Objectives and achievements of medicines regulation in the UK
Medicines regulation in the United Kingdom is concerned with protecting both the public health and the public purse.
In protecting the public health, the safety of marketed medicinal products during normal conditions of use is the predominant objective of drug regulation.
The Licensing Authority and the Committee on Safety of Medicines rely on three strategies — the control of quality, rigorous pre-marketing safety studies and post-marketing surveillance.
Since the early 1970s, through enactment of the Medicines Act and an emerging philosophy of rational prescribing by the medical profession, reasonable evidence of efficacy, as well as safety of a drug, has been required.
To protect the public purse, successive UK governments have tried to balance the dual objectives of cost-effective prescribing within the National Health Service and the promotion of a successful pharmaceutical industry, able to contribute to employment, exports and the economy as a whole.
KeywordsAdverse Drug Reaction National Health Service Drug Regulation Reasonable Evidence License Authority
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