Draft template for assessment report for the development of European herbal monographs and European Union list entries - Revision 6
The completed comments form should be sent to
- The completed comments form should be sent to
[email protected]
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KeywordsCommittee on Herbal Medicinal Products; HMPC; European Union herbal
monographs; European Union list of herbal substances, preparations and
combinations thereof for use in traditional herbal medicinal products; herbal
medicinal products; traditional herbal medicinal products; traditional use;
well-established medicinal use; benefit-risk assessment; assessment report12
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2Changes introduced in section 6 Overall conclusions.
- Peer-reviewer
If not the same peer-reviewer
since last version, all peerreviewers should be listed, and
the version specified in
brackets. - 22
23
on
. - It is a working
24
document, not yet edited, and shall be further developed after the release for consultation of the
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. - The principle of the template is to make clear
distinctions between presentation of data (methodology and results)
and the assessment of the data (?assessor?s comment?). - likely from an article but it seems it is concluded by
the rapporteur; ?According to the author? to be added. - Chapters with
a heading including the word ?conclusion? should include a summary
of all critical assessment of the assessor for that particular
chapter. - If an assessor?s comment is not needed, the Rapporteur
should delete the box inserted in the template. - ?
The report should be sufficiently detailed to allow for secondary
assessment of the available data by other HMPC experts. - Overview of available pharmacokinetic data regarding the herbal substance(s), herbal
preparation(s) and relevant constituents thereof ........................................................... 1697
983.3.
- Overall conclusions on clinical pharmacology and efficacy ........................................ 27
Assessment report on
EMA/HMPC/418902/2005 Page 4/41
119
5.
- This sections is related to
available quality standards and there is no need to repeat information
on all preparations included in the monograph. - Search and assessment methodology
161
The Rapporteur shall undertake a comprehensive search of relevant
scientific literature and articles, Acts of law and regulations and
other relevant sources. - Cross-reference to the list of
references in Annex, which should list separately the references
supporting the assessment report. - 143
144
145150
151
152
153
154162
163
164
165
166
167
168
169
170
171
172
173
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175Herbal substance(s)
Herbal preparation(s)
Relevant constituents for this assessment report
Examples of scientific databases to be searched are Medline, PubMed,
Cochrane Database of Systematic Reviews, EMBASE etc. - Assessment report on
EMA/HMPC/418902/2005 Page 6/41
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177
178
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182
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184
185
186
187
188
189
190
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192Additional relevant references could also be retrieved from the checked
references. - Examples of books are Hagers Handbuch, The Complete German
Commission E Monographs, PDR for herbal medicines etc. - In addition, information from non-EU regulatory
authorities for examples Health Canada monographs or WHO monographs
could be searched, if relevant to herbal substances and preparations in
EU. - 221
225
226
227232
When the assessment report is revised, the rapporteur should briefly
summarise the main changes under this section. - Data are collected using the template entitled ?Document
for information exchange for the preparation of the assessment report
for the development of European Union monographs and for inclusion of
herbal substance(s), preparation(s) or combinations thereof in the
list? (EMEA/HMPC/137093/2006). - Assessment report on
EMA/HMPC/418902/2005 Page 8/41
Herbal substance/
Indication
Posology and
method ofpreparation
administration
Posology, age
groups,
pharmaceutical
form, method of
administration,
duration of use
As reported in
the market
overviewAs reported in
the market
overviewAs reported in
the market
overview. - Assessment report on
EMA/HMPC/418902/2005 Page 10/41
Herbal substance/
Indication/Medicinal
Posology and
preparation
use
method of
administrationPosology, age
groups,
pharmaceutical
form, method of
administration,
duration of useRegulatory Status
Type of
regulatory
status where
possible, date,
Country287
This overview is not exhaustive.
- Clinical Safety/Pharmacovigilance
836
837
838
839
840
841See ?Assessment of clinical safety and efficacy in the preparation of
EU herbal monographs for well-established and traditional herbal
medicinal products?(EMA/HMPC/104613/2005) for further details. - Overall conclusions on clinical safety
1067
1068
In terms of structure, the conclusion should follow the presentation of
the results above. - Overall conclusions
1092
1093
1101
Describe key aspects only briefly, these will already have been
described in detail in the respective sections. - This section should
cover all recommended ?well-established use? and ?traditional use?
indications and conclusions shall be provided for each therapeutic
indication and each herbal preparation. - 1102
Well established use monograph
1103
1104The clinical studies supporting well-established use should be
specified for each therapeutic indication and each herbal preparation. - The choice for the wording of traditional use indications vis-?vis existing wordings in monographs in the same therapeutic area should
be briefly discussed/justified. - 1153
List entry
1154
The conclusions should include a statement pointing to the
possibility/non-possibility to support a European Union list entry.