The historical development of medicines regulations
Attempts to regulate the quality of medicines in Britain date back to the Middle Ages, through the offices of the medieval Gild of Pepperers and, at a later date, such bodies as the Royal College of Physicians of London and the Society of Apothecaries.
The first British Pharmacopoeia of 1864 contained herbal remedies in which impurities and adulteration were common problems. As potent plant derivatives and new synthesized drugs appeared during the nineteenth century the control of drug purity and quality gained in importance.
The modern concepts of the control of drug safety in Britain originated in the Therapeutic Substances Act of 1925. Unfortunately, recommendations of a Select Committee on patent medicines in 1914 were never implemented due to the outbreak of World War I.
The Committee on Safety of Drugs, established on a voluntary basis in 1963, was not directly concerned with drug efficacy. It was only 17 years ago that an integrated regulatory system concerned with the safety, efficacy and quality of medicinal products was introduced in Britain through the implementation in 1971 of the Medicines Act of 1968.
The relatively limited experience, in historical terms, of comprehensive regulation at a national level suggests that caution and prudence should be exercised as future regulation within the EEC is discussed. The present institutions of drug regulation should be made more efficient before major changes evolve from them.
KeywordsMedicinal Product Medicine Regulation Drug Regulation European Economic Community Title Page
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