“Medicines and Healthcare products Regulatory Agency:
An executive agency of the Department of Health
_
We enhance and safeguard the health of the public by 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.“
_
http://www.mhra.gov.uk/index.htm
_
_
“Who we are
_
The MHRA was set up in April 2003 from a merger of the Medicines Control Agency and the Medical Devices Agency. The MHRA is the government agency which is responsible for ensuring that medicines and medical devices work, and are acceptably safe.
_
The MHRA is an executive agency of the Department of Health.”
_
http://www.mhra.gov.uk/Aboutus/Whoweare/index.htm
_
_
“About us
_
About us section
- The Medicines and Healthcare products Regulatory Agency (MHRA) is the government agency which is 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 industry - to tell us about any problems with a medicine or medical device, so that we can investigate and take any necessary action.”
http://www.mhra.gov.uk/Aboutus/index.htm
_
_
”Our mission and values
_
The MHRA's mission and values.
_
Mission
_
The MHRA’s mission is to enhance and safeguard the health of the public by ensuring that medicines and medical devices work, and are acceptably safe.
_
Values
_
In pursuing our mission we will strive to act with:
- integrity;
- openness;
- courtesy;
- responsiveness;
- timeliness;
- professionalism;
- impartiality; and
- consistency.”
http://www.mhra.gov.uk/Aboutus/Whoweare/Ourmissionandvalues/index.htm
_
_
"Our aims and objectives
_
The MHRA's aims and objectives.
_
Aims
_
Our aims are:
- Protecting public health through regulation, with acceptable benefit-risk profiles for medicines and devices.
- Promoting public health by helping people who use these products to understand their risks and benefits.
- Improving public health by encouraging and facilitating developments in products that will benefit people.
Objectives
_
Our strategic objectives are to:
- safeguard public health through our primary role in ensuring that the products we regulate meet required standards, that they work and are acceptably safe;
- carry out our communication role through the provision of accurate, timely and authoritative information to healthcare professionals, patients and the public;
- support research, ensuring through the application of Better Regulation principles that regulation does not stifle innovation;
- influence the shape of the future regulatory framework through use of our effective European and International relationships;
- run an organisation with a skilled and equipped workforce that is fit for the future."
http://www.mhra.gov.uk/Aboutus/Whoweare/Ouraimsandobjectives/index.htm
_
_
"Our activities
_
The MHRA's activities.
_
Our main activities are:
- assessing the safety, quality and efficacy of medicines, and authorising their sale or supply in the UK for human use;
- overseeing the UK Notified Bodies that audit medical device manufacturers;
- operating post-marketing surveillance and other systems for reporting, investigating and monitoring adverse reactions to medicines and adverse incidents involving medical devices and taking any necessary action to safeguard public health, for example through safety warnings, removing or restricting the availability of products or improving designs;
- operating a proactive compliance programme for medical devices;
- operating a quality surveillance system to sample and test medicines and to address quality defects, monitoring the safety and quality of imported unlicensed medicines and investigating Internet sales and potential counterfeiting of medicines;
- regulating clinical trials of medicines and medical devices;
- monitoring and ensuring compliance with statutory obligations relating to medicines and medical devices through inspection, taking enforcement action where necessary;
- promoting good practice in the safe use of medicines and medical devices;
- managing the General Practice Research Database (GPRD) and the British Pharmacopoeia (BP) and contributing to the development of performance standards for medical devices;
- offering scientific, technical and regulatory advice on medicines and medical devices; and
- providing the public and professions with authoritative information to enable informed dialogue on treatment choices.
These activities are supported by our ten divisions who are also responsible for: information management; providing executive support services; human resources; and finance."
_
http://www.mhra.gov.uk/Aboutus/Whoweare/Ouractivities/index.htm
_
_
"What we regulate
_
The MHRA regulates a wide range of materials from medicines and medical devices to blood and therapeutic products/services that are derived from tissue engineering."
_
http://www.mhra.gov.uk/Aboutus/Whatweregulate/index.htm
_
_
"What we regulate: Medicines
_
Whether it’s a medicine you buy, or one prescribed for you as part of a course of treatment, it’s reassuring to know that all medicines available in the UK are subject to rigorous scrutiny by the MHRA before they can be used by patients. This ensures that medicines meet acceptable standards on safety, quality and efficacy.
_
But what is, and is not, a medicine?
_
The law defines a medicine as something used in disease, whether it is used to prevent, treat or diagnose it, in anaesthesia, investigating conditions or interfering with the normal operation of the body. It does not include such things as contact lens fluids, food supplements and cosmetics.
_
Many factors are considered in deciding whether a product is actually a medicine such as what it contains, what it’s advertised or used for, the way it will be used, any particular targeting of the marketing information and what the promotional literature says. Claims that a product “supports” health or a healthy lifestyle is not usually considered as medicinal.
_
Control of medicines starts as soon as they are first discovered and tested in healthy volunteers, all the way through to when a company wants to change the conditions its products are approved for, such as changing the colour of the tablet or what it is used for."
_
http://www.mhra.gov.uk/Aboutus/Whatweregulate/Medicines/index.htm
_
_
"How we regulate
_
How we regulate section.
_
The 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 & Medical Devices Regulation: What you need to know'
_
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 Devices"
_
http://www.mhra.gov.uk/Howweregulate/index.htm
_
_
"Our structure
_
The MHRA' s main activities (below) are supported by our ten Divisions who are also responsible for: information management; providing executive support services; human resources; and finance.
_
The MHRA's activities:
- assessing the safety, quality and efficacy of medicines, and authorising their sale or supply in the UK for human use;
- overseeing the UK Notified Bodies that audit medical device manufacturers;
- operating post-marketing surveillance and other systems for reporting, investigating and monitoring adverse reactions to medicines and adverse incidents involving medical devices and taking any necessary action to safeguard public health, for example through safety warnings, removing or restricting the availability of products or improving designs;
- operating a proactive compliance programme for medical devices;
- operating a quality surveillance system to sample and test medicines and to address quality defects, monitoring the safety and quality of imported unlicensed medicines and investigating Internet sales and potential counterfeiting of medicines;
- regulating clinical trials of medicines and medical devices;
- monitoring and ensuring compliance with statutory obligations relating to medicines and medical devices through inspection, taking enforcement action where necessary;
- promoting good practice in the safe use of medicines and medical devices;
- managing the General Practice Research Database (GPRD) and the British Pharmacopoeia (BP) and contributing to the development of performance standards for medical devices;
- offering scientific, technical and regulatory advice on medicines and medical devices; and
- providing the public and professions with authoritative information to enable informed dialogue on treatment choices.
Corporate governance
_
The following structures and processes are designed to ensure accountability and give the Agency a framework for risk management:
- The Agency Board is made up of a non-executive Chairman, six non-executive members and the Agency's Chief Executive Officer.
- The Agency's Chief Executive is responsible for service delivery and resources.
- The Executive Board, consisting of the Agency's directors, takes overall responsibility for day-to-day management, strategic decision-making, line management, and all financial, policy, operational and resource management issues.
- The Risk and Audit Committee provides independent feedback to the Chief Executive, who is also the Accounting Officer, and the Management Board on the effectiveness of our risk management processes. The Committee is supported by the Agency's Risk Management Team."
http://www.mhra.gov.uk/Aboutus/Ourstructure/index.htm
