Module 9 2024

03/09/2024

And what about the Impact of Covid on vaccine regulatory systems…

New Normal?

Efficiency Gain

Old Normal

Pandemic

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Are we living in the New Normal?

Development

New Normal?

Greater consultation between regulator and industry

Efficiency Gain

Clinical development flexibilities to allow parallel development

Old Normal

Pandemic

Registration Procedures

Labelling

Single language labels + use of QR codes/e-labels

Pandemic response guidance/laws/regulations

Expedited procedures for product approvals

Remove expiry date – link though QR code

Reliance Mechanisms (use of reference agency)

Post-Approval Changes

Supply/Manufacturing

Accelerated, reliance-type approaches

Remote GMP inspections reliance on country of manufacture

Use of a risk-based analytical comparability assessment (and use of protocols)

Multi-sourcing and risk-based validations approaches

Reliance + mutual recognition for local batch release

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