Spring Intro 2023

03/03/2023

More recent history….

• Medicinal regulation developed across Europe at the same time as the European Economic Community was being born

• The first European Directive on pharmaceuticals was issued on 26th January 1965 (65/65/EC)

• The primary purpose of all medicines regulation worldwide is:

THE SAFEGUARDING OF PUBLIC HEALTH

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How the regulations arose

• As with most laws, the rules that govern them are often written or tightened in response to one or more disasters e.g. • US – Elixir of Sulfanilamide (1930s) ● A solution formulated with diethylene glycol, tested for flavour appearance and fragrance only, without toxicology testing ~ 100 deaths

● Food and Drugs Act, (FDA) (1938) – Introduced pre-market drug review – Manufacturers needed to present evidence of the drug’s SAFETY • UK – Thalidomide (1960s) ● UK Committee on Safety of Drugs (1963) ● UK Medicines Act (1968) ● Product Licensing in the UK became mandatory from 1971

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