" companies should consider using other design elements (colour bands, positioning of text, boxes around text, reversed out printing) to assist distinguishing between products within their total product range and between different strengths and presentations. Use of different colours or colour bars to distinguish between different strengths or presentations of the product is encouraged. A visual signal may be given if stronger colours are used for higher strength products and light shades for lower strength products. If undertaking extensive changes to presentation, relevant user testing tailored to the needs of the particular user group is recommended. Top of page
8. Tamper-evident Packaging

The tamper-evident packaging should not interfere with the ability of the pharmacist to place the dispensing label.

9. Specific Australian Issues

Compliance with the following best practice recommendations will be taken by the TGA as acceptable: Potassium labelling: It is imperative that all concentrated potassium products for injection or infusion should be packaged in a manner that uniquely identifies them. The ampoules and vials should be clearly labelled as Potassium Chloride or the relevant salt; the end of the ampoules should contain "KCl", or equivalent, in large lettering. The strength is to be prominently displayed as both millimoles and total content and strength in millimoles/litre; the instruction, "dilute before use" should be included; there should be a black block of colour on the "twist off" tab at the top of the ampoule. In relation to the vial, there should be a black "twist off" seal on the cap of the vial. The premixed bags should only use red lettering for labelling. 'Potassium' should be in letters written vertically on the left hand side of the panel as well as horizontally, both in the largest font used on the label; concentration and content in millimoles should be displayed prominently and displayed next to the letters "Potassium". The words "Potassium chloride" (or equivalent) should also be displayed in large letters in the label. There should be a clear space at least equivalent to the maximum font size around main description and key information (such as diluent and volume). Vinca alkaloids: All products should be prominently labelled firstly with, "To be given intravenously only" followed by, "Fatal if given by any other routes". Methotrexate: Confusion has arisen because this product can be prescribed once weekly or sometimes at more frequent intervals in either the community or hospital setting. There should be clear instructions, "Check dose and frequency - methotrexate is usually taken once a week". Sponsors are encouraged to consider packaging methotrexate in indicationspecific weekly or daily packs to assist in reducing errors.
10. General issues

Consideration should be given to including a diagram or other visual depiction of the product, such as individual tablets/capsules etc, with identification codes, and/or a description on the outer pack. Avoid labels that easily detach from the container. See also TGO for mandatory requirements. To avoid ambiguity of the message, only positive statements should appear on medicine labels. For example, "For intravenous use only" is preferred to a negative statement such as "not for intravenous use".

Distinctive tablet markings may assist in identification of products and should be considered in product development. To distinguish between the product name and the active ingredient, the first letter of the product name should be in upper case and the first letter of the active ingredient should be in lower case. Consideration should be given to ensuring packaging is designed to meet the needs of intended recipients in terms of access.
11. Blister packaging

Ideally for blister packaging, each blister cover should include both the active and the product names, and the strength, batch number and expiry date of the medicine. However, this is not always possible. In cases where blisters are small, repetitive diagonal use of product names over the blister covers with expiry date and batch number on the side can assist with identification of partly used packs. High-risk dependency products, eg opioids & benzodiazepines, should be packed in blister packs where possible to facilitate accountability and reduce impulse ingestion. The use of gel caps should be avoided. Consideration should be given to packaging parenteral high risk dependency products in glass or otherwise take steps to reduce the risk of tampering.
12. Choice of product names

Product names for prescription medicines should clearly identify the product. They should be unique, but neither promotional nor offensive in relation to general community standards. Umbrella branding is strongly discouraged in prescription medicine labelling. The product name could be based on the active ingredient name with the company identified. Product names can be confused with other product names if care is not taken in their selection. In choosing a product name there should be comparative testing to existing product names, for both prescription and non-prescription medicines. This should involve a review using the letters forming the name, the sound of the name and analysis of recognition by electronic databases, as well as handwriting. Ideally, consumer and/or health professionals will be used in focus user testing and results provided to the TGA.
13. Combination products

For combination products, the names of all active ingredients should be used in equal prominence to the product name for the product itself. The product name of the product must be clearly differentiated from the product names for any of the ingredients. The quantities of the active ingredients should be clearly visible and may be incorporated in the product name. For product ranges, the quantities of the actives should be incorporated into the product name wherever possible, for example "XYZ 20/10". Alternatively, or in addition, the words "combination therapy" should be added under the product name.

