re ........what is the M.H.R.A

December 11, 2004

The M.H.R.A ...........is Medicines and Healthcare products

Regulatory Agency and as such is the UK's equivalent of your F.D.A.

to research more on the M.H.R.A visit

http://www.mhra.gov.uk/aboutmhra/aboutmhra.htm

About the MHRA

Introduction

Welcome to the 'About the MHRA' section of our site. This section

includes the key aims, objectives, activities and corporate

governance of the MHRA as well as details of our Ministers and our

locations. Also, if a career with the MHRA appeals to you, have a

look at our 'Job vacancies' section.

The MHRA

From 1 April 2003, the Medicines and Healthcare products Regulatory

Agency (MHRA) replaced the Medical Devices Agency (MDA) and the

Medicines Control Agency (MCA). The MHRA is an executive agency of

the Department of Health with trading fund status.

Our aims

Our aims are to safeguard public health by:

ensuring that medicines for human use, sold or supplied in the UK,

are of an acceptable standard of safety, quality and efficacy

ensuring that medical devices meet appropriate standards of safety,

quality and performance

promoting the safe use of medicines and devices.

Our objectives

Our key objectives are to:

make an effective contribution to public health

provide authoritative and accessible information

influence international regulation

support industry and scientific innovation

operate a successful and a fully integrated business

minimise the cost of regulation.

Our activities

Our main activities are:

assessing the safety, quality and efficacy and authorising medicines

sold or supplied in the UK for human use

overseeing the Notified Bodies that audit 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 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 devices through inspection, taking

enforcement action where necessary

promoting good practice in the safe use of medicines and devices

managing the General Practice Research Database (GPRD), the British

Pharmacopoeia (BP) and the Device Evaluation Service, and

contributing to the development of performance standards for medical

devices.

These activities are supported by our ten divisions who are also

responsible for: information management; providing executive support

services; human resources; and finance.

Corporate governance

These 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.

Agency Board

The Agency Board is primarily responsible for advising on the

strategic development of the Agency and ensuring that targets set

out in our Business Plan (240KB) and endorsed by Ministers are met.

It does this by discussing and commenting on:

draft strategy papers

reports commissioned by the Agency

planning documents - drafts of the Business and Corporate Plan

budget updates

reports on Agency operations.

It does not have executive powers or line management responsibility

for any Agency staff but the public and private sector experience of

the non-executive Board members is used to the benefit of the Agency

in an advisory capacity.

Membership

The Agency Board is chaired by the MHRA Chairman, and consists of

six non-executive directors and the Chief Executive Officer:

Professor Sir Alasdair Breckenridge, MHRA Chairman

Professor Kent Woods, MHRA Chief Executive

Professor Angus Mackay

Mr Fox

Miss Dolan

Mr Kernahan

Mr Garry Watts

Ms Arnold

MHRA Executive Board

The Executive Board's primary responsibilities are to ensure that:

the strategic direction set by the Agency Board is implemented and

reflected in the day- to-day operations of the Agency

the Agency's targets are met

principles of good governance are followed

the Agency is well managed financially

appropriate human resources (HR) policies are followed

the culture of the Agency enables it to meet its aims and

objectives.

The Executive Board meets these responsibilities by:

developing strategy papers to discuss with the Agency Board

agreeing ways of delivering the strategic direction set by the

Agency Board

effectively managing the Agency on a day-to-day basis

reporting to the Agency Board on the operations of the Agency.

Membership

The Executive Board is chaired by the Chief Executive and consists

of the executive directors of the Agency from the operating

divisions in medicines and devices and also from the policy and

support divisions:

Professor Kent Woods, Chief Executive

Dr Ian Hudson, Licensing

Dr June Raine, Post Licensing

Mr (Acting Director), Inspection and Enforcement

Mr Roy Alder, Executive Support

Mr Graham Savage, Finance

Miss Doreen Hepburn, Information Management

Dr Louise Wood, GPRD

Mr Clive Bray, Device Technology Evaluation and Safety

Dr ne Ludgate, Devices Clinical

Mr Geoff LeFevre, Human Resources

For further information on this section of the site please

contact our Information Centre, 10-2, MHRA, Market Towers, 1 Nine

Elms Lane, London SW8 5NQ, telephone 020-7084 2000, fax 020-7084

2353 or e-mail info@...

Page last modified: 22 September 2004

> WHAT DOES MHRA STAND FOR?

> *******************************

>

> MIND: the UK's leading mental health charity is headed by Chief

> Executive Brook who resigned in protest from the MHRA.

>

> A courageous action bringing to boiling point our long campaign to

> expose dangerous ssri's/snri's .

>

> http://www.network54.com/Forum/message?

> forumid=281849 & messageid=1102807151

>

> Immediate release - Friday 10th October 2003

>

> Mind seeks feedback on coming off pyschiatric drugs for

> groundbreaking new survey

>

> Mind today launches a new project `Coping with coming off',

> which

> will explore people's experience of withdrawing from psychiatric

> drugs. Many people who have been prescribed psychiatric drugs such

> as antidepressants, sleeping pills or major tranquillisers, but no

> longer need or want them can find it very difficult to come off.

The

> charity is looking for people who have come off or tried to come

off

> psychiatric drugs who are willing to take part in the study.

>

> The project will aim to improve understanding of what makes

> withdrawal more or less likely to be successful, so that Mind can

> provide information to individuals who are stopping taking a drug

> and to the health care practitioners supporting them. It also aims

> to inform and influence the provision of support services and the

> training of health professionals.

>

> Several psychiatric drugs have come under the media spotlight

> recently. Earlier this year two SSRI antidepressants were withdrawn

> for use on under-18s because of concerns about side effects and

> withdrawal (*1). A Panorama/Mind survey of people who emailed the

> BBC programme after a broadcast about the antidepressant Seroxat,

> found that 91 per cent of people who responded and who had taken

> Seroxat had tried to stop taking the drug, mostly because of

> unwanted side effects and 83 per cent of those people experienced

> withdrawal problems (*2).

>

> Speaking today, project coordinator Alison Cobb said: " Withdrawal

> effects from psychiatric drugs can be very distressing and

> frightening. People should not be left to handle it on their own,

> but get the information and support they need. Mind hopes that this

> survey will better our understanding of the process of withdrawing

> and improve the process for everyone involved. "

>

> If you have personal experience of coming off or trying to come off

> any psychiatric drugs, and you would like to be interviewed for

this

> new project please print a questionnaire from Mind's web site at

> www.mind.org.uk or contact the PPU Administrator at Mind, 15-19

> Broadway, London E15 4BQ for copies.

>

> *** ENDS ***

>

> NOTES TO EDITORS:

>

> (*1) The MHRA has banned the prescription of SSRI anti-depressants

> Seroxat and Efexor to children and adolescents under 18 with

> depression

>

> (*2) Panorama/Mind Yellow Card Survey 2003.

>

> (*3) Psychiatric drugs include antidepressants, minor

tranquillisers

> and sleeping pills, major tranquillisers such as Largactil,

Depixol,

> Clozaril or Risperidone, and mood stabilisers such as lithium or

> carbamazepine.

>

http://www.mind.org.uk/News+policy+and+campaigns/Press/New+Mind+proje

> ct+seeks+feedback+on+coming+off+psychiatric+drugs.htm>

> 'Coping with coming off' MIND ...seeks

feedback on

> withdrawing from psych drugs.

December 11, 2004