Healthy Skepticism Library item: 1094

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Publication type: news release

Response to Health Select Committee report
MHRA 2005 Apr 4

Full text:

PRESS RELEASE
Date: 4th April 2005
Time: 1800
Subject: Response to Health Select Committee report
Contact: Press Office 020 7084 3535 or press.office@mhra.gsi.gov.uk

Health Select Committee Report

The MHRA is widely recognised as being amongst the most effective and progressive regulators of medicines and medical devices worldwide. Since the creation of the MHRA in April 2003, we have laid down strong foundations upon which we are building upon.

The MHRA takes its role very seriously and has made a number of improvements including

• Acting in patients interest, by being instrumental in becoming the first Member State within the EU to take action on the use of SSRIs in children (in June 2003) and publishing the Expert Working Group’s report on SSRIs in December 2004, the most comprehensive review of this product undertaken by any regulator
• Increasing the involvement of patients in the regulatory process by – the greater involvement of patient and lay members on our advisory committees, patient reporting of adverse drug reaction data and user testing of patient information leaflets
• Introduction of greater transparency into the operations of the Agency – including the publication of data to supplement regulatory decisions (e.g.
  in the case of Seroxat and HRT) and encouraging the use of data on adverse drug reaction (ADR’s) in medical research and the publication of all ADR’s on the MHRA website.
• The introduction of strict new measures on the marketing and advertising of medicines. The key principle behind the guidelines is that they aim to protect the public, by preventing people from being misled by poor advertising. Within these measures is a ‘name & shame’ system which has been set up to deal with those who fail to meet the standards.

The MHRA recognises the need for further debate about these issues, and indeed we have already taken a number of steps to promote a wider understanding and discussion on these matters.

The MHRA will continue to work closely with our colleagues in the Department of Health to safeguard public health for all.