Useful resources for business and researchers
Engaging with the TGA is only one part of your journey towards supplying a therapeutic good in Australia. As a small to medium business or researcher, you are likely to need advice and assistance from several others along the way. It is a good idea to become familiar with some of these avenues to build your own support network.
Before you engage with TGA, such as when you are considering conducting studies or clinical trials, you may be able to receive funding to support your innovation. You are also likely to require support after your therapeutic good is entered in the ARTG.
This page helps point you in the right direction of where you might go to receive support and information at different stages of the product lifecycle.
While we attempt to provide current and relevant information for small business on these webpages, please note that these lists are not exhaustive and we urge you to regularly consult with others outside TGA.
What would I like to find out about?
If you need more information about the regulation of therapeutic goods in Australia, you can find more resources on the TGA website.
Regulators
You may find it useful to investigate the requirements of other Australian regulators and the support provided by international regulators.
You may find that a number of different organisations are involved in regulating different aspects of your business.
- Australian Competition and Consumer Commission (ACCC) - external site
Implements competition and consumer policy. This includes issuing safety warnings, product bans or recalls where a product presents a potential public safety risk. - Australian health practitioner regulation agency (AHPRA) - external site
Responsible for the regulation of health practitioners. - Australian pesticides and veterinary medicines authority (APVMA) - external site
Regulates agricultural and veterinary chemicals and products containing them in Australia, up to and including, the point of retail sale. - Australian Taxation Office - external site
The principal revenue collection agency of the Australian government. - Department of Environment and Energy - external site
Regulates goods that might contain ingredients from threatened or endangered species. - Department of Immigration and Border Protection - external site
Responsible for Australian customs and border policy. - IP Australia - external site
Administers intellectual property (IP) rights and legislation relating to patents, trademarks, designs and plant breeder's rights. - National Industrial Chemicals Notification and Assessment Scheme (NICNAS) - external site
Assesses the risks of broad range of industrial chemicals used in inks, plastics, adhesives, paints, glues, solvents, cosmetics, soaps and many other products. - Office of Drug Control - external site
Regulates and provides advice on the import, export and manufacture of controlled drugs, as well as the cultivation of cannabis for medicinal purposes to support Australia's obligations under International Drug Conventions. - Office of the Gene Technology Regulator (OGTR) - external site
Identifies risk posed by or as a result of gene technology, and manages those risks by regulating certain dealings with genetically modified organisms (GMOs).
In Australia, the states and territories are important regulators.
- Food law implementation - external site
Australian state and territory governments implement and enforce the food standards developed by FSANZ through their respective laws. - Medicines and poisons regulation units
The implementation of the Poisons standard, as it affects access to and supply of medicines and poisons, is given legal effect through relevant State and Territory drugs, poisons and controlled substances legislation. - Workplace health and safety - external site
The Commonwealth, states and territories are responsible for regulating and enforcing the work health and safety laws in their jurisdictions.
Several international regulators of therapeutic goods offer targeted resources to assist small business.
- European Medicines Agency (EMA) - external site
Provides regulatory, financial and administrative assistance to small business via its dedicated SME office. - FDA Division of Industry and Consumer Education - external site
Answers questions from the medical device industry and helps the medical device industry understand FDA regulations and policies in the United States. - FDA CDER Small Business and Industry Assistance - external site
Offers various multimedia resources to provide information that is comprehensive, interactive, and easily accessible to small pharmaceutical business and industry. - Ireland's Health Products Regulatory Authority (HPRA) - external site
Provides regulatory support and advice to research and development centres as part of its commitment to supporting innovation. - Singapore Health Sciences Authority - external site
Singapore's national authority for the regulation of health products. - UK Medicines and Healthcare Products Regulations Agency (MHRA) - external site
Provides a single point of access to expert regulatory information, advice and guidance that helps organisations of all backgrounds and sizes develop innovative medicines, medical devices or novel manufacturing processes.
Funding opportunities
The Australian Government has funds, programs and initiatives in place to support innovation and business.
