THE European Medicines Agency
has launched a public consultation
aimed at improving the rate of
clinical studies involving children
and herbal medicines.
“Herbal medicines are widely
used throughout the European
Union, often in children,” a
statement from the EMA said.
“Despite this, little clinical
information is available to allow
the evaluation of their indications,
dose, length of treatment and
safety when used in children,” the
The consultation follows the
launch of a draft reflection paper
‘on the necessity of initiatives to
stimulate the conduct of clinical
studies with herbal medicinal
products in the paediatric population’.
Initiatives proposed in the paper
include a focus on the identification
of herbal substances and
preparations expected to have a
therapeutic benefit, selected on the
basis of criteria identified by the
EMA’s Committee on Herbal
Medicinal Products and the
The paper also urges a focus on
guidelines and recommendations
for developing paediatric studies
for herbal medicines; as well as the
promotion of funding to collect
more data on monitoring the safe
use of these medicines in children
and to promote further research.
The period of public consultation
is open until 15 Apr- see
www.ema.europa.eu.The above article was sent to subscribers in Pharmacy Daily's issue from 24 Jan 11 To see the full newsletter, see the embedded issue below or CLICK HERE to download Pharmacy Daily from 24 Jan 11
from the fields Pharmaceutical (FTFP) is unveiling an information drive targeting community pharmacy, ahead of the 01 Mar commencement of new retail regulations for the sale and distribution of medically prescribed vaping products in pharmacies.