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Changes to Medicines Regulation in the UK

Posted by ed_uk on April 5, 2005, at 9:09:02

Changes are being made at the MHRA (our 'FDA' if you like)...............

The MHRA 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/Paxil 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 'Commission for Human Medicines' has been formed in order to replace the 'Committee on Safety of Medicines'.

Regulations were today introduced to abolish the Medicines Commission and the
Committee on Safety of Medicines. The amendments to the Medicines Act 1968
have replaced these with the establishment of a new Commission – The Commission
for Human Medicines.
There is now a requirement for a greater degree of expert scientific judgement at the
earlier stages of specific product developments and following on from extensive
consultation a need for a more transparent structure. The amendments therefore
have removed the entitlement provision of industry to be represented on the
Commission, have updated the handling of, conflicts of interest and are to increase
lay membership on the Committee.
Some specialised Committees will remain and at least 10 new Expert Advisory
Groups will be set up to advise them on specific and technical issues. These ‘section
4’ Committees will be able to advise Ministers direct. Within the revised structure
separate arrangements will be made to ensure the views of industry are heard across
a wide range of topics.
It is anticipated that there will be a maximum of 18 members plus a Chairperson
recruited to this Commission with adverts for positions appearing in early April 2005,
the NHS Appointments Commission will be managing this process.


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poster:ed_uk thread:480104
URL: http://www.dr-bob.org/babble/20050404/msgs/480104.html