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Last Updated: Sunday, 3 October, 2004, 12:54 GMT 13:54 UK
Q&A: Medicines regulation

Click on the links below to find out more about the regulation of prescription drugs regulation in the UK.

What is the MHRA?
Why was it set up?
What is the CSM?
What is the Yellow Card scheme?
Why was it introduced?


Generic pills

What is the MHRA?

The Medicines and Healthcare products Regulatory Agency (MHRA) is the body which is responsible for, among other things, drug licensing and regulation in the UK.

It was formed in April 2003 as a merger of two different agencies - the Medicines Control Agency and the Medical Devices Agency.

The Medicines Control Agency was previously responsible for the licensing and safety of new drugs, while the Medical Devices Agency (MDA) worked to ensure that medical devices (any medical product other than medicines) met quality and safety standards.

The MHRA is "committed to safeguarding public health", making sure medicines, medical equipment and healthcare products meet safety and quality standards.

It regulates medical devices, licenses medicines, regulates clinical trials, issues safety warnings and provides advice and guidance on medicines and medical devices.

The medicines part of the MHRA is accountable to health and agriculture ministers in the UK.

Why was it set up?

Before the Medicines Act of 1968, there was no single piece of legislation which covered the regulation of prescribed drugs.

This act led to a series of changes which, in 1989, saw the creation of the Medicines Control Agency (which is now the MHRA)

The Medicines Act provided for a comprehensive system of licensing of manufacture, sale, supply and the importation of medicinal products into the UK.

What is the CSM?

The Committee for Safety in Medicines (CSM) is one of the independent advisory committees established under the Medicines Act of 1968.

It started life as the Committee on Safety of Drugs, which was set up after the thalidomide tragedy in the 1960s.

The CSM advises the UK Licensing Authority on the quality, efficacy and safety of medicines so that appropriate public health standards are met.

It is in this role that it runs the Yellow Card scheme.

What is the Yellow Card scheme?

The "yellow card" scheme, which allows medical professionals to report adverse reactions to drugs, has been in existence since 1964.

Reports are submitted to the CSM on a voluntary basis by doctors, dentists, pharmacists and coroners.

In the past 40 years, more than 400,000 reports of suspected reactions have been submitted.

Recently, the scheme has been extended to allow nurses, midwives and health visitors as well as radiographers and optometrists to report problems as well.

And there may be more changes on the way. The MHRA has accepted a recommendation in principle to allow members of the public to report adverse reactions to drugs.

Why was the yellow card system introduced?

The yellow card system was introduced after the thalidomide tragedy, which highlighted the need for keeping track of medicines which were already on the market.

It is seen as a vital way of gaining post-licensing feedback about drugs.

The thalidomide tragedy happened between 1959 and 1962, after thousands of women who had taken the drug to combat morning sickness during the early stages of pregnancy gave birth to deformed children.



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