Australia: TGA future business processes on complementary medicines open for discussion

Last Updated: 15 October 2017
Article by Dean Gerakiteys

Most Read Contributor in Australia, October 2017

A standardised process for pre-market assessments of complementary medicines with legislated timeframes and fee structures could be on the way.

As part of the continuing reform of the Australian therapeutic goods regulatory framework, the Therapeutic Goods Administration (TGA) has released a further consultation paper, seeking the views of consumers, health professionals and sponsors on the development and implementation of a range of proposed business processes aimed at improving the regulation of complementary medicines in Australia. Responses are requested by 7 November 2017.

Broadly, comments are invited on the following issues:

  • business processes for pre-market assessment including legislated assessment timeframes and proposed fee structures for applications requiring evaluation;
  • the introduction of risk-based application categories for the pre-market evaluation of complementary medicines;
  • criteria to apply to the acceptance of reports from comparable overseas regulators and sources of evidence for de novo assessment; and
  • strategies to enhance the post-market monitoring and compliance scheme for listed medicines.

Business processes for pre-market assessments including legislated assessment timeframes and proposed fee structures for applications requiring evaluation

The TGA is proposing to introduce a standardised process for pre-market assessments with legislated timeframes and fee structures. The TGA has illustrated the proposed process:

Complementary medicines listed in the "standard" manner, that is, that use only permitted indications, will continue to be listed on the basis of self-assessment/certification.

Each step of the process is detailed further as part of the consultation. Notably:

  • an application fee and evaluation fee will apply. The application fee is payable on submission, and purportedly reflects the administrative costs associated with an application, whereas the evaluation fee will cover the cost of assessing the supporting information in an application. The latter is only payable at "Screening", that is once an application is deemed to meet the minimum requirements to proceed to "Evaluation";
  • "Evaluation" may involve requests for information seeking further clarification. These requests will not however afford an applicant an opportunity to supply information that should have been originally included
  • as part of the "Decision", the delegate will consider the evaluation report as well as any advice provided by an advisory committee and any subsequent comment provided by the applicant.

In support of this process a new fee structure is proposed, reflective of the level of risk of a new or varied complementary medicine and the level of scrutiny required to be undertaken by the TGA for the purposes of the pre-market assessment. At this stage, the TGA has provided initial estimates of the proposed Application and Evaluation fees. The proposed Application fees range from $430 for a listed assessed medicine in the lowest applicable category to $2,770 for a new registered complementary medicine in the highest category, while the proposed Evaluation fees for the same goods range from $1,640 to $35,500.

The proposed timeframes for each of the various assessment pathways range from:

  • 70 to 180 working days for complementary medicine ingredients;
  • 45 to 150 working days for assessed listed medicines; and
  • 45 to 210 working days for registered complementary medicines.

The TGA is seeking feedback on these proposed business processes for pre-market assessments including both the proposed fee structures and legislated timeframes.

Risk-based application categories

The TGA also proposes the introduction of risk-based application categories in the pre-market evaluation of complementary medicines. It is proposed that these application categories will sit within each of the pre-market assessment processes to apply to complementary medicines, namely:

  • new ingredients to be used in listed medicines;
  • assessed listed medicines; and
  • registered medicines.

It is envisaged that applications submitted in the lower risk categories will require less supporting information.

The TGA is seeking feedback on the proposed categories underlying each pre-market assessment as part of this consultation.

Criteria for acceptance of reports from comparable overseas regulators and sources of evidence for de novo assessments

The TGA has detailed the criteria it proposes using to determine whether reports from comparable overseas regulators are able to be relied upon by sponsors for the purposes of applications for assessment. The criteria have been designed to be applied through a two-stage process:

  • firstly, the preliminary criteria that will be used to determine if there is sufficient similarity between the TGA and the overseas regulator; and
  • secondly, the parameters that the TGA will consider to determine the suitability of evaluation reports from overseas regulators at the time of submission.

The TGA has also detailed the criteria it proposes be applied to alternative sources of evidence for de novo assessments.

The TGA is seeking feedback on both the criteria for acceptance of reports from comparable overseas regulators and sources of evidence for de novo assessments, which are set out in further detail in the consultation paper.

