An introduction to UK medicines regulation.
Although some form of medicine regulation has existed in the United Kingdom since the time of King Henry VIII, it was not until 1971 that a comprehensive regulatory system was introduced.
The new Medicines Act brought most previous legislation on medicines together and also introduced a number of other legal provisions for the control of medicines. It was an enabling Act providing for a system of licensing affecting manufacture, sale, supply and importation of medicinal products into the UK. It became unlawful to engage in these activities except in accordance with appropriate licenses, certificates or exemptions.
The UK was not the only country to control medicines in this fashion. Indeed, medicines control was an early area of activity of the European Economic Community (EEC). The first and basic EEC Directive to control medicines was introduced in 1965 (Directive 65/65/EEC). Requirements for the control of medicinal products by the Medicines Act matched those of existing European Directives and in some instances went beyond them (for example for clinical trials).
During the ensuing years the UK contributed, together with other Member States, to the development and updating of the EEC Directives in this area. European Community (EC) legislation now takes precedence over the Medicines Act, its Instruments and Orders, which are amended from time to time to align with new EC requirements.
The current relevant legislation is given in Directive 2001/83/EC relating to medicinal products for human use, amended by Directives 2002/98/EC, 2003/63/EC, 2004/24/EC and 2004/27/EC.
Safety, quality and efficacy are the only criteria on which legislation to control human medicines is founded. It is the responsibility of the MHRA and the expert advisory bodies set up by the Medicines Act to ensure that the sometimes difficult balance between safety and effectiveness is achieved. MHRA experts assess all applications for new medicines to ensure they meet the required standards. This is followed up by a system of inspection and testing which continues throughout the lifetime of the medicine. Safety monitoring is also continuous and the MHRA also ensures that doctors and patients receive up-to-date and accurate information about their medicines. This is achieved by ensuring that product labels, leaflets, prescribing information and advertising meets the required standards laid down by the Regulations.
Further information on how we regulate medicines in our publication:
› 'Medicines & Medical Devices Regulation: What you need to know' (894Kb)