Never wavering from our collaborative and patient-centred approach, we help guide organisations both big and small towards meaningful outcomes that have a tangible and measurable impact on the future of human health. Another important way we do this is through Regulatory Affairs team, and more specifically — delivering Market Authorisation.

With over 50 successful marketing applications completed, 12 IND/IDE submissions and 350+ Device Approvals, let’s unpack what it takes to fast-track your market authorisation and some of the key benefits of working with a local sponsor like Accelagen for your post-trial needs.

Navigating the local market

Ranked in the Top 5 for biotech innovation and data outputs, studies conducted in Australia are regularly accepted by international regulatory authorities, including the FDA and EMA.

And while the regulatory environment and processes are arguably the same or even more stringent than in other markets such as the US and EU, more and more, companies are choosing to to seek marketing authorisation here. So, how do you get your product to market as efficiently as possible?

National regulations

Market authorisation is the approval given to supply a therapeutic good in Australia, but it’s not a case of simply ‘plug and play’ what has worked in the US, European or other Asia-Pacific markets.

Here, we have a two-tiered system for the regulation of medicines, all of which must be entered into the Australian Register of Therapeutic Goods (‘ARTG’) — an electronic register of therapeutic goods that can be lawfully supplied in Australia.

How you apply for and obtain market authorisation depends on the type and/or classification of your therapeutic good. In general, the process consists of three stages:

1. Pre-market

• You, the applicant, compile the required data and information required for your therapeutic good.

2. Processing

• Submit your application to be assessed and, if following a rigorous review process your product is deemed to meets national regulatory requirements for quality, safety and efficacy, you are granted 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)

However, what happens if you do not have a local presence? This is where Accelagen comes in. We can act as a local Australian sponsor and Marketing Authorisation Holder (MAH), giving you an inside track to take advantage of this country’s world-leading Healthcare Infrastructure for your strategic goals.

Fulfilling your regulatory obligations 

Australia is known for having a comparatively streamlined regulatory review process. Yet, without an intimate knowledge of our system and its key players, you might not know how to achieve a seamless market authorisation.

Establishing a formal entity can be complex and time consuming. One of the main reasons we are engaged to act as a local sponsor with global clients is because we know the system like the back of our hands. This not only ensures that all regulatory obligations are fulfilled, but that you are working with a company that can adeptly navigate a system that may be foreign or unwieldy, without you having to open a local office or employ local staff.

Time and cost-effective for better commercial outcomes

Gaining market authorisation for a new product is often a significant commercial undertaking. Every delay costs time — for you, and for the end users who stand to benefit from your life-changing research. Delays also have a habit of blowing out your budget and eroding profitability and any commercial gains.

How we work to ensure better commercial outcomes is by starting with the ‘end’ in mind. In other words, we get clear on the strategic objectives you want to achieve and what success looks like to you, and then we chart a regulatory pathway to market authorisation for maximum success with minimum headaches.

Keeping your stakeholders happy

Founded by a values-driven and passionate senior regulatory affairs and clinical development professional in Greg Plunkett, our expertise is widely varied across the health, wellness and disease spectrum.

At Accelagen, we offer best-in-class and in-house regulatory affairs, to ensure we can minimise friction and create seamless pathways to market authorisation. Our team works closely with the regulators, sharing knowledge and insights across internal departments and creating efficiency for you every step of the way.

“One of the main reasons we engage Accelagen as our local sponsor in Australia is that they do everything in-house. We have noticed a significant decrease in our time to market by working with them, which keeps all stakeholders positive and engaged. And we enjoy cost-saving from not having to set up an operation in Australia, being based in India ourselves.”
— MSN Group, Hyderabad, India

Want to work with Accelagen?

As your local regulatory partner, Accelagen can:

• Identify key aspects of your data that may impact review timelines
• Help navigate the regulatory pathways and identify opportunities for expedited approvals
• Support and maintain regulatory approval on your behalf
• Ensure a more cost-effective and compliant outcome
  
  

With experience sponsoring regulatory submissions with partners from every region, including Asia-Pacific, North America and Europe, we’d love to talk more about being your local sponsor in the growing Australian market.

Learn more and get in touch today: https://accelagen.com.au/services/regulatory-affairs/market-authorisation/