Regulators across the globe are increasingly collaborating to build greater harmonization and share expertise for mutual benefit. This upward trend is being driven partly by the changes brought about by COVID-19, and as regulatory authorities gain increasing confidence in collaborative initiatives that are still in their infancy. The pandemic accelerated the level of collaboration among regulators and demonstrated what can be achieved when drug approval processes are streamlined to improve timely access for all without compromising safety. Collaboration also helps to navigate the legacy of COVID, including disruptions to manufacturing and supply of medicines. One of the best ways to upskill regulatory scientists and evaluators is to connect globally and leverage the expertise of others. Project Orbis, in particular, is a collaborative initiative that improves access to new cancer treatments for patients, with uniformity of global standards to improve the design of clinical trials and the drugs developed. The response to the pandemic from the pharma industry and its regulators has created a blueprint for the future whereby collaboration is the norm rather than the exception.
Global Regulators Collaborate to Streamline Drug Approval Process
Efforts to improve harmonization among global regulators have gained momentum, as regulatory authorities become more confident in collaborative initiatives that streamline drug approval processes for mutual benefit. This trend has been accelerated by the COVID-19 pandemic, which highlighted the importance of global collaboration to ensure timely access to life-saving drugs without compromising safety.
Traditionally, regulators in different regions shared information, but did not work together to streamline approval processes, resulting in unnecessary duplication and delays in accessing critical medicine. However, the urgent need to find a vaccine to combat the deadly virus worldwide drove regulators to break down traditional barriers to approval and work collaboratively across regions to develop effective vaccines.
Australia’s Therapeutic Goods Administration (TGA) had laid the groundwork for fast-tracked approvals in 2018 by reviewing the way it assessed dossiers for new registrations. Previously, a full assessment was performed to determine the safety, efficacy, and quality of medicines before allowing their release onto the market. However, to prevent unnecessary delays, the TGA recognized the need to reduce duplication of evaluation processes.
Traditionally, a new drug would have sought approval in the United States and the European Union before making its way to Australia for evaluation, causing delays that could prevent Australians with life-threatening conditions from accessing critical medicine in a timely manner.
The pandemic has shown what can be achieved when drug approval processes are streamlined through global collaboration. This growing trend is likely to continue as regulatory authorities seek greater efficiencies in the review process.
Collaborative Initiatives: Breaking Down Barriers
With COVID-19’s rapid and deadly spread, the pharmaceutical industry and its regulators worldwide were forced to break down traditional barriers to approval. Collaboration was essential to ensure all regions had access to vaccines at the same time.
The TGA’s review of the way it assessed dossiers for new registrations laid the groundwork for fast-tracked approvals in Australia. The regulator recognized the need to reduce duplication of evaluation processes to prevent unnecessary delays in getting medicine to those who need it most.
As regulatory authorities gain increasing confidence in collaborative initiatives, efforts to build greater harmonization between global regulators are likely to continue. Global collaboration will be essential to ensure timely access to life-saving drugs without compromising safety, and regulatory authorities will seek greater efficiencies in the review process.
TGA Approves Life-Saving Medicines through Flexible Approvals Pathways
The Therapeutic Goods Administration (TGA) of Australia has introduced more flexible pathways to approval for prescription medicines, ensuring patients with serious conditions do not wait unnecessarily for potentially life-saving drugs. Under the standard pathway, it could take up to a year for the TGA to review evidence of a drug that had already been approved in the US or the EU.
To fast-track the process and ensure timely access to new medicines, sponsors can apply through the priority review pathway or the provisional review pathway. Under the priority review pathway, the TGA can complete an evaluation up to three months earlier by adopting a more flexible approach, such as asking the sponsor questions as they arise rather than waiting to send a consolidated list of questions on completion of the assessment round.
Under the provisional approval pathway, a sponsor can apply to the TGA to approve medicine for a serious or life-threatening condition for a limited period while the pharmaceutical company completes final clinical trials. This pathway enables a drug to be made available up to two years earlier than normal.
COVID vaccines fell into this approval category because of the urgency of the situation. The TGA approved them on the basis of evident clinical data, with real-world data to validate the safety of the products to follow. This collaborative effort among regulators worldwide was a great example of global harmonization in drug development and getting the medicines reviewed and approved.
Flexible Approvals Pathways Benefit the Industry, Regulator, and Patients
This flexible approach to approvals benefits not only the pharmaceutical industry and the regulator but also patients who gain quicker access to new medicines or new uses for established medicines. Sponsors have an opportunity to release medicines in different regions at the same time, and the TGA can leverage other health regulators’ evaluations.
To maximize the use of new technologies and reduce duplication, the Access Consortium was established. It is composed of the TGA, Health Canada, Health Sciences Authority of Singapore, Swissmedic, and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). The consortium promotes collaboration among regulators and better alignment of requirements for drug approvals.
The coalition is committed to information and work sharing to reduce the duplication of essential evaluation and, therefore, the delivery timeline. While each authority retains its autonomy over the approvals process, such collaboration enables the parties to work together to reduce timelines. In 2021-2022, four submissions were approved through the Access Generic Medicine Work Sharing Initiative.
Through these flexible pathways and collaborations, the TGA is working to ensure that patients with serious conditions have access to life-saving medicines without unnecessary delay.
Project Orbis: Collaborative Global Review of Cancer Drugs
The Therapeutic Goods Administration (TGA) of Australia is a partner in Project Orbis, established in 2019 by the FDA Oncology Center of Excellence to improve access to new treatments for patients with cancer. The TGA joined the FDA and Health Canada in the first collaborative review of two products, allowing simultaneous decisions in all three countries with minor differences between their drug labels. The TGA used its provisional approval pathway to bring the drugs to market.
In 2021-2022, 22 submissions were approved through Project Orbis, double the number from the previous year. The collaboration acknowledges that international clinical trials play an increasingly important role in investigating the safety and efficacy of cancer drugs. Work sharing could have long-term benefits, with uniformity of global standards to improve the design of clinical trials and the drugs developed.
Benefits of Regulatory Collaboration
Collaboration among regulatory authorities alleviates internal and external pressures, such as when senior TGA reviewers retire or exit, and the regulator can draw on the expertise of partners to fill gaps in the evaluation process. Similarly, when Brexit forced the European Medicines Agency (EMA) to move from London to Amsterdam, the regulator lost many of its experts who did not want to relocate, making global partnerships all the more important.
Collaboration will also help regulators navigate the legacy of COVID, including disruptions to manufacturing and supply of medicines. The TGA has been working closely with its global counterparts to prevent or at least limit shortages.
Upskilling Regulatory Scientists and Evaluators
The pharma landscape is changing, and the medicines proposed for registration are getting more complex. With these changes comes a greater demand for regulatory scientists and evaluators who need to be upskilled to ensure the continued efficacy, quality, and safety of approved medicines. One of the best ways to do this is to connect globally and leverage the expertise of others.
Collaborative Blueprint for the Future
The response to the pandemic from the pharma industry and its regulators has created a blueprint for the future, where collaboration is the norm rather than the exception. Regulatory collaboration enables global harmonization in drug development and ensures that patients have timely access to life-saving medicines without unnecessary delay.
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