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P105: Assessing the Use of Risk-Based Approaches in Four Major Agencies – What is their Impact on the Approval of New Medicines?

Poster Presenter

Juan Ramón Lara

Senior Research Analyst
Centre For Innovation In Regulatory Science
Mexico

Objectives

Analyse the use of risk-based approaches (unilateral reliance, collaboration, and work-sharing) for the approval of New Active Substances (NASs) by four major agencies (FDA, Health Canada, Swissmedic and TGA). Evaluate the efficiency and impact of those approaches on the availability of NASs.

Method

Information collected from the public domain on NAS approvals (submission date, approval date, risk-based route used) in four major agencies for 2018-2022 was analysed using descriptive statistics.

Results

Between 2018 and 2022, the proportion of NASs that went through at least one risk-based approach in the approval process was 9% for FDA, 20% for Health Canada, 23% for Swissmedic, and 30% for TGA. Although the percentages may be seen as low, these are higher than in the first half of the decade due to their unavailability. Unilateral reliance approaches: For Swissmedic and TGA, median approval times were shorter for unilaterally reliance-approved NASs compared to other NASs between 2019 and 2022. For Swissmedic, 16 NASs were approved through Art 13 TPA with a median approval time of 309 calendar days, while 4 NASs were approved through Art 14 TPA with a median approval time of 519. For TGA, three NASs were approved through COR-A with a median approval time of 214 calendar days, while 9 NASs were approved through COR-B with a median of 277. Collaborative approaches (Project Orbis): For FDA, Health Canada, Swissmedic, and TGA, median approval times and submission gaps (except for FDA) were shorter for Project Orbis-approved NASs than other NASs between 2019 and 2022. FDA approved 22 NASs through Project Orbis with a median approval time of 210 calendar days; Health Canada approved 20 NASs with a median of 267; TGA approved 17 NASs with a median of 346; Swissmedic approved 9 NASs with a median of 285. Health Canada showed a median submission gap of 173 calendar days, Swissmedic a median of 177, and TGA a median of 93. Work-sharing approaches (Access Consortium): For Health Canada, Swissmedic, and TGA, median approval times and submission gaps were shorter for Access Consortium-approved NASs than other NASs between 2018 and 2022. Health Canada approved 14 NASs through Access Consortium with a median approval time of 338 calendar days; Swissmedic approved 10 NASs with a median of 352; and TGA approved 16 NASs with a median of 322. Health Canada showed a median submission gap of 68 calendar days, Swissmedic a median of 63, and TGA a median of 108.

Conclusion

In recent years, there has been an increase in the availability and use of risk-based approaches for the approval of NASs in FDA, Health Canada, Swissmedic and TGA. These approaches, which can be unilateral reliance, collaborative, or work-sharing approaches, have proven their benefits in reducing median approval time. In addition, collaborative and work-sharing approaches have also shown benefits in reducing median submission gaps compared to non-risk-based-procedures. Further research should be done to identify possible ways to widen the use of risk-based approaches to further enable the timely availability of innovative therapies globally.