regulatory agency

regulatory agency

Independent government commission charged by the legislature with setting and enforcing standards for specific industries in the private sector. The concept was invented by the U.S. government in 1887, and regulatory agencies exist almost exclusively in the U.S. The theory is that a commission of experts on the industry being regulated is better equipped to regulate it than the legislature or executive departments. Designed to operate with a minimum of executive or legislative supervision, agencies have executive, legislative, and judicial functions, and their regulations have the force of law. Important regulatory agencies include the Food and Drug Administration, OSHA, the Federal Communications Commission, and the Securities and Exchange Commission.

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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 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 of the Department of Health.

Roles of the MHRA

  1. Operate post-marketing surveillance for reporting, 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.
  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 devices.
  9. Manage the General Practice Research Database and the British Pharmacopoeia.

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 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.

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