Collaboration among global regulators has streamlined the drug approval process, allowing patients to gain access to potentially life-saving drugs more quickly. The TGA’s flexible approach to approvals benefits the pharmaceutical industry and regulators alike. The Access Consortium promotes collaboration among regulators, and the Access Generic Medicine Work Sharing Initiative reduces the duplication of evaluation and speeds up the delivery timeline. The collaboration among regulatory authorities streamlines the drug approval process and benefits the pharmaceutical industry, regulators, and patients. Project Orbis saw 22 submissions approved in 2021-2022, twice the number approved the previous year. Work sharing among regulatory authorities allows for uniformity of global standards to improve the design of clinical trials and the drugs developed. Regulatory collaboration helps alleviate internal and external pressures. Global partnerships have become increasingly important in filling gaps in the evaluation process and navigating the legacy of COVID, including disruptions to the manufacturing and supply of medicines.
Global Regulators Join Forces to Improve Efficiency in Drug Approval Process
The COVID-19 pandemic has accelerated the trend towards greater collaboration between regulatory authorities across different regions of the world. The urgency of finding a vaccine to combat the deadly virus has driven global regulators to streamline drug approval processes and share expertise, resulting in timely access to life-saving drugs without compromising safety. This trend is expected to continue as regulatory authorities gain increasing confidence in collaborative initiatives.
Global regulators have long shared information, but the unnecessary duplication of evaluation processes led to delays in getting critical medicine to those who needed it most. The COVID-19 pandemic has broken down traditional barriers to approval, and regulatory authorities are now seeking greater efficiencies in the drug approval process.
Australia’s Therapeutic Goods Administration (TGA) has played a pivotal role in this trend. In 2018, the TGA recognized the need to reduce the duplication of evaluation processes and reviewed its assessment of dossiers for new registrations. Previously, a full assessment was conducted to determine the safety, efficacy, and quality of medicines before they were allowed to be released onto the market.
The TGA’s proactive approach to streamlining its evaluation process has paved the way for fast-tracked approvals of critical medicines in Australia. Traditionally, drugs sought approval in the United States and the European Union before being evaluated in Australia. This jurisdictional delay caused significant delays for Australians with life-threatening conditions such as cancer. By reducing the duplication of evaluation processes, the TGA has prevented unnecessary delays in getting critical medicine to those who need it most.
The COVID-19 pandemic has demonstrated that collaboration among regulatory authorities can result in timely access to life-saving drugs without compromising safety. Efforts to build greater harmonization between global regulators are expected to continue as regulatory authorities seek to build greater efficiencies into the drug approval process. With the momentum of this trend, it is likely that more collaborative initiatives will be developed to improve the drug approval process in the future.
Collaboration between Global Regulators Streamlines Drug Approvals
The COVID-19 pandemic has accelerated collaboration between global regulatory authorities to streamline drug approvals and share expertise. The pandemic drove the urgency for a vaccine to combat the virus, resulting in regulatory authorities breaking down traditional barriers to approval and collaborating to ensure timely access to life-saving drugs without compromising safety.
Australia’s Therapeutic Goods Administration (TGA) has been instrumental in streamlining the drug approval process by introducing more flexible pathways to approval for prescription medicines. Under the standard pathway, it could take the regulator up to a year to review the evidence of a drug that had already been approved in the US or the EU. To ensure patients with serious conditions gain quicker access to potentially life-saving drugs, sponsors can apply to fast-track the process through the priority review pathway or the provisional approval pathway.
The priority review pathway allows the TGA to complete an evaluation up to three months earlier by adopting a more flexible approach. This includes asking sponsors 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, sponsors can apply to the TGA to approve medicine for a serious or life-threatening condition for a limited period, making a drug available up to two years earlier than normal.
The TGA’s flexible approach to approvals benefits the pharmaceutical industry and regulators alike. Sponsors can release medicines in different regions simultaneously, and regulators can leverage other health regulators’ evaluation. Most importantly, it benefits patients by providing quicker access to new medicines or new uses for established medicines.
The Access Consortium, established by the TGA, Health Canada, Health Sciences Authority of Singapore, Swissmedic, and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), promotes collaboration among regulators and better alignment of requirements for drug approvals. The coalition aims to maximize the use of new technologies, reduce duplication, and ensure timely access to consumers. Each authority retains its autonomy over the approvals process, but collaboration enables the parties to reduce the duplication of essential evaluation and, therefore, the delivery timeline.
The Access Generic Medicine Work Sharing Initiative, a collaboration of the Access Consortium, has approved four submissions in 2021-2022. The initiative reduces the duplication of evaluation and speeds up the delivery timeline. The collaboration between regulatory authorities streamlines the drug approval process and benefits the pharmaceutical industry, regulators, and patients.
Global Collaboration among Regulators Improves Access to New Cancer Treatments
The FDA Oncology Center of Excellence established Project Orbis in 2019 to improve access to new treatments for cancer patients. The Therapeutic Goods Administration (TGA) joined the FDA and Health Canada in the first collaborative review of two cancer products, enabling simultaneous decisions in all three countries. The TGA’s provisional approval pathway brought the drugs to market.
Project Orbis saw 22 submissions approved in 2021-2022, twice the number approved the previous year. Collaborative work sharing among regulatory authorities allows for uniformity of global standards to improve the design of clinical trials and the drugs developed.
Collaboration among regulatory authorities also helps alleviate internal and external pressures. For example, 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. Global partnerships have become increasingly important in filling gaps in the evaluation process and navigating the legacy of COVID, including disruptions to the manufacturing and supply of medicines.
The changing pharmaceutical landscape, including the type of products and supporting technology, demands that regulatory scientists and evaluators upskill to ensure the continued efficacy, quality, and safety of approved medicines. Global collaboration and leveraging the expertise of others are among the best ways to achieve this.
The pharma industry’s response to the pandemic has created a blueprint for the future where collaboration is the norm. Regulatory collaboration has improved access to new cancer treatments, streamlined the drug approval process, and benefited the pharmaceutical industry, regulators, and patients.
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