- Accelerating Commercialisation - external site
Provides access to grants and expert guidance to help businesses commercialise their novel products, processes and services. - Biomedical Translation Fund - external site
Invests in early stage companies that are developing biomedical innovations with commercialisation potential. - CSIRO Innovation Fund - external site
Invests in commercialisation of early stage innovations to help them become successful businesses. This includes start-up companies and SMEs engaged in the translation of their research. - Department of Industry, Innovation and Science - Business and startups - external site
Supports a wide range of initiatives and provides information on current government policy, programs, grants and projects. - Entrepreneurs' Programme - external site
Provides practical support to businesses, researchers and entrepreneurs such as advice, grants and funding to help them find growth opportunities and improve their competitiveness. - Incubator Support Initiative - external site
Assists incubators (business support organisations) that encourage innovative start-ups focused on international trade and provides expert advisers for start-ups to improve the chance of commercial success in international markets. - Global Connections Fund (GCF) - external site
Provides support to Australian researcher and SME collaborations with grants to increase linkages, promote researcher-industry engagement and encourage translational activities. - BioMedTech Horizons (BMTH) - external site
An initiative delivered by MTPConnect to support innovative collaborative health technologies, drive discoveries towards proof-of-concept and commercialisation that address key health challenges as well as maximise entrepreneurship and idea potential. - Australian Postgraduate Research Intern (APR.Intern) - external site
A national platform for businesses to connect with PhD research talent - from all Australian universities - and accelerate innovation through a 3 to 5 month research project with a Government Rebate available for Australian businesses. - GrantConnect - external site
Provides centralised publication of forecast and current Australian Government grant opportunities and grants awarded.
- Australian Research Council (ARC) funding - external site
Funds research and researchers under the National Competitive Grants Program (NCGP). - Medical Research Commercialisation Fund (MRCF) - external site
Provides dedicated investment funding to support the commercialisation of early-stage medical research discoveries that originate from its member institutes. The collaborative nature of the MRCF seeks to foster best practice in the commercialisation of medical innovations. - Medical Research Future Fund (MRFF) - external site
Provides financial assistance to support health and medical research and innovation, to improve the health and well-being of Australians. - National Health and Medical Research Council (NHMRC) Grants - external site
Provide funding for one to three years to support individual researchers, research teams, or a health and medical research company in partnership with researchers to undertake research at the early proof-of-principle or pre-seed stage. - NHMRC and research translation - external site
Supports effective and rapid translation of research findings into health care policy and practice. - NHMRC career development fellowships - external site
Support researchers to spend one to two years of their aware research time in an industry placement (Australia or overseas). It aims to help bridge the gap between research and industry.
- National Foundation for Medical Research and Innovation (NFMRI) - external site
Seeks to partner with biomedical researchers and donors to identify, evaluate and support innovative and high quality research projects with identified impact objectives.
New South Wales
- NSW Medical Devices Fund - external site
Helps encourage and support investment in the development and commercialisation of medical devices in NSW, to accelerate the development of medical devices by removing barriers to commercialisation, and to leverage other funding. - NSW Health - Application kit and guidelines - external site
Contains information on grants available through the Medical Devices Fund, the application and assessment process and reporting and accountability requirements.
Northern Territory
- Business innovation support initiatives (BISI) - external site
Helps Northern Territory businesses in areas of science, engineering, technology and design undertake research and development which could lead to new products, processes or services.
Queensland
- Queensland business development fund - external site
Helps to turn ideas into reality with co-investment in Queensland businesses at the forefront of commercialising ground-breaking research or innovations.
South Australia
- Innovation Voucher Program - external site
Stimulates innovation in small to medium enterprises by collaborating with public and private research providers to develop new manufactured products or processes and drive productivity and business profitability. - TechInSA - external site
Works closely with industry to assist South Australia's entrepreneurs and innovative organisations looking to commercialise novel products and services. It offers start-ups and early stage companies grants, business and marketing assistance, lab and office space, and access to global networks.
Tasmania
- Business.tas.gov.au - external site
Grants are available for expanding your business, innovation, exporting, and research and development.
Victoria
- Business Victoria - external site
Offers various grants, vouchers and assistance programs that can help start, run and grow a business.
