Less than a third of licence applications given CSM approval on first consideration
Less than a third of applications for a UK medicines marketing authorisation are given first-time approval from the Committee
on Safety of Medicines.
The CSM’s annual report for 2003 shows that the committee gave
first consideration
to a total of 74 applications for marketing
authorisations during the year, but granted only 21 of them.
The CSM’s report is one of seven annual reports published this
week by the various advisory committees established under the Medicines
Act 1968.
The report
from the Medicines Commission shows that the commission was
not entirely happy with a proposal during 2003 that advertising restrictions
should be lifted from over-the-counter medicines intended to treat 13
disease areas. The proposal has since been approved (PJ, 12 June, p730).
Although the report records that the commission was generally content
with the proposal, it had concerns over a lack of professional advice
for OTC products and possible drug interactions as a result of pharmacists
or GPs not knowing what medicines patients might be taking. The commission
took the view that the proposal was acceptable given the current situation,
but that
future OTC medicines in the 13 disease areas might not be suitable for
public advertising and that, if necessary, individual medicines
licences could include specific restrictions on advertising. |
The
Pharmaceutical Journal
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