In addition, a definition for the
method of preparation is needed, since there are
different levels in the modification which cannot be
judged without explanation. This is crucial because
researchers can skip pre-clinical studies using traditional
efficacy data if the interested modified herbal
medicines are omitted by reasonable criteria.
Quality control assessments must be based on
explicit identification and characterization of the
constituents. There are some published guidelines for
quality control of herbal medicines or related materials
(WHO Regional Office for the Western Pacific 1993;
WHO 1998), however, the WHO indicated that lack of
appropriate mechanisms for control of herbal medicines
is one of main difficulties faced byWHOmember
countries. Also, general guidelines for research and
evaluation of traditional medicines and workshops
must be supported sufficiently (WHO 2005). In the
same year,WHO guidelines about information needed
to support clinical trials of herbal products was
launched, and introduced chemistry–manufacturing–
control (CMC). This operational guidance provides the
information needed before clinical studies of herbal
products are undertaken, such as specification and
amount of active ingredients, as well as analytical
procedures for chemical fingerprint and active compounds,
which can be used as general guidelines for
herbal medicines quality control (WHO Special
Programme for Research and Training in Tropical
Diseases 2005). Moreover, the updated version of the
quality control methods for herbal materials was
published including an annex describing good practices
for pharmaceutical quality control laboratories
(WHO 2011). As it is necessary to strengthen the
evidence base of traditional herbal medicines using
clinical trials, CMC promotes herbal medicine reproducibility.
Therefore, an evaluation of the clinical
efficacy ofTMbecomes more trustworthy when herbal
products and materials meet CMC criteria.
In addition, a definition for the
method of preparation is needed, since there are
different levels in the modification which cannot be
judged without explanation. This is crucial because
researchers can skip pre-clinical studies using traditional
efficacy data if the interested modified herbal
medicines are omitted by reasonable criteria.
Quality control assessments must be based on
explicit identification and characterization of the
constituents. There are some published guidelines for
quality control of herbal medicines or related materials
(WHO Regional Office for the Western Pacific 1993;
WHO 1998), however, the WHO indicated that lack of
appropriate mechanisms for control of herbal medicines
is one of main difficulties faced byWHOmember
countries. Also, general guidelines for research and
evaluation of traditional medicines and workshops
must be supported sufficiently (WHO 2005). In the
same year,WHO guidelines about information needed
to support clinical trials of herbal products was
launched, and introduced chemistry–manufacturing–
control (CMC). This operational guidance provides the
information needed before clinical studies of herbal
products are undertaken, such as specification and
amount of active ingredients, as well as analytical
procedures for chemical fingerprint and active compounds,
which can be used as general guidelines for
herbal medicines quality control (WHO Special
Programme for Research and Training in Tropical
Diseases 2005). Moreover, the updated version of the
quality control methods for herbal materials was
published including an annex describing good practices
for pharmaceutical quality control laboratories
(WHO 2011). As it is necessary to strengthen the
evidence base of traditional herbal medicines using
clinical trials, CMC promotes herbal medicine reproducibility.
Therefore, an evaluation of the clinical
efficacy ofTMbecomes more trustworthy when herbal
products and materials meet CMC criteria.
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