Six ways to register a medicine in Australia: Understanding the complexities of medicine registration.
In the dynamic landscape of pharmaceuticals, securing registration for a new medicine requires a nuanced understanding of regulatory procedures and individual client needs. The process involves meticulous planning and strategic vision to ensure successful registration. However, beyond the intricacies of registration, lies the broader imperative of positioning the activities within a global context.
At the Adjutor Healthcare Group, we can develop a global strategy which includes Australia, and meets your global development objectives.
We provide support from the initial stages of product development through to product registration/ lifecycle management for prescription and non-prescription medicines including biologicals. Our team of experts is highly responsive, agile, and adaptable. We prioritise flexibility, collaborative work, and reliability to ensure seamless navigation through the regulatory process and to maximise the success of our clients’ endeavours.
In Australia, the governing body for medicinal and pharmaceutical products is the Therapeutic Goods Administration (TGA).
Before a therapeutic good can be supplied to the Australian market, a company (referred to as the ‘sponsor’ or ‘applicant’) must obtain pre-market approval from the TGA. In most cases this involves entry of the product in the Australian Register of Therapeutic Goods (ARTG).
Through our extensive networks of Partners we can provide in-country caretaker, Marketing Authorisation Holder, Regulatory Agent and Sponsor Services for clinical trials, regulatory submissions and, in many cases, also for marketed products.
Ready to get started on your project? – Contact our team of TGA specialists today…
There are a number of pathways to medicine registration in Australia, some of which enable the fast tracking of product onto the Australian market. Adjutor’s TGA consultants have extensive experience with all these pathways, and we can develop a global strategy that maximises speed without jeopardising safety, efficacy, or quality.
Below you will find some general information on how to register a medicine in Australia.
Six Pathways for TGA Approval of Medicines in Australia –
- Standard Registration Pathway
- Priority Review Pathway
- Provisional Determination Pathway
- Comparable Overseas Regulators (COR) Report Based Pathway
- ACCESS Pathway
- Project Orbis
1. Standard Registration Pathway
The Standard Prescription Medicine Regulatory Pathway involves a comprehensive de novo evaluation of the medicine’s quality, safety, and efficacy based on manufacturing, nonclinical, and clinical data. The review process can take typically 255 working days, depending on the complexity of the submission.
2. Priority Review Pathway
The Priority Review Pathway is designed to expedite the registration process for medicines that address an unmet medical need or offer a significant therapeutic advantage. It involves a full review of the medicine’s quality, safety, and efficacy, but with flexible administrative processes that prioritise evaluation. Sponsors must submit and gain approval by the TGA for Priority Designation prior to submission via this pathway. Where approval for Priority Designation is granted by TGA, Sponsors have 6 months to submit the full registration application, or the designation will lapse. The priority review pathway can achieve evaluation in just 150 working days.
3. Provisional Determination Pathway
The Provisional Determination Pathway is intended for medicines that show promise but have limited clinical data on hand at the time of submission. This route allows for provisional registration based on preliminary evidence of efficacy and safety, with a commitment to providing additional data within a specified timeframe (typically two years). Provisional registration is limited to a maximum of six years, during which the sponsor must submit a complete data set for a full evaluation and conversion to full registration. Dependant on whether the eligibility criteria is met, the provisional determination pathway will have your medicine evaluated in 255 working days and allows for those in need, access to the medicine whilst clinical data is generated.
4. Comparable Overseas Regulators (COR) Report Based Pathway
This pathway allows for accelerated medicine registration in Australia via a reliance pathway where overseas de novo evaluation forms the basis for TGA assessment. This pathway is further sub-categorised into COR-A and COR-B pathways.
- Under COR-A, the TGA will base their regulatory decision on the evaluation of the COR assessment reports and evaluation of the Australian label, Product Information (PI) and where required the Risk Management Plan (RMP) of medicine approved in the last 12months. COR-A involves a streamlined assessment based on the overseas approval. COR-A applications are evaluated within 120 working days.
- Under COR-B, TGA will base their regulatory decision on the evaluation of the COR assessment reports including the evaluation of the label, PI and RMP. However, with COR-B the COR reference approval can be more than 12 months old and therefore the TGA allows some scope for submission of post registration variations as part of the COR-B application. Additional data for consideration under the COR-B process includes, updated stability data, validation data for an additional manufacturing site(s) and updates to pivotal studies that support the proposed indication. COR-B applications are evaluated within 175 working days.
5. ACCESS Pathway
The ACCESS Registration Pathway allows for robust work sharing when the same dossier is in Australia, Canada, Singapore, Switzerland, and the United Kingdom. If the evaluation of the dossier is accepted via this pathway, the approval process is based on a work and information sharing reliance and applications can be evaluated within 255 working days.
6. Project Orbis
Project Orbis is a collaborative initiative aimed at accelerating the review process for oncology products across multiple international regulatory agencies. Led by the United States Food and Drug Administration (FDA), Project Orbis facilitates simultaneous review and approval of oncology drugs among participating regulatory agencies, streamlining the process and potentially making innovative treatments available to patients more quickly worldwide.
Project Orbis partners include the regulatory agencies of:
- Australia – Therapeutic Goods Administration
- Brazil – National Health Surveillance Agency (ANVISA)
- Canada – Health Canada
- Israel – Ministry of Health
- Singapore – Health Sciences Authority
- Switzerland – Swissmedic
- United Kingdom – Medicines and Healthcare products Regulatory Agency (MHRA)
Project Orbis Type A are applications that are concurrently evaluated with the FDA, enabling participating regulatory agencies to share and review documents, exchange detailed information regarding requests for information, and actively observe and engage in decision-making processes.
Project Orbis Type B are applications that are evaluated by the TGA, provided that no more than 30 days have passed since submission to the FDA. This process enables participating regulatory agencies to access FDA review reports, exchange requests for information, and engage in multi-country discussions by observing and participating as needed.
Project Orbis Type C are applications that undergo evaluation by the TGA following the FDA’s comprehensive assessment of a medicine. This pathway facilitates the sharing of completed review documents by the FDA with participating regulatory agencies, aiding them in their respective evaluations.
Navigating the complexities of product development, clinical development, regulatory services for product registration/ lifecycle management, quality/QMS, training and commercialisation requires a tailored approach that balances local requirements and global objectives.
At the Adjutor Healthcare Group, we recognise the importance of not just understanding these pathways, but also leveraging our expertise to assist you in developing and executing your global strategy. Whether you are seeking to register a new medicine in Australia or expand into international markets, our team is equipped to guide you through every step of the process.
By collaborating with us, you gain access to a wealth of knowledge and resources that can help streamline the registration process and ensure long-term success.
