Useful resources for business

Foundation

Building a support network

9 June 2017

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.

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.

Several international regulators of therapeutic goods offer targeted resources to assist small business.

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 – Support for small business
    Supports a wide range of initiatives and detailed information on current government policy, programs, grants and projects in relation to small business.
  • 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.

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.

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.
  • TechInSA
    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.

Business.tas.gov.au
Grants are available for expanding your business, innovation, exporting, and research and development.

Business Victoria
Offers various grants, vouchers and assistance programs that can help start, run and grow a business.

  • 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, general product development advice and can direct researchers to relevant service providers.
  • 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.
  • 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.

There are a number of Australian organisations that provide tools and support for small business.

  • AusIndustry
    Helps small businesses access the right information and advice to develop and commercialise their ideas and products.
  • AusTrade
    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.
  • Advanced Manufacturing Growth Centre
    Supports the development of a world-leading advanced manufacturing sector in Australia.
  • MTP Connect
    Aims to accelerate the rate of growth of the medical technologies, biotechnologies and pharmaceuticals sector.

Innovate Canberra
Provides a range of programs and support to the ACT business community.

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.
  • UniQuest
    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.

Regulatory Affairs Consultants
Offer services, including advice and assistance, relating to regulatory requirements.

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.

Research and training are important components of developing new business opportunities.