Spring Intro 2023

30/03/2023

How ? Beyond EU: AUS, CAN, CH

Significant pharmaceutical market size in AUS, CAN, CH (and more) often with pressure to file as quickly as possible.

• National filing routes can be used leveraging amended US or EU dossiers • Relatively new shared/ reference filing routes available: • ACCESS Consortium (previously called ACSS) • ORBIS • OPEN (Opening our Procedures at EMA to Non-EU authorities) – EMA pilot to support the accelerated development and assessment of medicines for COVID-19 – Regulators from Australia, Canada, Japan, Switzerland and WHO are participating under the terms of existing confidentiality arrangements, with additional observers selected by WHO. – Following this one-year experience review the main objective during 2022 was to engage with all stakeholders to better define the terms of reference and agree on a stepwise approach to expand the use of OPEN in line with all the stakeholders’ goals and objectives.

The Organisation for Professionals in Regulatory Affairs

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ACCESS Consortium

• Countries: Australia, Canada, Singapore, Switzerland, GB recently joined • The consortium is a medium-sized coalition of regulatory authorities that work together to promote greater regulatory collaboration and alignment of regulatory requirements. • Company can request an MAA is reviewed across the consortium (some or all countries) • Requirements: Required 3-6 months heads up, global dossier • Timelines: Potentially faster than National review and approval • Process: ‘Workshare’

The Organisation for Professionals in Regulatory Affairs

Access Consortium Work-Sharing Initiative: An Industry Perspective (diaglobal.org)

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