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Overview of applying for market authorisation

Overview of the process to follow if you want to supply therapeutic goods in Australia.

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Market authorisation is the approval given to supply a therapeutic good in Australia, and, in most cases, involves entry on the Australian Register of Therapeutic Goods (ARTG).

The ARTG is an electronic register of therapeutic goods, which can be lawfully supplied in Australia.

This page provides an overview of the various steps involved when applying for market authorisation. It is for those who are new to supplying therapeutic goods in Australia and for researchers who are developing new innovative products.

If you're very new to the TGA and regulation, we recommend you view our Regulation Basics page before you start.

SME Assist also offers free 'Meeting your Obligations' workshops that are designed with SMEs and those new to regulation in mind. You can subscribe to our SME email list to stay up to date with when the next workshop will be held.

The market authorisation process

How you apply for, obtain and costs associated with market authorisation depend on the type and/or classification of your therapeutic good. The steps, and the level of information you need to provide when applying, also depend on the risk level of your therapeutic good.

See Product regulation according to risk for more information.

In general, the market authorisation process consists of three stages:

  1. Pre-market
    • You, the applicant, compile the required data and information required for your therapeutic good.
  2. Processing
    • You submit your application for market authorisation through TGA Business Services (TBS)
    • Your application is assessed to ensure the required information has been provided (noting that this is an automated process for listed medicines and some medical devices)
    • If your therapeutic good meets our regulatory requirements, we grant you market authorisation and your therapeutic good is included in the ARTG and you are known as the sponsor
  3. Post-market
    • As the sponsor, you must fulfil a number of responsibilities and obligations for your therapeutic whilst it remains in the ARTG (such as reporting adverse events)
    • Your therapeutic good may be randomly selected or targeted for a post-market review (depending on the type of therapeutic good)

See our recorded SME Assist Market authorisation presentation from our 'Meeting Your Obligations' workshop for an overview.

Payment

You will need to pay an initial application fee with the amount varying depending on the type of therapeutic good. Sometimes you will need to pay an additional evaluation or assessment fee to cover the cost of us assessing your therapeutic good.

To maintain your therapeutic good's ARTG entry, you will need to pay an annual charge. If you do not pay the charge, your product may be cancelled from the ARTG. All new ARTG entries are eligible for the Annual Charge Exemption (ACE) scheme.

There may also be other fees payable throughout the lifetime of your therapeutic good, including those to change the ARTG entry. For more information, refer to Summary of fees and charges.

It is important to be aware that:

  • there are both fees and charges
  • a fee is charged for a service, such as an evaluation/assessment
  • a charge is a form of tax imposed on the regulated industry and is applied annually based on a 1 July to 30 June financial year

Pre-market

Supporting data

Therapeutic goods need to be supported by data relating to:

  • quality
  • safety
  • efficacy or performance

During the pre- or post-market stages, you may receive a request from us to provide data about your therapeutic good. For example, you may be required to provide data pertaining to the good's safety, or to support an indication you have made.

An Indication (registered medicines, listed medicines, Class 3 and 4 biologicals), intended use (Class 2 biologicals), and intended purpose(medical devices) are words used to describe the specific therapeutic use of a product.

In most cases, we will ask for data during the pre-market stage.

The exception is lower risk therapeutic goods (such as listed medicines, the majority of Class I devices that are not an IVD or Class 1 IVD devices), which can be included in the ARTG without us having to assess any data. However, you will be required to provide a legal declaration that you are able to provide this information upon request.

Sometimes we ask you to provide a significant amount of data (for example, if the therapeutic good is new and unlike any other therapeutic good in the ARTG). Note that if the data is already in the public domain, you will not need to generate new data, but you will need to be able to provide it if requested.

You will need evidence of efficacy (for medicines and biologicals) or performance (for medical devices).

You can find more information in the:

Manufacturing quality

All medicines and biologicals need to be manufactured according to our regulatory requirements. This (with a small number of exceptions) includes meeting Good Manufacturing Practice (GMP). As the sponsor, you will need evidence that the manufacture complies with GMP.

All medical device manufacturers need to comply with the requirements for conformity assessments in order to demonstrate that their devices comply with the Essential Principles. As the sponsor, you will need evidence of compliance.

Guidance

The TGA website provides detailed information required to obtain market authorisation for your type of therapeutic good, including evidence, labelling and indication or claim requirements:

You also have responsibilities and restrictions associated with advertising your therapeutic good once it is on the market. See our Advertising hub early to ensure your product complies with advertising.

Processing

Your online account

Once you have compiled the data required for your therapeutic good, you can submit your application.

You will need to have a TGA Business Services (TBS) account to apply.

To do this:

Assessment of data

First, we screen your application to make sure all the required data and information is included and correct.

In some cases (such as for Class I medical devices and complementary medicines), this may occur as part of the automatic inclusion process.

If pre-market data is provided as part of your application, we assess this to check whether the benefits outweigh the risks, and that the therapeutic good meets all regulatory requirements.

There are different factors (including the risk level of your therapeutic good) that can impact on:

  • how much data (and what data) we need to assess
  • when we assess this data

Sometimes we may request further data before we can make a decision. Strict timeframes are associated with these requests for information and must be adhered to. It is a condition of ARTG entry that you supply us with requested information.

It is important to note that regardless of whether we assess data first, we continue to monitor the therapeutic good after it is included in the ARTG (post-market).

It is your responsibility as the sponsor to hold and provide all of the information we need to assess and review your therapeutic good. If this requires you to obtain information from another party (such as a manufacturer), this is your responsibility, including any agreements with the other party to do so.

This requirement applies regardless of whether you are importing, exporting or supplying a therapeutic good.

Decision

We will inform you of our decision once assessment is complete. We contact you through the details you have supplied in TBS, make sure these are always up to date. Consider providing a general email that many people can access, so correspondence from the TGA is not missed if someone is away or sick.

If we decide that the benefits outweigh the risks and that the therapeutic good meets all regulatory requirements, you are granted market authorisation and your therapeutic good is included in the ARTG.

If market authorisation is not granted, we will provide you with the reasons for our decision and what recourse may be available to you, such as a review of the decision.

Post-market

Ongoing responsibilities

As a sponsor, you have ongoing responsibilities while your therapeutic good remains in the ARTG. For more information:

SME Assist's Meeting your Obligation workshop - free workshops aimed at helping those unfamiliar with regulation understand their obligations as a sponsor

Post-market reviews

Your therapeutic good can be randomly selected, or targeted for a post-market review to ensure compliance. Remember that it is the sponsor's responsibility to remain compliant with any relevant legislation.

We will typically contact you with a formal request for information to assess data you have provided, need to hold (but did not need to provide to us as part of market authorisation) or might be missing, incomplete or unclear.

We can also target-review any advertising of your therapeutic good. Often this stems from investigating complaints received about advertising.

For more information consult the relevant guidance for your therapeutic good and also see:

Other relevant information

Regulatory affairs consultants can offer advice, specific assistance and other services related to regulatory requirements. You can find more information at Regulatory affairs consultants.

Product types