Overview of applying for market authorisation

Foundation

9 June 2017

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).

This information provides an overview of the various steps involved when applying for market authorisation. It is intended for those who are new to therapeutic goods regulation. It is also intended to guide researchers who are developing new innovative products. Please make sure you have read:

The process varies depending on your therapeutic good

If you are a person or organisation applying for market authorisation, you are known as the applicant. If market authorisation is granted, you become known as the sponsor.

As the sponsor, you are also the one who:

  • obtains the ARTG entry
  • bears all associated responsibilities
  • is financially liable for the good

If you are importing a therapeutic good from overseas with the intention to supply, you are the one who needs to apply for ARTG entry, and you are the one with the responsibilities that belong to a sponsor.

How you apply for and obtain market authorisation depends on the type of 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.

Our website describes the specific steps needed for market authorisation, depending on your therapeutic good:

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

  1. Pre-market
    • You, the applicant, compile the required data and information pertaining to your therapeutic good. Note that for some lower risk therapeutic goods you will not have to compile any data at this stage.
  2. Processing
    • You submit your application for market authorisation via our online system.
    • We screen your application to make sure the right data and information has been provided.
    • If you were required to provide pre-market data, we assess the data.
    • If your therapeutic good meets our regulation requirements, we grant you market authorisation and enter your therapeutic good to the ARTG.
  3. Post-market
    • As the sponsor, you must fulfil a number of responsibilities and obligations for your therapeutic good to remain on the ARTG.
    • Your therapeutic good could be randomly selected or targeted for post-market review.

Supporting data

The use of all therapeutic goods needs to be supported by data relating to:

  • quality
  • safety
  • efficacy or performance

During the pre- or post-market stages, you may be requested to generate or provide data about your therapeutic good. For example, you could be required to provide data pertaining to the good's safety, or to support an advertising claim you've made. It just depends on what type of good it is, but we'll let you know when that information is required.

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 entered on 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. Where we ask for data during post-market review, you will need to provide it to us.

Sometimes we ask you to generate a significant amount of data (for example, if the therapeutic good is new and unlike any other therapeutic good on 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.

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.

Your online account

Once you have compiled the data required of you, you can submit your application.

You will need to have an account on our online system, TGA Business Services (TBS). Please ensure that you:

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. Then, if pre-market data has been provided, we assess your data 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 need more data before we can make a decision, so we will request it from you. It is a condition of ARTG entry that you supply us with the information we request.

It is vital to note that regardless of whether we assess data first, we continue to monitor the therapeutic good after it is entered on the ARTG (post-market), and as the sponsor you are responsible for holding and providing all 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 stands regardless of whether you are importing, exporting or supplying a therapeutic good.

Decision

We will inform you of our decision once assessment is complete.

If we decide that the benefits outweigh the risks, and that the therapeutic good meets all regulatory requirements, you will be granted market authorisation and your therapeutic good will be entered on the ARTG.

Otherwise, we will provide you with a statement of reasons for our decision and what recourse may be available to you (such as a review of the decision).

Ongoing responsibilities

As a sponsor, you have ongoing responsibilities while your therapeutic goods are included on the ARTG. For more information:

Your therapeutic good could be randomly selected or targeted for a post-market review, in which case we will contact you and request data.

Payment

You will need to pay an initial application fee whose amount will vary depending on the type of therapeutic good. Sometimes you'll 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, you may lose your ARTG entry. All new ARTG entries are eligible for the annual charge exemption (ACE) scheme.

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

  • The TGA has 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

Other relevant information

Regulatory affairs consultants offer advice, assistance and other services related to regulatory requirements. For more information: Regulatory affairs consultants