Enhanced post-market compliance monitoring scheme for listed medicines

The TGA has expressed concerns about the level of non-compliance by sponsors of listed medicines and has proposed three strategies to address this issue:

  • Targeting of non-compliant sponsors. The TGA has noted that currently sponsors may withdraw their product from the ARTG following a request for information for a compliance review, only to later relist their medicine so as to avoid a possible negative finding. The TGA proposes disincentivising this behaviour by targeting such sponsors for post-market compliance review for multiple listed medicines, at least until such time as, in the opinion of the TGA, the sponsor's behaviours and actions improve. The TGA also proposes penalising sponsors who repeatedly demonstrate a clear intention to circumvent their obligations. The example given is the use of infringement notices for repeat offenders;
  • Improving transparency about compliance review outcomes. The TGA proposes providing more detailed information about products that are the subject of a compliance review, including the compliance issues identified during any such review, the actions taken by the sponsor in response; and/or if the product is cancelled, details as to the reasons why the product was cancelled. The TGA acknowledges that this will involve a balancing act between consumer protection and the protection of commercial information and procedural fairness; and
  • Education and resources for product sponsors. The TGA proposes educating sponsors with better tools and resources to improve their understanding of their regulatory obligations.

The TGA is seeking feedback on the measures proposed above, including the educative tools that may result in greater compliance.


Clayton Utz communications are intended to provide commentary and general information. They should not be relied upon as legal advice. Formal legal advice should be sought in particular transactions or on matters of interest arising from this bulletin. Persons listed may not be admitted in all states and territories.

To print this article, all you need is to be registered on

Click to Login as an existing user or Register so you can print this article.

Some comments from our readers…
“The articles are extremely timely and highly applicable”
“I often find critical information not available elsewhere”
“As in-house counsel, Mondaq’s service is of great value”

Up-coming Events Search
Font Size:
Mondaq on Twitter
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).
Email Address
Company Name
Confirm Password
Mondaq Topics -- Select your Interests
 Law Performance
 Law Practice
 Media & IT
 Real Estate
 Wealth Mgt
Asia Pacific
European Union
Latin America
Middle East
United States
Worldwide Updates
Check to state you have read and
agree to our Terms and Conditions

Terms & Conditions and Privacy Statement (the Website) is owned and managed by Mondaq Ltd and as a user you are granted a non-exclusive, revocable license to access the Website under its terms and conditions of use. Your use of the Website constitutes your agreement to the following terms and conditions of use. Mondaq Ltd may terminate your use of the Website if you are in breach of these terms and conditions or if Mondaq Ltd decides to terminate your license of use for whatever reason.

Use of

You may use the Website but are required to register as a user if you wish to read the full text of the content and articles available (the Content). You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these terms & conditions or with the prior written consent of Mondaq Ltd. You may not use electronic or other means to extract details or information about’s content, users or contributors in order to offer them any services or products which compete directly or indirectly with Mondaq Ltd’s services and products.


Mondaq Ltd and/or its respective suppliers make no representations about the suitability of the information contained in the documents and related graphics published on this server for any purpose. All such documents and related graphics are provided "as is" without warranty of any kind. Mondaq Ltd and/or its respective suppliers hereby disclaim all warranties and conditions with regard to this information, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. In no event shall Mondaq Ltd and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use or performance of information available from this server.

The documents and related graphics published on this server could include technical inaccuracies or typographical errors. Changes are periodically added to the information herein. Mondaq Ltd and/or its respective suppliers may make improvements and/or changes in the product(s) and/or the program(s) described herein at any time.


Mondaq Ltd requires you to register and provide information that personally identifies you, including what sort of information you are interested in, for three primary purposes:

  • To allow you to personalize the Mondaq websites you are visiting.
  • To enable features such as password reminder, newsletter alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our information providers who provide information free for your use.

Mondaq (and its affiliate sites) do not sell or provide your details to third parties other than information providers. The reason we provide our information providers with this information is so that they can measure the response their articles are receiving and provide you with information about their products and services.

If you do not want us to provide your name and email address you may opt out by clicking here .

If you do not wish to receive any future announcements of products and services offered by Mondaq by clicking here .

Information Collection and Use

We require site users to register with Mondaq (and its affiliate sites) to view the free information on the site. We also collect information from our users at several different points on the websites: this is so that we can customise the sites according to individual usage, provide 'session-aware' functionality, and ensure that content is acquired and developed appropriately. This gives us an overall picture of our user profiles, which in turn shows to our Editorial Contributors the type of person they are reaching by posting articles on Mondaq (and its affiliate sites) – meaning more free content for registered users.

