Official regulation of medicines

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Official regulation of medicines

Aim is to provide effective and safe medicines.

Becoming increasingly complex.

Basic requirement is that no medicine may be prescribed, sold or supplied without prior licensing or registration by the government

Tension between ensuring the safety of a drug vs the need to bring a potentially useful drug to the market quickly

NSA-Food, Drug & Cosmetic Act- established Federal Drug Administration (FDA) to enforce safety requirements

Regulation of Medicines in Different Countries:

USACanadaUnited KingdomAustraliaNew Zealand
South AfricaSingapore

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