14. New Line Products

If introducing new products to an existing range, consideration must be given to the potential for confusion with existing medicines. This may mean that not only will the new product have distinctive labelling, but revision of the existing product labelling may also be required.
15. Use of product names in other documents Consumer Medicine Information

The CMI should contain both active and product names at the beginning of the document. Use of product name is only encouraged where information relates to that product of the medicine. Use of active ingredient name for negative information only is not acceptable.
Product Information

The product name should not be used only to present positive information in the product labelling, nor the generic name used to present only negative information associated with the product. The product name should only be used where the information only applies to the characteristics of the branded product, for example, the description, form of presentation, strength, method of use and dosage.

E. Import & export

Importing therapeutic goods
Most products for which therapeutic claims are made must be listed or registered in the Australian Register of Therapeutic Goods (ARTG) before they can be supplied in Australia.

Exporting therapeutic goods

Safety and quality in medicines are not just a local matter. The increasing globalisation of trade means that our responsibilities continue beyond the limit of our territorial waters. The Therapeutic Goods Act 1989 applies to both the supply of therapeutic goods in Australia and the export of therapeutic goods from Australia. A key requirement of the legislation is that all therapeutic goods must be included in the Australian Register of Therapeutic Goods (ARTG), including those that are exported. There are processes and controls that you need to be aware of when applying to export therapeutic goods.

F. Cosmetics

The TGA only assesses cosmetic products that make therapeutic claims. Many ingredients in cosmetic products are classed as industrial chemicals and the National Industrial Chemicals Notification Assessment Scheme (NICNAS) must be notified of all cosmetics that contain industrial chemicals new to Australia. In September 2007, a new framework for the regulation of cosmetic products was implemented following amendments to the Industrial Chemicals (Notification and Assessment) Act 1989. This Act is administered by the National Industrial Chemicals Notification and Assessment Scheme (NICNAS). The Act legally underpins the Cosmetics Standard 2007 and this Standard is supported by the NICNAS Cosmetic Guidelines 2007. Both documents are available from the NICNAS website. To assist with facilitating this new regulatory framework, on 11 June 2008 the TGA adopted a new Therapeutic Goods (Excluded Goods) Order No. 1 of 2008. On 31 May 2011 Therapeutic Goods (Excluded Goods) Order No. 1 of 2008 was revoked by Therapeutic Goods (Excluded Goods) Order No. 1 of 2011. Enquiries about the regulation of cosmetic products should be directed to NICNAS in the first instance.

10. Committees A. Statutory expert committees

The TGA has six statutory expert committees it may call upon to obtain independent advice on scientific and technical matters. Committee members are appointed by the Minister and must have expertise in relevant clinical or scientific fields or appropriate consumer issues.

1. Advisory Committee on Complementary Medicines (ACCM)

Role of ACCM
The Advisory Committee on Complementary Medicines (ACCM) was formed in January 2010 to advise and make recommendations to the Therapeutic Goods Administration (TGA) on the inclusion, variation or retention of a complementary medicine in the Australian Register of Therapeutic Goods.

ACCM may also provide advice to the TGA on any other matters concerning complementary medicines, and any other matters referred to it by the TGA (whether or not related to a complementary medicine). ACCM supersedes the Complementary Medicines Evaluation Committee (CMEC) and has an increased focus on the advisory role within the regulatory framework of complementary medicines. A major role for ACCM is to provide scientific and policy advice relating to controls on the supply and use of complementary medicines in Australia. The ACCM provides this advice with particular reference to the safety and quality of products and, where appropriate, efficacy relating to the claims made for products.

2. Advisory Committee on Medical Devices (ACMD)

Role of ACMD
The Advisory Committee on Medical Devices (ACMD) provides independent medical and scientific advice to the Minister and the Therapeutic Goods Administration (TGA) on safety, quality and performance of medical devices supplied in Australia including issues relating to premarket conformity assessment and post market monitoring. The Committee is established under Regulation 38 of the Therapeutic Goods Regulations 1990 and the members are appointed by the Minister for Health and Ageing. On 1 January 2010 changes were made to the Therapeutic Goods Regulations 1990, which established the ACMD in place of the previous Committee, the Medical Devices Evaluation Committee.

3. Advisory Committee on Non-prescription Medicines (ACNM)

Role of ACNM
The Advisory Committee on Non-prescription Medicines (ACNM) was formed in January 2010. The ACNM advise and make recommendations to the TGA regarding the entry of nonprescription medicines on the Australian Register of Therapeutic Goods (the Register). This includes:

inclusion of a non-prescription medicine on the Register changes to an entry of a non-prescription medicine on the Register

removal or retention of a non-prescription medicine on the Register.

ACNM may also provide advice to the TGA on other matters concerning a non-prescription medicine, and any other matters referred to it by the TGA. The ACNM supersedes the Medicines Evaluation Committee (MEC).

