How we make regulatory decisions about medicines and medical devices

Role of MHRA and the scope of the document

Revised in September 2007

This document sets out:

• the main regulatory decisions that are made about medicines and medical devices,
• the principles that inform these decisions,
• the questions that are considered to ensure that the decisions are reasonable, and 
• who makes decisions about medicines and medical devices - which includes bodies other than MHRA.

The Medicines and Healthcare products Regulatory Agency (MHRA) has drafted this document after consultation with a range of external stakeholders, including healthcare professionals, bodies which represent patients and the public, and the pharmaceutical and medical devices industries. An earlier version was put on the MHRA website with an invitation for comments. We do not see this document as the last word on the subject and may undertake further consultation.

To summarise the role of the MHRA:

• We are the government agency responsible for ensuring that medicines and medical devices work, and are acceptably safe.
• No product is risk-free.  Underpinning all our work lie robust and fact-based judgements to ensure that the benefits to patients and the public justify the risks.
• We keep watch over medicines and devices, and we take any necessary action to protect the public promptly if there is a problem.
• We aim to make as much information as possible publicly available.
• We enable greater access to products, and the timely introduction of innovative treatments and technologies that benefit patients and the public.
• We encourage everyone - the public and healthcare professionals as well as the industry - to tell us about any problems with a medicine or medical device, so that we can investigate and take any necessary action.

The term “medicines” embraces both pharmaceutical and biological medicines, and vaccines.

The term “medical devices” includes medical equipment. Medical devices are all products, except medicines, used in healthcare for the diagnosis, prevention, monitoring or treatment of illness or disability. Examples include X-ray and other imaging equipment, pacemakers, artificial joints, anaesthetic equipment, pregnancy test kits, infusion equipment, beds, wheelchairs, condoms and surgical dressings.

This document refers to both kinds of products however they are available, whether by prescription or over the counter, or in use by healthcare professionals for the benefit of their patients.

It is important to note that these few pages do not attempt to provide a detailed explanation of MHRA’s legal framework and its regulatory processes.  Much more about these can be found elsewhere on this website. There are also some significant differences between the ways medicines and medical devices are regulated. While the document refers to some of them, its main purpose is to cover the issues common to both kinds of product.

 

| Next >