CRED Getting the CMC Dossier Right 2024

28/08/2024

Brief History of Regulations...

• Historically, regulation has been introduced as reactions to events such as the European Thalidomide tragedy causing birth defects and the Elixir Sulphanilamide disaster which killed over 100 people in the US • 1906 - Public Pressure in the USA lead to the Pure Food and Drug act which prevents interstate trade in adulterated food, drugs and drinks • 1910 - Introduction of arsphenamine (anti syphilitic organic arsenical) let to the UK Therapeutic Substances Act • 1927 - Introduction of Elixir Sulfanilamide in the USA led to the USA Food, Drug and Cosmetic Act (1938)

The Organisation for Professionals in Regulatory Affairs

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Brief History of Regulations... (cont)

• 1957 - Introduction of Thalidomide in Led to a number of new Laws: • USA Kefauver-Harris Drug Amendments (1962) • UK Committee on Safety Drug (1963) • UK Medicines Act (1968) • Today Advancing scientific Knowledge is the key driver for legislation changes and increasing R&D costs

The Organisation for Professionals in Regulatory Affairs

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