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Regulatory Information

A key objective of the British Society for Nanomedicine is to facilitate the dissemination of pertinent data and information to those that need it. Since assessment schemes for the agencies that regulate the use of and exposure to nanoparticles are still evolving the Society aims to inform the ongoing nano debate. A list of agencies involved in the regulation of nanotechnologies, along with a brief description is given below.

The Medicines and Healthcare products Regulatory Agency (MHRA)

The Medicines and Healthcare products Regulatory Agency (MHRA) is the UK government agency which is responsible for ensuring that medicines and medical devices work, and are acceptably safe. The MHRA is an executive agency of the Department of Health. More information can be found at the MHRA website:  http://www.mhra.gov.uk

The European Medicines Agency (EMA)

The European Medicines Agency is a decentralised agency of the European Union, located in London. The Agency is responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in the European Union. More information can be found at the EMA web site: http://www.ema.europa.eu

The U.S. Food and Drugs Administration (FDA)

The U.S. Food and Drug Administration (FDA) regulates a wide range of products, including foods, cosmetics, drugs, devices, veterinary products, and tobacco products some of which may utilize nanotechnology or contain nanomaterials. Nanotechnology allows scientists to create, explore, and manipulate materials measured in nanometers (billionths of a meter). Such materials can have chemical, physical, and biological properties that differ from those of their larger counterparts. More information can be found at the FDA web site: http://www.fda.gov/ScienceResearch/SpecialTopics/Nanotechnology/default

The Health and Safety Executive (HSE)

The UK Health and Safety Executive (HSE) is the independent watchdog for work-related health, safety and illness. It is an independent regulator and acts in the public interest to reduce work-related death and serious injury across Britain’s workplaces.  More information can be found at the HSE web site: http://www.hse.gov.uk/

The Health Protection Agency (HPA)

The Health Protection Agency's (HPA) role is to provide an integrated approach to protecting UK public health through the provision of support and advice to the NHS, local authorities, emergency services, other arms length bodies, the Department of Health and the Devolved Administrations. The National Institute of Biological Standards and Control (NIBSC) merged in to the HPA on 1 April 2009. NIBSC is a world leader in the standardisation and control of biological medicines such as vaccines and products made from blood and tissues. More information can be found at the HPA web site: http://www.hpa.org.uk/