Streamlining Regulatory Submission for Drug Development in Australia

Streamlining Regulatory Submission for Clinical Trials and Drug Development in Australia
Streamlining Regulatory Submission for Clinical Trials and Drug Development in Australia

Across the global landscape of pharmaceutical drug and medical device clinical trials, Australia has been internationally regarded for their high-quality clinical research output. As of 2021, the Australian Government Department of Health allotted nearly AUD$6.7 billion for investing in multiple facets of medical research, including clinical trials, through 2025. This country proactively recognizes that clinical trials and drug development in Australia are essential steps in the process of bringing new medications to the market.

However, considering the extensive research and testing these processes entail to ensure safety and efficacy, completing a regulatory submission can be a complex and time-consuming process. One of the features of the Australian clinical trial system that makes them a key contributor in global drug trials is their ongoing efforts to streamline the regulatory submission process to make it more efficient and effective. In this article, we describe Australia’s clinical trial system infrastructure, as well as how regulatory submission in Australia is changing to speed up drug development.

The Clinical Trial System in Australia

Australia has a well-established clinical trial system that is governed by the Therapeutic Goods Administration (TGA) also provides oversight and support to all clinical trials conducted in Australia. The TGA is a government agency that functions in a similar role as the Food and Drug Administration (FDA), Health Canada, and the European Medicines Agency (EMA).

The TGA is responsible for regulating therapeutic goods, including drugs, medical devices, and vaccines, to ensure that all therapeutic goods are safe and effective for human use. It also provides guidance and support to companies conducting clinical trials and drug development. All clinical trials must receive authorization from the TGA before supplying an investigational product for experimental use in humans. When conducting drug development in Australia, sponsors are required to determine whether their study needs to go through the Clinical Trial Notification (CTN) or Clinical Trial Approval (CTA) scheme. These applications must then undergo review by the TGA and/or a Health Research Ethics Committee (HREC) in Australia.

Benefits of Conducting Clinical Trials in Australia

Australia has consistently remained a key location considered by sponsors and their global contract research organization (CRO) partners when conducting a global drug development program. First and foremost, the TGA endorses mandatory compliance with ICH GCP guidelines for all Australian clinical trials involving unapproved drug products or medical devices. Because this ensures all Australian studies must adhere to the highest level of GCP standards, their clinical data are accepted by other global regulatory agencies, such as the FDA or EMA.

Another key advantage is Australia’s diverse population which can be representative of many ethnicities and ages. This diversity enables researchers to conduct clinical trials with a broad population base, making the results more applicable to the global population. Other benefits of Australia’s clinical trial landscape include the similarities of its healthcare system with those of the United States, Canada, and most of Europe, as well as existing government incentives which promote more industry involvement in R&D efforts.

Streamlining the Clinical Trial Process

Another significant advantage of conducting clinical trials in Australia is the TGA’s ongoing efforts to streamline the clinical trial process and create a pragmatic regulatory submission pathway for sponsors and CROs. One of the most significant changes has been the introduction of the Clinical Trial Notification (CTN) scheme, where the application is submitted directly to an Australian HREC to conduct both the scientific review and ethics review. Study approval through the CTN option typically only requires the submission of the research protocol, the investigator’s brochure, and an independent toxicology report if needed.

This scheme has simplified the regulatory process for low-risk clinical trials by removing the need for formal ethics approval. Unlike with the CTN option, the CTA scheme requires companies to include pre-clinical and clinical trial data, manufacturing information, and product labeling in their submission. In this case, the application undergoes scientific review by the TGA, then ethics review by an HREC, which comparatively requires more costly regulatory preparations and delays study start times.

Additionally, the TGA has implemented the Clinical Trial Research Agreement (CTRA) template. The CTRA template provides a standard agreement for clinical trial sponsors, investigators, and institutions, simplifying the contracting process and reducing the time it takes to initiate a clinical trial.

Streamlining the Regulatory Submission Process

The TGA has also made several changes to streamline the regulatory submission process for clinical trials and drug development in Australia. One of the most significant changes has been the implementation of the Priority Review pathway. This pathway is designed to fast-track the review of drugs that address a significant unmet medical need or provide a substantial improvement over existing medications. The Priority Review pathway can significantly reduce the time it takes for a life-saving drug to be approved for use in Australia.

A formal Provisional approval pathway has also now been implemented for drugs with preliminary clinical data that demonstrate potential for strongly benefiting Australian patients. Another change has been the implementation of the TGA’s Business Services Unit, which serves to provide support to companies conducting clinical trials and drug development. It helps to ensure that all necessary documentation is submitted correctly and in a timely manner, reducing the risk of delays in the regulatory submission process.

Optimization Efforts in Australia’s Clinical Trial System

In conclusion, the TGA’s efforts to streamline the regulatory submission process for clinical trials and drug development in Australia have been successful. In addition to the option for a single ethics review process, via the CTN scheme, the TGA has implemented the Priority Review pathway and the Business Services Unit to reduce the time it takes for drugs to be approved for use in Australia. As a result, clinical trials conducted in this country, whether for drugs or medical devices, can be established and started more quickly. These changes have made it easier for companies to conduct clinical trials and drug development in Australia, ultimately benefiting patients who rely on new medications to treat their medical conditions.

Vial is a global, full-service CRO headquartered in San Francisco, CA. Vial provides faster, more efficient clinical trial results at dramatically lower costs. Our CRO’s teams are committed to developing modern digital tools for streamlining today’s clinical trial experience for biotech sponsors around the world. To learn more about how Vial CRO’s regulatory experts can help you establish your next clinical trial, contact a team member today!

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