Safety, Quality, Efficacy: Regulating Medicines in the UK

SAFETY, QUALITY, EFFICACY: REGULATING MEDICINES IN THE UK
Appendix 1
Chronology of medicines control in
the UK
1864 First ever edition of the British Pharmacopœia is published.
1925 The Therapeutic Substances Act introduces a licensing system for biological products such as vaccines, insulin and
surgical sutures.
1948 Creation of the National Health Service.
The Committee on Classification of Proprietary Medicinal Products is set up to consider the practicality and
desirability of limiting or prohibiting the prescribing of certain medicines already on the market.
1963 The Committee on Safety of Drugs is set up in the wake of the thalidomide tragedy. Its membership includes
independent experts in the fields of medicine, pharmacy, toxicology, pharmacology and statistics. The
pharmaceutical industry agrees to submit data on products to the Committee and abide by its advice on safety.
1964 Introduction of the Yellow Card Scheme for spontaneous reporting of suspected adverse drug reactions.
1965 A European Economic Community Directive sets out the legal basis for control of medicines introduced in its
member states.
1968 The Medicines Act, which provides for a comprehensive system of licensing affecting manufacture, sale, supply and
importation of medicinal products into the UK, receives Royal Assent.
1971 Implementation of the Medicines Act provisions and creation of the Committee on Safety of Medicines.
1972 Medicines Division of the Department of Health is set up to control the licensing of medicines in the UK.
1973 UK joins the European Economic Community.
1989 Medicines Control Agency is established by the reorganisation of the Medicines Division.
1991 Medicines Control Agency becomes an Executive Agency of the Department of Health.
1993 Medicines Control Agency achieves Trading Fund status.
1995 Creation of the European Medicines Evaluation Agency and the setting up of the system of centralised and
decentralised application routes.
1995 UK legislation is brought into line with the European legislation relating to marketing authorisations, labelling and
leaflets, through the Marketing Authorisations Regulations.
June 2002
Merger of the Medicines Control Agency and the Medical Devices Agency is announced. The merger will take effect
from 1 April 2003.
appendix one
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