International Regulators Say Collaboration Is Key To Tackling Pharma Globalization Challenges
Regulators from Canada, the UK and Australia discuss their experiences of working together under both the ACCESS Consortium, an international regulatory worksharing coalition, and Project Orbis, a parallel review process designed to speed up access to oncology medicines.
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Sixteen cancer therapies have been granted marketing authorizations or label variations in the US this year via the Project Orbis scheme. However, the majority of these are still under review by Orbis partners, which have also been outpaced by the non-Orbis EU.
A work-sharing group made up of regulators in Australia, Canada, Singapore, Switzerland and the UK has been expanded to include advanced therapy medicinal products, which could lead to greater harmonization in the regulatory approaches taken by different agencies.
In the second of a two-part interview with the Pink Sheet, an expert from the Swiss drug regulator discusses the similarities and differences between the ACCESS Consortium and Project Orbis, while the Canadian regulator also offers its perspective.