4. Advisory Committee on Prescription Medicines (ACPM)

Role of ACPM
The Advisory Committee on Prescription Medicines (ACPM) was formed in January 2010. The ACPM advises and makes recommendations to the TGA on prescription medicines. This includes:

inclusion of a prescription medicine on the Australian Register of Therapeutic Goods (the Register) changes to an entry of a prescription medicine on the Register removal or retention of a prescription medicine on the Register.

ACPM may also provide advice to the Minister or the Secretary, through the TGA on other matters concerning a prescription medicine, and any other matters referred to it by the Minister or the Secretary. The ACPM is the successor of the Australian Drug Evaluation Committee (ADEC), which was formed in 1963.

5. Advisory Committee on the Safety of Medicines (ACSOM)

Role of ACSOM
The Advisory Committee on the Safety of Medicines (ACSOM) was formed in January 2010 to advise and make recommendations to the TGA on the:

safety of medicines risk assessment and risk management of medicines

ACSOM may also provide advice to the TGA on other matters related to the detection, assessment, understanding and prevention of adverse effects, known as pharmacovigilance, and any other matters referred to it by the TGA.

ACSOM supersedes and expands upon the role of the Adverse Drug Reactions Advisory Committee (ADRAC) with an increased focus on the safety aspects of medicine regulation and the detection, assessment, understanding and prevention of adverse effects. A major role for ACSOM is to provide advice on the quality and appropriateness of risk management plans which are designed to define and pro-actively manage risks relating to a medicine over its entire life cycle.

6. Therapeutic Goods Committee (TGC)

Role of the TGC
The Therapeutic Goods Committee (TGC) is established under regulation 34 of the Therapeutic Goods Regulations 1990 (the regulations) to advise and make recommendations to the Minister for Health and Ageing on the adoption of standards for therapeutic goods, matters relating to standards for therapeutic goods, including requirements for labelling and packaging and standards for manufacture of therapeutic goods, and matters relating to medical device standards and conformity assessment standards. For further details on the role and operation of the TGC, refer to the Therapeutic Goods Regulations 1990.

B. Other committees 1. Advisory committees on medicines & chemicals scheduling (ACMS & ACCS)
Role of the ACMS and the ACCS
Scheduling is a classification system that controls how medicines and chemicals are accessible to consumers. Medicines and chemicals are grouped into Schedules according to the appropriate level of regulatory control over their availability (e.g. Schedule 4 - medicines available only by prescription; Schedule 2 - medicines available over the counter in pharmacies). Under revised scheduling arrangements, which took effect on 1 July 2010, the Secretary to the Department of Health and Ageing (DoHA) (or the Secretary's delegate) superseded the National Drugs and Poisons Schedule Committee (NDPSC) as the decision maker for the scheduling of medicines and chemicals. The revised arrangements also established two expert advisory committees, the Advisory Committee on Medicines Scheduling (ACMS) and the Advisory Committee on Chemicals Scheduling (ACCS), as statutory committees under the Therapeutic Goods Act 1989 (the Act) to advise and make recommendations to the Secretary of the DoHA (or delegate) on the level of access required for medicines and chemicals.

2. Australian Influenza Vaccine Committee (AIVC) 3. National Coordinating Committee on Therapeutic Goods (NCCTG) 4. Regulatory and Technical Consultative Forum for medical devices (RegTech Forum) 11. TGA eBusiness services
TGA eBusiness Services (eBS) is an online portal that provides separate functions for consumers, health professionals and industry.

A. For Consumers and Health Professionals

eBS hosts the Australian Register of Therapeutic Goods (ARTG), and provides publically available information about current medicines and medical devices.

How to search the ARTG Current medicines Current medical devices

eBS offers an online reporting system for consumers and health professionals to report an adverse reaction to a medicine or medical device, and for industry to lodge a recall request for a deficient or defective medicine.

Report adverse drug reactions

eBS lists Consumer Medicines Information (CMI) and Product Information (PI) for public access and download.

A CMI is a leaflet that contains consumer information on the safe and effective use of a medicine. A PI provides health professionals with a summary of the essential scientific information to allow the safe and effective use of a medicine under nearly all circumstances.

B. For Industry
eBS allows industry to manage some therapeutic good registration applications, and view and cancel their current entries on the ARTG. Sponsors are able to view, download and print ARTG Register entries for their products and generate certificates online. Users are able to keep up to date with the latest TGA-wide and Industry specific news directly from the portal. eBS provides information on TGA approved Australian manufacturers and TGA approved ingredient names and terminology that can be used in online applications for therapeutic product entry onto the ARTG.

View approved terminology/code tables Australian manufacturers licensed to manufacture therapeutic goods

To apply for access to TGA eBusiness Services please see the eBS access forms, please note this access is only available to Industry, that is sponsors, agents or manufacturers.