Module 9 2024

03/09/2024

Why do Variations Impact Supply?

Together, this means that vaccines require submission of many variations or supplements over many years + because they are combination products or use the same adjuvant, changes are often repeated across multiple product licences

Complex biological products

Can take 4+ years to

complete global approval of ONE change

Often in combination

Answer = RELIANCE?!

Very long life cycles

Which can risk supply disruption + slow/prevent implementation of innovative changes

Large volumes and long distribution needed for supply

The Organisation for Professionals in Regulatory Affairs

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Official Lot Release Testing

Company Lot Release

Same lot = multiple tests

+

Many countries now require lot release of vaccines

Official/National Vaccine Release Official/N tional

Official/National Vaccine Release

Vaccine Release Official/N tional

Vaccine Release Official/N tional

Mechanism varies (**) • lab testing vs. paper release • every lot vs. periodic testing

Vaccine Release Official/National

Vaccine Release Official/N tional

Vaccine Release Official/N tional Vaccine Release

Greater use of reliance and recognition mechanisms would be helpful to reduce repeat testing

The Organisation for Professionals in Regulatory Affairs

**Often requires batch summary information for each lot; transfer of laboratory assays; provision of biological standards/assay standards

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