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Medicines and Healthcare products Regulatory Agency

 

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

Medicine is the art and science of healing. It encompasses a range 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 an object which is useful for diagnostic or therapeutic purposes. Examples of medical devices include medical thermometers, blood glucose monitorings, and X-ray machines....
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 Executive....
 of the Department of Health.








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

Medicine is the art and science of healing. It encompasses a range 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 an object which is useful for diagnostic or therapeutic purposes. Examples of medical devices include medical thermometers, blood glucose monitorings, and X-ray machines....
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 Executive....
 of the Department of Health.

Roles of the MHRA


  1. Operate post-marketing surveillance
    Surveillance

    Surveillance is the monitoring of behavior. Systems surveillance is the process of monitoring the behavior of people, objects or processes within systems for conformity to expected or desired Norm in trusted systems for security or social control....
     for report
    Report

    In writing, a report is a document characterized by information or other content reflective of inquiry or investigation, which is tailored to the context of a given situation and audience....
    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 Ireland, commonly known as the United Kingdom , the UK or Britain,is a sovereign state located off the northwestern coast of continental Europe....
    .
  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 an object which is useful for diagnostic or therapeutic purposes. Examples of medical devices include medical thermometers, blood glucose monitorings, and X-ray machines....
    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....
     and the British Pharmacopoeia
    British Pharmacopoeia

    Published annually, the British Pharmacopoeia is a collection of quality standards for United Kingdom 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 United Kingdom Licensing Authority on the quality, efficacy and safety of Medication....
 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 medication. From 1995 to 2004, the European Medicines Agency was known as The European Agency for the Evaluation of Medicinal Products....
     (EMEA)
  • 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 Pharmacology 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

    This article is about Human Medicines. For Veterinary Medicines, see the Suspected Adverse Reaction Surveillance Scheme.The Yellow Card Scheme is the UK system for collecting information on suspected Adverse Drug Reactions to medicines....
  • Food and Drug Administration
    Food and Drug Administration

    The U.S. Food and Drug Administration is an Government agency of the United States Department of Health and Human Services and is responsible for regulating and supervising the safety of foods, dietary supplements, Medications, vaccines, Biopharmaceutical, blood transfusion, medical devices, Electromagnetic radiation-emitting devices, veteri...
     (FDA)


External links

  • (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....
    )
  • - criticism of the MHRA
  • - Which? campaigns focussing on the MHRA
  • - factual