SME Assist 'Meeting Your Obligations' - Market authorisation

Hi, I'm Jayne Foster and I'm the Assistant Director of SME Assist at TGA.

Before we begin, I would like to acknowledge the traditional custodians of the lands on which I stand today and pay my respects to their Elders past, present and emerging.

I'm going to take you through some slides today which focus on 'Market Authorisation' to help you understand the process of getting approval to supply your therapeutic good.

These slides are a summary only and should not be taken as statements of law or policy in any way.

So this webinar on market authorisation is part of a series of webinars which provide more detail on the regulatory process for therapeutic goods.

Our other webinars focus on:

• manufacturing
• advertising, and
• post-market vigilance.

And these will help you navigate the 'regulatory maze'.

So in this webinar, I'm going to provide a general overview of the market authorisation process.

I will be covering therapeutic goods in general.

Look out for these icons on the slides.

• the icon on the left represents medicines and biologicals so when you see this icon, the information relates to both medicines and biologicals
• the icon on the right represents medical devices
• and if you see that icon at the bottom, this means the content relates to medicines, biologicals and medical devices.

We also have helpful 'i' symbols throughout the presentation and these link you to important information.

So let's look at the therapeutic goods development lifecycle. To supply any therapeutic good in Australia, you first have to get approval for market authorisation from TGA.

So you must consider the pre-market, processing and post-market stages as part of market authorisation.

Sponsors have numerous responsibilities at each of these stage. But for now, I'll focus on the information that you are likely to need to consider in your application. So the pre-market and processing stages.

1. So in the pre-market stage, this is where you compile data and information relating to things such as:
   • ingredients
   • manufacturing quality
   • and your labelling and packaging.
2. In the processing stage:
   • you will submit your online application and attach required data
   • evaluation and assessment is carried out
   • you will need to provide more data and information if we ask for it
   • and you will need to pay any associated application fees.
3. In the post-market stage:
   • you will need to provide data and information if we ask for it
   • report adverse events, safety issues, issues with manufacturing or ingredients, cancellations or transfer of sponsorship
   • you will need to conduct ongoing safety monitoring activities and develop periodic safety reports and risk management plans if applicable
   • you will need to comply with any conditions of registration or inclusion
   • and ensure all of your fees and charges are paid
   • note that there is another webinar in this series which covers post-market vigilance.

So subsidisation - TGA is not responsible for subsidisation of therapeutic goods. This is something that is carried out by our colleagues in the Department of Health.

For some products, you may be able to make applications to the Department for subsidy in parallel with your application to TGA for market authorisation. However, no pharmaceutical, prosthesis or Medicare listing will occur until the product is included in the Australian Register of Therapeutic Goods, or the ARTG. For more information, you should visit the Pharmaceutical Benefits Scheme, the Prostheses List Advisory Committee or the Medical Services Advisory Committee website.

And remember that TGA approval does not mean that your product will be subsidised.

So before you think about applying for market authorisation, you first have to determine whether your product is actually a therapeutic good.

TGA only regulates therapeutic goods – not cosmetics or food. So you need to know what kind of product you have.

For medicines:

• you might like to use our decision tool 'Is my product a therapeutic good?'
• you can also search the ARTG for similar products.

For medical devices:

• you could ask manufacturers about similar products
• you could also look at labels, instructions and advertising material
• you could also use the Is my product a therapeutic good? and What classification is my medical device? decision tool.

And, you could search the ARTG for similar products.

So note that all purple and green boxes on this slide are links.

If you identify your product as a therapeutic good, you can proceed with the market authorisation process.

Consult the Australian Regulatory Guidelines to determine what's required in the application process. All the different types of therapeutic goods have their own dedicated Guidelines document. These Guidelines are your go-to documents for finding out what you need to do when applying for market authorisation and complying with TGA requirements.

So these include:

• the ARGCM for complementary medicines
• the ARGOM for over-the-counter medicines
• the ARGPM for prescription medicines
• and the ARGB for biologicals
• and we also have the ARGMD for medical devices.

So where possible, TGA makes use of assessments from comparable overseas regulators, or CORs, and international assessment bodies in the regulation of medicines and medical devices.

This can reduce duplication of effort where an assessment has already been conducted outside Australia.

