Module 9 2021

Regulators

• United States

– 1919 National Institutes of Health – 1972 FDA Bureau of Biologics – 1987 FDA CBER – 2001 onwards CDER/CBER

• 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

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 • A global organisation supported by governments to provide minimum standards for the world – World Health Organisation – Little industry involvement (mostly philanthropic) – Many other functions

The Organisation for Professionals in Regulatory Affairs

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