Module 9 2021

23/03/2021

References for Vaccine Non-Clinical Annex

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Overview of Regulatory Procedures: Wide range of regulatory systems & agencies level of development Highly sophisticated NRAs; i.e. EU (EMA), USA (FDA), Australia (TGA), Canada (HC), Japan (PMDA). All involved at ICH level • High level of requirements, complexity, agency well resourced

Independent review

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• Good transparency with predictable timing Very limited agency organization in less developed countries • Approval based on reference country approval

• Focus on official documentation rather than a review of the scientific data

• Less transparent process – unpredictable review outcomes

• Large backlogs & variable review timings

• Extreme case of no regulatory authority (tend to be amongst least developed countries and rely upon UNICEF for vaccine supply)

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