When to engage with the TGA

Foundation

9 June 2017

There are many reasons you may need to engage with the TGA. This can include meeting your obligations if you are already a sponsor of a therapeutic good, reporting information to the TGA on the safety, efficacy and quality of a product, and where you might be seeking for a product to be authorised for use in Australia.

This page provides some information to help you understand at what point you should engage with us, especially where you are considering:

  • seeking approval to import, export, manufacture or supply a therapeutic good in Australia
  • conducting research related to a therapeutic good that is not currently registered for use in Australia

Engage early

There is no rule about how early you should engage with the TGA.

If you are conducting research with a product for which therapeutic claims are made, or have a product that is likely to be considered a therapeutic good, familiarising yourself with our website and understanding the steps and pathways for market authorisation is a good idea.

By the time you are applying for a therapeutic good to be entered in the Australian Register of Therapeutic Goods (ARTG), you should already be looking at our website.

Much of your engagement with us is likely to be online. You might access information through our website, make applications through TGA Business Services, pay fees or charges, or report adverse events or report issues that might result in a therapeutic goods recall.

You can also contact us directly by email or phone.

We recommend that you seek to understand what is required, including the costs, before applying for marketing authorisation or importing or manufacturing a therapeutic good. Remember that there might be considerable costs associated with obtaining information and remaining compliant.

If you do not meet your legal obligations in supplying therapeutic goods, you may be subject to civil and criminal penalties.

What we can't help you with

TGA regulates therapeutic goods only. We do not regulate:

  • veterinary medicines
  • food
  • health insurance
  • cosmetics
  • chemicals
  • healthcare professionals
  • clinical practice

If you would like more information on how any of these are regulated, you can find the contact details of a number of regulatory agencies on our website.

Risk-based regulation throughout the product lifecycle

All therapeutic goods pose some potential risk. Our regulatory role means we apply scientific and clinical expertise to decision-making to ensure that the potential benefits of a medicine, medical device or other therapeutic good outweigh the possible risks.

If you are a sponsor or manufacturer of therapeutic goods, you will need to engage with us throughout the life of the therapeutic good. It is up to you to ensure you understand when you will need to make contact with us to meet your regulatory requirements.

For example, this may include when you:

  • are preparing material before making an application
  • submit an application related to manufacture or the ARTG
  • receive a request for information from us
  • need to report a suspected or actual adverse event with a medicine or medical device
  • need to report a medicine shortage
  • become aware of an issue associated with manufacturing the therapeutic good, or ingredients or components of the product

If you or your company either are, or intend to:

  • export therapeutic goods from Australia
  • import therapeutic goods into Australia
  • manufacture therapeutic goods for supply within Australia or elsewhere
  • arrange for the import, export or manufacture of therapeutic goods

then you may be a sponsor of therapeutic goods. You can find out more about being a sponsor on our website. You can also watch our video explaining your responsibilities as a sponsor of therapeutic goods.

Are you a manufacturer (or considering becoming one)?

You may be (or intend to be) a manufacturer of a medicine, biological or other therapeutic good, or you may manufacture medical devices (including in vitro diagnostic (IVD) medical devices). You can find out more about being a manufacturer on our website.

If you manufacture, or intend to manufacture, a medicine, biological or other therapeutic good within Australia you must have a current licence to manufacture therapeutic goods. If you manufacture medicines, biologicals or other therapeutic goods overseas, a sponsor must have appropriate good manufacturing practice (GMP) certification or clearance.

If you manufacture medical devices (including IVDs), the level of conformity assessment required matches the level and nature of the risks associated with the use of the device. Self-assessment by the manufacturer is acceptable for low risk devices, whereas for the highest risk devices an assessment of the manufacturer's quality management system and examination of the design of the specific device by a conformity assessment body is required.