Access to research facilities and training
- ACRF Drug Discovery Centre - external site
Supports Australian drug discovery research, providing the cancer and medical research community with access to advanced technology and expertise in high-throughput chemical small molecule screening and early stage drug discovery. - CellBank Australia - external site
Operated by Children's Medical Research Institute in Westmead, Sydney and is Australia's only national cell line repository, providing Australian scientists with ready access to validated cell lines and associated quality control services. - Children's cancer centre tissue bank - external site
Comprises a collection of tissues from paediatric patients linked to health information and is a world-class resource for researchers studying childhood and adolescent/young adult cancer. - Compounds Australia - external site
Enables drug discovery research projects across universities, research institutes and biotech industry within Australia. It offers a variety of services in compound management and logistics using a cost recovery and fee-for-service model. - Therapeutic Innovation Australia - external site
Provides subsidised access to translational health research infrastructure and general product development advice. This includes the Pipeline Navigator, an innovative online map of Australian translational research providers; and the Pipeline Accelerator, a scheme that provides access and support funding to SMEs and research groups. - Victorian platform technologies network - external site
Provide state-of-the-art research infrastructure and expertise to the biomedical, health and manufacturing technology research sector throughout Australia and around the world. Some of the technologies and services include bioinformatics, genomics and microscopy. - Innovative Manufacturing Accelerator Program - external site
Launched by the New Venture Institute to provide project assistance to manufacturing companies through skill development, specialist advice and access to resources at Flinders University.
- Australian clinical trials - external site
Contains information on ethics processes, principles of research conduct, regulatory considerations and research governance. Researchers initiating clinical trials in Australia must attend to trial design, resource issues, ethics review, regulatory oversight, institutional policies, research governance and many other issues. - Australian New Zealand clinical trial registry - external site
Online registry of clinical trials being undertaken in Australia, New Zealand and worldwide. It accepts trials for registration from all countries and from the full spectrum of therapeutic areas including trials of pharmaceuticals, surgical procedures and complementary therapies.
For those interested in studies relevant to therapeutic goods regulation, the following are some of the relevant Australian tertiary programs:
- UNSW - Master of Pharmaceutical Medicine - external site
- University of New England - Graduate Certificate or Masters in Regulatory Science - external site
- University of Sydney - Master of Medicine (Pharmaceutical and Medical Device Development) - external site
- University of Wollongong - Graduate Certificate in Regulatory Science - external site
Tools and support for business
There are a number of Australian organisations that provide tools and support for small business.
- AusIndustry - external site
Helps small businesses access the right information and advice to develop and commercialise their ideas and products. - AusTrade - external site
Provides information, advice and services to advance Australia's international trade, education, investment and tourism interests. - Efic (finance for Australian exporters) - external site
Delivers solutions for Australian companies when their bank is unable to help; aims to enable small businesses by helping them to win business, grow internationally and achieve export success. - Innovation Connections - external site
Offers accessible advice, assistance and tailored support to small and medium businesses to improve business capability and competitiveness. - Support to help your small business grow - external site
To help you find government initiatives and support that can drive growth and success in your small business, check out the Business.gov.au online tool. The tool lists a full range of initiatives and support available for your small business all in one place. - Tax incentives for investors - external site
Information about incentives provided by the Australian Taxation Office that encourage investors to support innovative, high-growth potential startups in Australia. - CSIRO SME Connect - external site
Facilitates partnerships between Australian SMEs and the research sector through support and funding programs, including CSIRO Kick-Start, Innovation Connections and STEM+ Business.
- Advanced Manufacturing Growth Centre - external site
Supports the development of a world-leading advanced manufacturing sector in Australia. - MTP Connect - external site
Aims to accelerate the rate of growth of the medical technologies, biotechnologies and pharmaceuticals sector.
Australian Capital Territory
- Innovate Canberra - external site
Provides a range of programs and support to the ACT business community.
New South Wales
- Innovate, University of New South Wales - external site
Brings researchers and industry together. Small businesses can tap into the university's resources such as their laboratories and technologies to help develop innovative products and services. Their website also provides case studies where you can see how such partnerships have helped turn research discoveries into successful products and services.
Queensland
- Advance Queensland - external site
Is a suite of programs, based on international evidence of 'what works', designed to create the knowledge-based jobs of the future. - QLD University of Technology bridge program - external site
Selects 100 participants annually across Australia to take part in face-to-face and online training in the scientific, legal, financial, clinical, regulatory and reimbursement disciplines that contribute to research translation and the commercialisation of medicines. - Translational Research Institute, Queensland - external site
Combines clinical and translational research to advance progress from laboratory discovery to application in the community. - UniQuest - external site
Is the main commercialisation company of the University of Queensland and specialises in industry-university collaborations, global technology transfer, and provides access to world-class expertise, intellectual property and facilities.
