Pharmacy should be involved in European child research plans
Specialist paediatric pharmacists should be involved in the operation of European plans to make more licensed medicines available for the treatment of children, the Royal Pharmaceutical Society says.
Responding to a Medicines and Healthcare products Regulatory Agency consultation
on a proposed
European Regulation on paediatric medicines (PJ, 4 June,
p672), the Society says that a planned paediatric committee at the European
Medicines Agency should include pharmacy expertise. The committee would
be responsible for approving paediatric research while new medicines
are under development and for running a system of waivers and deferrals
where such research is to be delayed.
In this regard, the Society adds that
the Neonatal and Paediatric Pharmacists
Group should be included in a
list of paediatric learned societies that would be consulted about membership
of the paediatric committee.
The Society’s response says that it supports the planned system
of paediatric investigation plans and the extension of patents for products
where child research is carried out. But it adds that patent extensions
should be granted as a result of studies that provide information that
is relevant for the treatment of children.
The Society also supports the use of a code or mark so that medicines
that have been approved for paediatric use are clearly identifiable.
But it opposes the proposed use of the letter P because this is already
used in the UK to identify medicines that are restricted to sale or supply
from pharmacies. |
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Pharmaceutical Journal
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