Where to begin

The TGA offers a range of resources to help you navigate your journey with us. Keep in mind that engaging with the TGA is only one part of your journey towards supplying a therapeutic good in Australia. Please see useful resources for SMEs to find out more about:

  • funding opportunities and support
  • conducting research
  • independent regulatory advice
  • other useful information

Our information for industry is a great place to start familiarising yourself with your role and responsibilities as a sponsor or manufacturer.

TGA Business Services

TGA Business Services (TBS) is our electronic business services portal. If you are a sponsor or a manufacturer, you will need a client ID before you can access TGA Business Services.

Once registered, additional organisation details will need to be completed by the account's Administrator.

You can use the TGA Business Services to:

  • apply to have a good entered in the ARTG
  • access information related to your applications and ARTG entries
  • submit clinical trial notifications
  • advise us of adverse events or recalls
  • view and cancel your current ARTG entries and generate certificates
  • review paid and unpaid invoices
  • payment of outstanding invoices

Before the good is entered in the ARTG

Pre-submission meetings

In certain circumstances, it may be appropriate that you have a pre-submission meeting with us. For more information, including when we recommend this, see the pre-submission meeting guidance.

Entering a therapeutic good in the ARTG

If you wish to supply a therapeutic good within Australia you need to apply to have that good entered in the ARTG (with very limited exceptions where an exemption applies). This can be done via the TGA Business Services portal.

There are fees and charges associated with your application to enter a good in the ARTG.

After the good is entered in the ARTG

If your request to enter the therapeutic good in the ARTG is approved, you become the sponsor, and you have ongoing legal responsibilities associated with that good. These responsibilities include:

  • obtaining information from the manufacturer and providing this to TGA upon request
  • ensuring that the product's manufacturer meets the relevant regulatory requirements, such as:
    • holding a relevant manufacturing licence (Australian medicine and biologicals manufacturers)
    • having GMP clearance (overseas medicine manufacturers)
    • having an appropriate conformity assessment certification (medical devices)
  • paying any ongoing charges associated with maintaining the ARTG entry
  • notifying or requesting changes to the therapeutic good if necessary
  • complying with any conditions imposed on supply or advertising of the good
  • recording supply of the good
  • notifying TGA of adverse events and adverse reactions associated with the sponsored good
  • advising TGA of the need to recall a product
  • recalling the product, if necessary

If you do not meet these requirements, both civil and criminal penalties might apply.

You can find more information about your responsibilities as a sponsor in the Australian regulatory guidelines for each type of therapeutic goods - see guidelines for:

Post market monitoring and surveillance

Ongoing monitoring of medicines, biologicals and medical devices once they are approved for use in Australia is an important part of ensuring safety, efficacy and quality of therapeutic goods used in Australia.

You can find out more about your responsibilities for post market monitoring for medicines, monitoring for biologicals and medical devices safety monitoring on our website.

Advertising

We regulate the advertising of therapeutic goods. Only certain therapeutic goods are allowed to be advertised to consumers, and advertising includes the pictures you use on the label. You are also limited in the claims you can make for your therapeutic good. You can find out more about your responsibilities around therapeutic goods advertising on our website.

Maintaining your contact details

You need to ensure we have your correct contact details. The TGA will at times need to contact you and if it is unable to do so your ARTG entry may be cancelled. You can keep your contact details up to date via TGA Business Services.

Maintaining your ARTG entry

You also need to keep your ARTG entry up-to-date and ensure it is correct. This includes updating any changes to your product as a result of manufacturing changes. For more information on maintaining your ARTG entry, see the guidance specific to your product type on our website.

Recalls

If there is an issue with the safety, quality, efficacy, performance or presentation of a therapeutic good, it may be necessary to recall the good to resolve the issue. You can find more information about recalls on our website.

Case studies

Case study 1: Claudia the herbalist.

Claudia is a herbalist. She gave her mother the herb Claudius claudium while her mother was fighting cancer. Claudia is convinced that Claudius claudium helped her mother fight the cancer and is considering manufacturing and selling Claudius claudium tablets to help cancer sufferers.