South Australia
- Medical Device Partnering Program (MDPP), Flinders University - external site
Supports development of cutting-edge medical devices by bringing together researchers, industry, end-users and government. It provides a mechanism for the development of prototypes, proof of concept and/or commercialisation planning for potential Australian medical device products.
Tasmania
- Enterprise Centres Tasmania - external site
Provides independent business advisors to help small businesses reach their potential.
Western Australia
- Western Australia Innovation - external site
Support services and programs for the innovation community to help get ideas up and running
- Texas Medical Center accelerator - external site
Provides start-up companies with shared workspace, a curriculum tailored to the needs of healthcare entrepreneurs and the guidance of over 120 advisors from the front lines of the industry.
Peak bodies represent a sector of the industry.
- Accord - external site
Represents manufacturers and suppliers of hygiene, cosmetic and specialty products, their raw material suppliers and service providers. - Active Pharmaceutical Ingredient Manufacturer's Association of Australia (APIMAA) - external site
Promotes the interests of API manufacturers in Australia and represents the API industry in government policy development. - ARCS Australia - external site
Enables the highest quality development and utilisation of medicines and medical technology by facilitating the professional development and connectivity of people involved these areas. - Association of Therapeutic Goods Consultants - external site
A networking body for consultants in Australia and New Zealand, providing technical advice for sponsors and manufacturers of medicines and medical devices for human use. - AusBiotech - external site
Provides representation and services to promote the global growth of Australian biotechnology. - Australian Dental Industry Association (ADIA) - external site
Represents suppliers of products and services to dental professionals. - Australian Medical Manufacturers and Distributors Association (AMMDA) - external site
Represents the medical technologies sector in the development of government policy. - Australian New Zealand Industrial Gas Association (ANZIGA) - external site
An independent organisation representing companies that produce and distribute industrial gases for the industrial, medical, food, scientific and hospitality markets in Australia and New Zealand. - Australian Self Medication Industry (ASMI) - external site
Represents companies involved in the manufacture and distribution of non-prescription healthcare products. - Complementary Medicines Australia (CMA) - external site
Committed to a vital and sustainable complementary healthcare products industry. - Generics and Biosimilars Medicines Association (GBMA) - external site
Represents generic and biosimilar medicine suppliers in Australia. - IVD Australia - external site
Represents Australian sponsors and manufacturers of in vitro diagnostics. - Life Sciences Queensland - external site
Works to assist the growth of individual firms and organisations, and build the profile, capacity and capability of the sector to ensure long term economic, social and environmental benefits to Queensland. - Medical Technology Association of Australia (MTAA) - external site
Represents companies in the medical technology industry. - Medicines Australia (MA) - external site
Represents Australia's discovery-driven pharmaceutical industry.
- Regulatory Affairs Consultants
Offer services, including advice and assistance, relating to regulatory requirements.
Subsidy and reimbursement
You may wish to investigate how to make your goods more affordable to the consumer through these subsidy and reimbursement schemes.
- Medical Benefits Schedule (MBS) - external site
List of Medicare services subsidised by the Australian government. - Pharmaceutical Benefits Scheme (PBS) - external site
An Australian Government program that subsidises the cost of medicines for Australians. - Private health insurance - external site
Medicare does not subsidise all therapeutic goods. Australians can choose to take out private health insurance that provides a wider range of health care options and cover for some medicines and medical devices. - Prostheses List - external site
List of surgically implanted prostheses, human tissue items and other medical devices that private health insurers must pay benefits for when they are provided to a patient with appropriate health insurance cover as part of hospital treatment or hospital substitute treatment, and there is a Medicare benefit payable for the professional service.
Upcoming events relevant to business
Research and training are important components of developing new business opportunities.
- MTP Connect calendar of events - external site
MTP Connect maintains a calendar of events for the medical technologies, biotechnologies and pharmaceuticals sector. - TGA events
Search the TGA Events dataset for future events.