Module 9 2024

03/09/2024

Regulators

United States •

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1930 National Institute of Health 1972 FDA Bureau of Biologics

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1987 FDA CBER

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• 2001 onwards CDER/CBER – CDER gained mAbs, proteins for therapeutic use, cytokines, enzymes etc, • CBER, Cellular products, gene therapy products, vaccines, plasma derived products, blood and blood components, human cells, tissues and cellular and tissue based products and others. • United Kingdom • 1925 Therapeutic Substances Act – State testing laboratories – Licensing of premises • 1968 Medicines Act (Medicines Control Agency) • 1975 Biological Standards Act (NIBSC) – Substances whose quality or potency cannot be adequately tested by chemical and physical means • 2003 Medicines and Healthcare products Regulatory Agency • 2013 MHRA and NIBSC merge

European Union • 1995 European Medicines Evaluation Agency • 2004 European Medicines Agency

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The Organisation for Professionals in Regulatory Affairs

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Harmonisers

Two principle harmonisers

• A coalition of regulators and manufacturers to satisfy each others’ needs and ends

• International Council on Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (1990)

• Tripartite agreements representing consensus between 3 regions

• US, EU and Japan (+ observers)

• Each contribute authority and industry representatives

Dedicated function

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• A global organisation supported by governments to provide minimum standards for the world

World Health Organisation

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• Little industry involvement (mostly philanthropic)

Many other functions

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The Organisation for Professionals in Regulatory Affairs

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