Claudia wants to know more and has looked at the TGA website to find out whether the tablets would be considered a therapeutic good, and is pretty sure they would be. However, Claudia is reluctant to proceed to an application before she understands the law around supplying medicines. She checks the TGA website to find out more about what she will need to consider before she decides to proceed further.

Other products on the ARTG

Claudia decides it would be a clever idea to check the ARTG on the TGA website to see if there are already listed or registered medicines containing Claudius claudium. There are none.

Approved or new substance

Claudia wants to know whether Claudius claudium is an approved ingredient for listed medicines. Claudia looks up the Therapeutic Goods (Permissible Ingredients)Determination No 2 2017 and finds that Claudius claudium is not on the list. This means Claudia would need to make an application for a new substance before she could use Claudius claudium in a listed medicine. Claudia finds the data requirements for a new substance described in the Australian regulatory guidelines for complementary medicines (ARGCM) on the TGA website.

Evidence for therapeutic claims

Next, Claudia looks at the Guidelines on the evidence required to support indications for listed complementary medicines. She learns that making a high-level claim like helping cancer patients must be supported by considerable evidence and Claudia does not have access to clinical trial data. Claudia also realises that the medicine would need to be registered, not listed, so the application process would be more expensive and require much more data than the listing process. Claudia decides not to proceed.


Case study 2: Frank the importer

Frank saw a new kind of sling for limb sprains and breaks while he was overseas, and he would like to import these slings into Australia.

Frank has no experience in importing therapeutic goods. When he returns to Australia, he visits the TGA website and discovers that the sling is a medical device and that he needs to become a sponsor and make an application for an ARTG entry under his name before importing it into Australia.

Frank investigates further and learns that to make his application he needs to obtain from the manufacturer the Global Medical Device Nomenclature (GMDN) code and the Australian classification. He also finds that it would be a good idea to obtain from the manufacturer a Declaration of Conformity; for low risk medical devices this can be a self-assessment by the manufacturer.

Frank begins discussions with the manufacturer to obtain the necessary information, ensure they have the appropriate certificates and is able to properly monitor the device after marketing it (meet all ongoing legislative requirements). He develops an ongoing business relationship with the manufacturer to ensure that he will receive updates related to safety issues.

Becoming a sponsor

Frank fills out the organisation details form to obtain access to TGA Business Services. He applies to enter the medical device in the ARTG and become its sponsor.

Frank notes that there are usually both fees and charges, but for a Class I medical device he will not need to pay an application or assessment fee. However, he notes that once he starts supplying the device he will need to pay an annual charge to the TGA.

TGA approves Frank's application. Frank is now the medical device sponsor and is able to import the sling into Australia for supply and sale. Frank reads all the relevant guidance on the TGA website to ensure that he understands his responsibilities as a sponsor and can meet them.


Case study 3: Andrew the researcher

Andrew has been conducting research on chemicals produced by coral for several years. He has identified three chemicals that have specificity for three separate human receptors. Andrew thinks that at least one of these compounds might be a useful medicine in the future. As he considers future research grants, collaborations and potential industry support, he decides to find out what studies would be required for an application to the TGA for a new prescription medicine.

Guidelines useful for designing studies

Andrew discovers that the TGA adopts international guidelines as a basis for the technical data requirements for applications to register prescription medicines in Australia. He learns that if he would like the findings of his studies to be useful in a registration application, it would be a good idea to comply with Good Laboratory Practice. He also learns that there are guidelines specific to quality studies and nonclinical studies, as well as guidelines about clinical efficacy and safety on the TGA website.

Clinical trial information

Andrew is interested in eventually conducting clinical trials and looked up the NHMRC and found the Australian Clinical Trials website. He was happy to discover that this website contained comprehensive information for researchers about clinical trials, including links to various TGA web pages such as the Australian clinical trial handbook.