The criteria used to identify a comparable overseas regulator and the processes for using overseas assessments differ depending on the type of therapeutic good. It's important to note that TGA is still the decision-maker and the comparable overseas regulator must meet our defined criteria and processes.

When you're preparing your application for market authorisation, there are two critical areas that you need to take into consideration.

Firstly, what does your product contain?

This is mostly relevant to medicines and biologicals, but there are also some medical devices that deliver substances as well.

The ingredients contained in your product determine how stringently it is regulated.

Does it contain permissible ingredients? This is a list of ingredients that have been deemed to be of sufficient low risk.

Or, does it contain substances in the Poisons Standard. This is another list of ingredients that could be much higher risk.

Secondly, what claims are you making about your product?

Are you intending to make a general claim such as 'helps promote general health and wellbeing' or a claim that mentions a specific disease like 'diabetes'?

Generally, we regulate a product more stringently if it contains higher-risk ingredients, and makes higher level, disease-specific claims. For example, you will be required to compile and submit more evidence to demonstrate efficacy. The relevant Australian Regulatory Guidelines specify the kind of information you will need to provide about your ingredients and indications.

Therapeutic goods must be clearly labelled to ensure that consumers are given accurate information about the product.

For medicines and biologicals, labelling and packaging requirements depend on whether the medicine is prescription, non-prescription or a biological.

These requirements are set out in the Labelling Orders which are pieces of legislation.

Essential Principles specify the labelling requirements and instructions for use for medical devices.

The Medical Devices Regulations specify the sponsor information that needs to be included with medical devices.

Note that the Essential Principles are the criteria that need to be met to demonstrate that your device is safe to use.

When submitting your application, you will need to log in to your TGA Business Services, or TBS, account.

Note that for medical devices, you need to submit your manufacturer evidence and get your manufacturer approved before you submit your application for market authorisation.

Now let's look at a case study.

This is Alex. She would like to become a sponsor for a non-prescription medicine called 'Omega Breeze'.

Let's look at what she needs to consider when putting together a label for her medicine.

We're going to look at creating a non-prescription label using TGO 92. This labelling order will tell us the core information that needs to be on the label such as:

• the product name
• the batch number and expiry date
• storage conditions
• directions for use
• the address or contact for the sponsor
• the active ingredients
• and it also specifies how to display required information. The required text height must be greater than 1 mm. The AUST L here is too small; it must be larger.

Text must be clearly legible and the label must be durable.

In our example, the use of colour behind the active ingredients makes the text hard to see. And this would be considered a breach.

Our next step is to consider other legislation that may have an impact on our label.

In this example, we will look at the Permissible ingredients determination to see how this influences our label.

Let's start by looking at our krill oil ingredient, Euphausia superba oil.

We must consider if the ingredient itself has label requirements and we do this by looking at the permissible ingredients determination.

You can see a snap shot of this determination at the top of the slide.

The determination states we have to include the warning statement 'contains crustacean shellfish' or 'Derived from seafood'.

Looking at our label - we have already incorporated the warning 'contains crustacean shellfish' from TGO 92.

This warning is enough to satisfy both TGO 92 and the permissible ingredients determination.

We now need to include our indications on the label, or what the product will be used for.

The use of some indications will require label statements to also be included on the label.

Let's look at this permitted indication 'reduces common cold duration'. We need to check the Permissible indications determination to see if there are any requirements associated with its use.

Here's a snapshot of the permissible indications entry, it looks very similar to the permissible ingredients.

It has a few requirements for the label:

• we need to have an 'if symptoms persist…' statement
• and an 'adults only' statement.

We will have to add in those label statements.

As you can see, we've added the warning to our main warning section, and we've put the 'Adults only' warning up near the directions for use – making it compliant.

So you can see that you need to consult the relevant labelling orders as well as other relevant legislation to ensure everything is compliant.

Note that we haven't covered everything in this example. There is other legislation, such as the Advertising Code, that you also need to comply with.

I encourage you to visit the SME Assist hub on the TGA website. You can find this under the 'Industry' heading.

Here you will find guidance articles and decision tools for beginners on various topics including market authorisation.

These are our contact details and we look forward to hearing from you.

Thanks very much for your attention today. I hope that this webinar helps you better understand the market authorisation process.