Proposal to abolish CSM and create new version
Functions of the new CSM
The new commission will take on the functions currently performed
by the Medicines Commission (MC) and the Committee on Safety of
Medicines (CSM) in relation to medicines for human use.
· Advising on policy matters relating to medicines regulation
(MC)
· Advising on the safety, quality and efficacy of medicinal products
(CSM)
· Promoting the collection and investigation of adverse drug reaction
data (CSM)
· Advising on committees established under section 4 of the Medicines
Act 1968 (MC) |
Public consultation has started on an MHRA proposal to abolish the Committee on Safety of Medicines. The proposal is part of a wider review of all advisory committees established under the Medicines Act 1968.
The principal proposal is to replace both the Medicines Commission and
the Committee on Safety of Medicines with a new Commission on the Safety
of Medicines. The new commission will take on the amalgamated responsibilities
of its predecessors. Appointments to the new commission will be subject
to a full public appointments exercise with no presumption that existing
members will be re-appointed. The aim will be to have the new commission
up and running in January 2005.
The commission is to be supported by a number of expert groups, to be
called therapeutic advisory groups (TAGs). TAGs will have no decision-making
powers and some of them will be rebadged existing CSM subcommittees.
Two of the current Medicines Act committees — the Veterinary Products
Committee and the British Pharmacopoeia Commission — are to be
retained. A third — the Advisory Board on the Registration of Homoeopathic
Products will be abolished and replaced by a TAG.
The new commission is expected to have 10–12 core members appointed
by Ministers. Members will be expected to have high scientific expertise,
to be competent in critical appraisal and able to contribute beyond their
own individual specialties. The majority of TAGs will exist as standing
committees with permanent chairmen and one or two permanent experts.
Other experts would be invited for specific topics.
The change is being proposed because European medicines legislation has
changed the work of the MHRA in recent years and this has had an impact
on the type and volume of work being brought before the Medicines Act
advisory committees. Also, the work of the MC has steadily diminished
over recent years because of changes in licensing arrangements and other
procedural changes within the MHRA, such as those related to the reclassification
of medicines. |
The
Pharmaceutical Journal