We are only able to provide the material on the Mondaq (and its affiliate sites) site free to site visitors because we can pass on information about the pages that users are viewing and the personal information users provide to us (e.g. email addresses) to reputable contributing firms such as law firms who author those pages. We do not sell or rent information to anyone else other than the authors of those pages, who may change from time to time. Should you wish us not to disclose your details to any of these parties, please tick the box above or tick the box marked "Opt out of Registration Information Disclosure" on the Your Profile page. We and our author organisations may only contact you via email or other means if you allow us to do so. Users can opt out of contact when they register on the site, or send an email to with “no disclosure” in the subject heading

Mondaq News Alerts

In order to receive Mondaq News Alerts, users have to complete a separate registration form. This is a personalised service where users choose regions and topics of interest and we send it only to those users who have requested it. Users can stop receiving these Alerts by going to the Mondaq News Alerts page and deselecting all interest areas. In the same way users can amend their personal preferences to add or remove subject areas.


A cookie is a small text file written to a user’s hard drive that contains an identifying user number. The cookies do not contain any personal information about users. We use the cookie so users do not have to log in every time they use the service and the cookie will automatically expire if you do not visit the Mondaq website (or its affiliate sites) for 12 months. We also use the cookie to personalise a user's experience of the site (for example to show information specific to a user's region). As the Mondaq sites are fully personalised and cookies are essential to its core technology the site will function unpredictably with browsers that do not support cookies - or where cookies are disabled (in these circumstances we advise you to attempt to locate the information you require elsewhere on the web). However if you are concerned about the presence of a Mondaq cookie on your machine you can also choose to expire the cookie immediately (remove it) by selecting the 'Log Off' menu option as the last thing you do when you use the site.

Some of our business partners may use cookies on our site (for example, advertisers). However, we have no access to or control over these cookies and we are not aware of any at present that do so.

Log Files

We use IP addresses to analyse trends, administer the site, track movement, and gather broad demographic information for aggregate use. IP addresses are not linked to personally identifiable information.


This web site contains links to other sites. Please be aware that Mondaq (or its affiliate sites) are not responsible for the privacy practices of such other sites. We encourage our users to be aware when they leave our site and to read the privacy statements of these third party sites. This privacy statement applies solely to information collected by this Web site.

Surveys & Contests

From time-to-time our site requests information from users via surveys or contests. Participation in these surveys or contests is completely voluntary and the user therefore has a choice whether or not to disclose any information requested. Information requested may include contact information (such as name and delivery address), and demographic information (such as postcode, age level). Contact information will be used to notify the winners and award prizes. Survey information will be used for purposes of monitoring or improving the functionality of the site.


If a user elects to use our referral service for informing a friend about our site, we ask them for the friend’s name and email address. Mondaq stores this information and may contact the friend to invite them to register with Mondaq, but they will not be contacted more than once. The friend may contact Mondaq to request the removal of this information from our database.


From time to time Mondaq may send you emails promoting Mondaq services including new services. You may opt out of receiving such emails by clicking below.

*** If you do not wish to receive any future announcements of services offered by Mondaq you may opt out by clicking here .


This website takes every reasonable precaution to protect our users’ information. When users submit sensitive information via the website, your information is protected using firewalls and other security technology. If you have any questions about the security at our website, you can send an email to

Correcting/Updating Personal Information

If a user’s personally identifiable information changes (such as postcode), or if a user no longer desires our service, we will endeavour to provide a way to correct, update or remove that user’s personal data provided to us. This can usually be done at the “Your Profile” page or by sending an email to

Notification of Changes

If we decide to change our Terms & Conditions or Privacy Policy, we will post those changes on our site so our users are always aware of what information we collect, how we use it, and under what circumstances, if any, we disclose it. If at any point we decide to use personally identifiable information in a manner different from that stated at the time it was collected, we will notify users by way of an email. Users will have a choice as to whether or not we use their information in this different manner. We will use information in accordance with the privacy policy under which the information was collected.

How to contact Mondaq

You can contact us with comments or queries at

If for some reason you believe Mondaq Ltd. has not adhered to these principles, please notify us by e-mail at and we will use commercially reasonable efforts to determine and correct the problem promptly.