How we regulate

The Medicines and Healthcare products Regulatory Agency (MHRA) regulates a wide range of materials from medicines and medical devices to blood and therapeutic products/services that are derived from tissue engineering. This section helps describe how the MHRA manages each of these products, including the use of nanotechnology in some of them

The main difference between how medicines and medical devices are regulated lies in how a product gets onto the market. All medicines are directly approved by the MHRA which issues a 'marketing  authorisation', or licence. Manufacturers and distributors are also licensed directly by MHRA. Medical devices are approved by private sector organisations called 'notified bodies'. Their approval is needed before a CE mark can be put on the device, though the manufacture of low risk devices is simply registered with the MHRA. The MHRA audits the performance of notified bodies. However:
 

  • when a product is on the market and in use, there are more similarities than differences in the ways medicines and devices are regulated
  • there are similar systems for receiving reports of problems with products and similar ways of issuing warnings if problems are confirmed after investigation
  • there are also similar systems for inspection of manufacture to ensure that companies are complying with regulations, and similar ways of enforcing the law if that proves necessary.

Further information on how we regulate medicines and medical devices is available in our publication:

Medicines and Medical Devices Regulation: What you need to knowPDF file (opens in new window) (894Kb)

How we make regulatory decisions about medicines and medical devices
The MHRA and other related organisations make a lot of regulatory decisions. After consulting with a range of stakeholders we have set out on five pages the main considerations that affect those decisions:

A download version of the document is also available:

Making Regulatory Decisions about Medicines and Medical DevicesPDF file (opens in new window) (46Kb)


Medicines

Different pills
This section has information for the pharmaceutical industry. It includes information about applying for a marketing authorisation, our medicines regulatory news section, information about herbal and homeopathic medicines and details of inspections.
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Advanced therapy medicinal products

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This section provides advice and guidance on the regulatory arrangements that apply to advanced therapy medicinal products (ATMPs) and answers to frequently asked questions.
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Blood

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This section provides an introduction to the Blood Regulations that became effective from 8 November 2005.

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How we develop policy

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Making and implementing policy is a key element of the Agency’s work. This page provides further information about how we develop our policy.
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Devices

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This section has information for device manufacturers and those interested in the regulation of medical devices. It includes our devices regulatory news section, details of the Medical Device Directive and information about Notified Bodies.

Nanotechnology

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Nanotechnology is enabling the creation of a whole range of materials which have novel properties. It is likely to have a wide impact on medical devices, leading to innovative devices. This section provides details of our involvement in the regulation of nanotechnology.

New Technologies Forum

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This section contains information about the Medicines New Technologies Forum and the Medical Device New Technology Forum.

Our international activities

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This section provides information about our international activities and includes our work in Europe, Mutual Recognition Agreements and the Global Harmonization Task Force.
Page last modified: 04 December 2013