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Useful resources for business
Building a support network
Engaging with the TGA is only one part of your journey towards supplying a therapeutic good in Australia. As a small to medium business, 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.
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)
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)
Responsible for the regulation of health practitioners.
- Australian pesticides and veterinary medicines authority (APVMA)
Regulates agricultural and veterinary chemicals and products containing them in Australia, up to and including, the point of retail sale.
- Australian Taxation Office
The principal revenue collection agency of the Australian government.
- Department of Environment and Energy
Regulates goods that might contain ingredients from threatened or endangered species.
- Department of Immigration and Border Protection
Responsible for Australian customs and border policy.
- IP Australia
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)
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
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)
Identifies risk posed by or as a result of gene technology, and manages those risks by regulating certain dealings with genetically modified organisms (GMOs).
State and territory regulators
In Australia, the states and territories are important regulators.
- Food law implementation
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
The Commonwealth, states and territories are responsible for regulating and enforcing the work health and safety laws in their jurisdictions.
International therapeutic goods regulators
Several international regulators of therapeutic goods offer targeted resources to assist small business.
- European Medicines Agency (EMA)
Provides regulatory, financial and administrative assistance to small business via its dedicated SME office.
- FDA Division of Industry and Consumer Education
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
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)
Provides regulatory support and advice to research and development centres as part of its commitment to supporting innovation.
- Singapore Health Sciences Authority
Singapore's national authority for the regulation of health products.
- UK Medicines and Healthcare Products Regulations Agency (MHRA)
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.
Australian Government innovation and business funding
The Australian Government has funds, programs and initiatives in place to support innovation and business.
- Accelerating Commercialisation
Provides access to grants and expert guidance to help businesses commercialise their novel products, processes and services.
- Biomedical Translation Fund
Invests in early stage companies that are developing biomedical innovations with commercialisation potential.
- CSIRO Innovation Fund
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
Supports a wide range of initiatives and provides information on current government policy, programs, grants and projects.
- Entrepreneurs' Programme
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
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)
Provides support to Australian researcher and SME collaborations with grants to increase linkages, promote researcher-industry engagement and encourage translational activities.
Australian government research funding
- Australian Research Council (ARC) funding
Funds research and researchers under the National Competitive Grants Program (NCGP).
- Medical Research Commercialisation Fund (MRCF)
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)
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
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
Supports effective and rapid translation of research findings into health care policy and practice.
- NHMRC career development fellowships
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.
Other research funding
- National Foundation for Medical Research and Innovation (NFMRI)
Seeks to partner with biomedical researchers and donors to identify, evaluate and support innovative and high quality research projects with identified impact objectives.
State and territory funding
New South Wales
NSW Medical Devices Fund
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
Contains information on grants available through the Medical Devices Fund, the application and assessment process and reporting and accountability requirements.
Business innovation support initiatives (BISI)
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 business development fund
Helps to turn ideas into reality with co-investment in Queensland businesses at the forefront of commercialising ground-breaking research or innovations.
- Innovation Voucher Program
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.
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.
Grants are available for expanding your business, innovation, exporting, and research and development.
Offers various grants, vouchers and assistance programs that can help start, run and grow a business.
Access to research facilities and training
Access to researchers and facilities
- ACRF Drug Discovery Centre
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
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
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
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
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
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
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.
Clinical trials information
- Australian clinical trials
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
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.
Relevant tertiary training programs
For those interested in studies relevant to therapeutic goods regulation, the following are some of the relevant Australian tertiary programs:
Tools and support for business
There are a number of Australian organisations that provide tools and support for small business.
Australian Government support
Helps small businesses access the right information and advice to develop and commercialise their ideas and products.
Provides information, advice and services to advance Australia's international trade, education, investment and tourism interests.
- Efic (finance for Australian exporters)
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
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
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
Information about incentives provided by the Australian Taxation Office that encourage investors to support innovative, high-growth potential startups in Australia.
- CSIRO SME Connect
Facilitates partnerships between Australian SMEs and the research sector through support and funding programs, including CSIRO Kick-Start, Innovation Connections and STEM+ Business.
Australian industry growth centres
State and territory support programs
Australian Capital Territory
Provides a range of programs and support to the ACT business community.
New South Wales
Innovate, University of New South Wales
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.
- Advance Queensland
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
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
Combines clinical and translational research to advance progress from laboratory discovery to application in the community.
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.
Medical Device Partnering Program (MDPP), Flinders University
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.
Enterprise Centres Tasmania
Provides independent business advisors to help small businesses reach their potential.
Western Australia Innovation
Support services and programs for the innovation community to help get ideas up and running
Texas Medical Center accelerator
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.
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)
Promotes the interests of API manufacturers in Australia and represents the API industry in government policy development.
- ARCS Australia
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
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.
Provides representation and services to promote the global growth of Australian biotechnology.
- Australian Dental Industry Association (ADIA)
Represents suppliers of products and services to dental professionals.
- Australian Medical Manufacturers and Distributors Association (AMMDA)
Represents the medical technologies sector in the development of government policy.
- Australian New Zealand Industrial Gas Association (ANZIGA)
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)
Represents companies involved in the manufacture and distribution of non-prescription healthcare products.
- Complementary Medicines Australia (CMA)
Committed to a vital and sustainable complementary healthcare products industry.
- Generics and Biosimilars Medicines Association (GBMA)
Represents generic and biosimilar medicine suppliers in Australia.
- IVD Australia
Represents Australian sponsors and manufacturers of in vitro diagnostics.
- Life Sciences Queensland
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)
Represents companies in the medical technology industry.
- Medicines Australia (MA)
Represents Australia's discovery-driven pharmaceutical industry.
Independent regulatory advice
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)
List of Medicare services subsidised by the Australian government.
- Pharmaceutical Benefits Scheme (PBS)
An Australian Government program that subsidises the cost of medicines for Australians.
- Private health insurance
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
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.