Module 9 2024

03/09/2024

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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Procedures – not the same everywhere

EU & USA

Rest of the world

– No/limited harmonization, unclear legislation – Long review times – Unpredictable outcomes / poor transparency – Lack of resource/expertise within NRAs – Reliance upon “source country” approval, – Separate, sequential development needed

– Clear legislation, regulations, & guidance – Predictable timelines – Level playing field – High level of expertise available within Regulatory Authorities & Advisory Bodies

But …

But…

Rapidly evolving environment

No guaranteed outcome

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–

– Strong desire for education & development – Increasingly favored region in which to conduct clinical development – Developing local innovative industry, focusing particularly on biotech – More opportunity to shape environment – Growing patient/public demand for better medicine/vaccines

– Vaccination schedule is not harmonized across EU (responsibility at national level) – Pricing/reimbursement at national level (EU) – New regulations increase demands placed upon innovator, eg, – Risk Management Plan – Medicines for Children (eg. PIP in EU) – Require ‘heavy’ post approval commitments, e.g. large phase IV studies

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Diversity in capabilities

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