Module 9 2021

23/03/2021

Change is INEVITABLE

Source: Alignment in post-approval changes (PAC) guidelines in emerging countries may increase timely access to vaccines: An illustrative assessment by manufacturers; Dellepiane et al. Vaccine : X 6 (2020) 100075

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Why worldwide regulatory environment is challenging for vaccines (and medicines in general)

Vaccines = complex products

Supply to Multiple Countries e.g. 170 countries

Production to distribution: 18-24 months

Multiple production and testing steps

Many changes require regulatory action

Multiple regulatory submissions required, per vaccine and per country

Complexity of supply

Can take 4+ years to complete global approvals

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