The Medicines and Healthcare products Regulatory Agency (MHRA) is the UK government agency which is responsible for ensuring that medicine

Medicine

Medicine is the science and art of healing. It encompasses a variety of health care practices evolved to maintain and restore health by the prevention and treatment of illness....

s and medical device

Medical device

A medical device is a product which is used for medical purposes in patients, in diagnosis, therapy or surgery . Whereas medicinal products achieve their principal action by pharmacological, metabolic or immunological means. Medical devices act by other means like physical, mechanical, thermal,...

s work and are acceptably safe.

The agency was formed on 1 April 2003 with the merger of the Medicines Control Agency (MCA) and the Medical Devices Agency (MDA). It is an executive agency

Executive agency

An executive agency, also known as a next-step agency, is a part of a government department that is treated as managerially and budgetarily separate in order to carry out some part of the executive functions of the United Kingdom government, Scottish Government, Welsh Assembly or Northern Ireland...

 of the Department of Health.

Roles of the MHRA

1. Operate post-marketing surveillance
   Postmarketing surveillance
   Postmarketing surveillance is the practice of monitoring the safety of a pharmaceutical drug or device after it has been released on the market and is an important part of the science of pharmacovigilance...
   
    for report
   Report
   A report is a textual work made with the specific intention of relaying information or recounting certain events in a widely presentable form....
   
   ing, investigating and monitoring of adverse drug reactions to medicines and incidents with medical devices.
2. Assessment and authorisation of medicinal products for sale and supply in UK
   United Kingdom
   The United Kingdom of Great Britain and Northern IrelandIn the United Kingdom and Dependencies, other languages have been officially recognised as legitimate autochthonous languages under the European Charter for Regional or Minority Languages...
   
   .
3. Oversee the Notified Bodies that ensure medical device manufacturers comply with regulatory requirements before putting devices on the market.
4. Operate a quality surveillance system to sample and test medicines to address quality defects and to monitor the safety and quality of unlicensed products.
5. Investigate internet sales and potential counterfeiting of medicines, and prosecute where necessary.
6. Regulate clinical trials of medicines and medical devices.
7. Monitor and ensure compliance with statutory obligations relating to medicines and medical devices.
8. Promote safe use of medicines and device
   Medical device
   A medical device is a product which is used for medical purposes in patients, in diagnosis, therapy or surgery . Whereas medicinal products achieve their principal action by pharmacological, metabolic or immunological means. Medical devices act by other means like physical, mechanical, thermal,...
   
   s.
9. Manage the General Practice Research Database
   General Practice Research Database
   The General Practice Research Database is a large database of anonymised medical records from GP practices around the UK. The database is considered by many to be the 'gold standard' of longitudinal anonymised patient databases from primary care. It has been used in over 600 clinical reviews and...
   
    and the British Pharmacopoeia
   British Pharmacopoeia
   The British Pharmacopoeia is an annual published collection of quality standards for UK medicinal substances. It is used by individuals and organizations involved in pharmaceutical research, development, manufacture and testing....
   
   .

MHRA hosts and supports a number of expert advisory bodies, including the Commission on Human Medicine which replaced the Committee on the Safety of Medicines

Committee on the Safety of Medicines

The Committee on the Safety of Medicines was an independent advisory committee that for 40 years advised the UK Licensing Authority on the quality, efficacy and safety of medicines....

 in 2005, and the British Pharmacopoeia Commission.

As part of the European system of approval, MHRA or other national bodies can be the rapporteur or co-rapporteur for any given pharmaceutical application, taking on the bulk of the verification work on behalf of all members, while the documents are still sent to other members as and where requested.

See also

• European Medicines Agency
  European Medicines Agency
  The European Medicines Agency is a European agency for the evaluation of medicinal products. From 1995 to 2004, the European Medicines Agency was known as European Agency for the Evaluation of Medicinal Products.Roughly parallel to the U.S...
  
   (EMA)
• List of pharmacy organizations in the United Kingdom
• Regulation of therapeutic goods
  Regulation of therapeutic goods
  The regulation of therapeutic goods, that is drugs and therapeutic devices, varies by jurisdiction. In some countries, such as the United States, they are regulated at the national level by a single agency...
  
  
• Black triangle scheme
  Black triangle (pharmacology)
  A black triangle appearing after the trade name of a British medicine indicates that the medication is new to the market, or that an existing medicine is being used for a new reason or by a new route of administration....
  
  
• Yellow Card Scheme
  Yellow Card Scheme
  The Yellow Card Scheme is the UK system for collecting information on suspected Adverse Drug Reactions to medicines. The Scheme was founded in 1964 after the thalidomide disaster, and was developed by Dr Bill Inman....
  
  
• Food and Drug Administration
  Food and Drug Administration
  The Food and Drug Administration is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments...
  
   (FDA)

External links

• MHRA homepage
• Interview with Chief Executive (Prof. Kent Woods) about MHRA (Medicine Magazine
  Medicine Magazine
  Medicine Magazine is a UK consumer magazine focused on health and medical issues. It has a more serious medical and scientific editorial than women's magazines....
  
  )
• House of Commons Health Select Committee report of 2005 - criticism of the MHRA
• Which? Campaigns - healthcare - Which? campaigns focussing on the MHRA
• Ipsos MORI Research for MHRA: views of the public and healthcare professionals - factual