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Draft guideline on good agricultural and collection practice (GACP) for starting materials of herbal origin - Revision 1

Retrieved on:

Thursday, April 18, 2024

Reproduction, SCOPE, Eating, Pesticide, Convention, Change control, Confusion, Alkaloid, Climate, Fungus, Directive (European Union), Ethylene oxide, Wind, Wood, Glass, European Medicines Agency, HMPS, QDG, Hygiene, Water, Marketing, Fertilizer, Legislation, Manure, Distillation, Risk, Education, Committee, Compost, Draft, Policy, Person, EMA, Seed, Polycyclic aromatic hydrocarbon, Collection, Freezing, GMP, Risk assessment, GACP, Sunlight, Fermentation, Personal protective equipment, Animal, Herbal, Herbicide, Weather, INTRODUCTION, Documentation, Regeneration, Decontamination, EudraLex, Disease, International trade, European Pharmacopoeia, Part, Livestock, Public, Inhalation, Knowledge, Seedling, Factorization of polynomials, Record, Plant, Skin, API, Irrigation, Part Two, Soil, Directive, Pharmacopoeia, Codex, Guideline, Temperature, Attention, Hydrocarbon, Pyrrolizidine alkaloid, Polychlorinated biphenyl, Growth, Rotation, Incineration, Environment, Humidity, Smell, Ventilation, Light, Bird, Mineral, Fumigation, Pyrrolizidine, SOP, Housing, Smoking, Atmosphere, Postharvest, Rain, Liver, QWP, Medicinal plants

REFERENCES ....................................................................................................................................... 14

Key Points:

REFERENCES ....................................................................................................................................... 14
29

Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
EMA/HMPC/246816/2005

Page 3/14

30

EXECUTIVE SUMMARY

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32
33
34
35
36

This guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin

37

1.
Due to the inherent
complexity of medicinal plants and herbal substances the quality of these starting materials requires an
adequate quality assurance system for the collection and/or cultivation, harvest, and primary
processing.
(either outdoor, indoor or in greenhouses) should be carefully considered, since each of the mentioned
types could have several problems and advantages.
The used cultivation method may be dependent on
the final application of the herbal medicinal product.
primary processing of herbal substances that are used for the preparation of herbal medicinal products.
medicinal plants and herbal substances, ensuring that they are handled appropriately throughout all
stages of cultivation, collection, processing and storage.
their preparations are exposed to a large number of environmental contaminants of both biotic and
abiotic origin.
to existing wildlife habitats and must adhere to CITES (Convention on International Trade in
Endangered species of Wild Fauna and Flora).
https://health.ec.europa.eu/document/download/bd537ccf-9271-4230-bca1-2d...
4 https://health.ec.europa.eu/document/download/fd318dd6-2404-4e67-82b0232...
3
Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
EMA/HMPC/246816/2005

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104

4.
Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
EMA/HMPC/246816/2005
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148
149

8.
Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
EMA/HMPC/246816/2005
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185

7.
Where possible, stable varieties and cultivars naturally
Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
EMA/HMPC/246816/2005
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227
228

resistant or tolerant to disease should preferably be used.
Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
EMA/HMPC/246816/2005
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268
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271
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273

The application should be carried out only by qualified staff using approved equipment.
The following should be noted:
Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
EMA/HMPC/246816/2005

Page 10/14

309
310

?

311
312
313

?

314
315
316
317

?

318
319
320

?

321
322

?

323
324
325

?

326
327
328

?

Damaged plants or plant parts need to be excluded or limited in accordance with a specific
pharmacopoeia monograph, where relevant.
Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
EMA/HMPC/246816/2005
Page 11/14

347
348

directly to the sun (except in cases where there is a specific need) and must be protected from
rainfall, insect infestation, etc.
The label must be clear, permanently fixed and made from
6

Reflection paper on the use of fumigants (EMEA/HMPC/125562/2006)

Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
EMA/HMPC/246816/2005

Page 12/14

386
387

non-toxic material.
Certain exudates that have not been subjected to a specific treatment are
Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
EMA/HMPC/246816/2005

Page 13/14

425
426
427

also considered to be herbal substances.
European Pharmacopoeia General Monograph ?HERBAL DRUGS? 07/2017:1433
Are obtained by subjecting herbal substances to treatments such as
extraction, distillation, expression, fractionation, purification, concentration
or fermentation.

Template for a European Union herbal monograph

Retrieved on:

Thursday, April 18, 2024

Key Points:

Draft guideline on good agricultural and collection practice (GACP) for starting materials of herbal origin - Revision 1

Retrieved on:

Thursday, April 18, 2024

REFERENCES ....................................................................................................................................... 14

Key Points:

REFERENCES ....................................................................................................................................... 14
29

Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
EMA/HMPC/246816/2005

Page 3/14

30

EXECUTIVE SUMMARY

31
32
33
34
35
36

This guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin

37

1.
Due to the inherent
complexity of medicinal plants and herbal substances the quality of these starting materials requires an
adequate quality assurance system for the collection and/or cultivation, harvest, and primary
processing.
(either outdoor, indoor or in greenhouses) should be carefully considered, since each of the mentioned
types could have several problems and advantages.
The used cultivation method may be dependent on
the final application of the herbal medicinal product.
primary processing of herbal substances that are used for the preparation of herbal medicinal products.
medicinal plants and herbal substances, ensuring that they are handled appropriately throughout all
stages of cultivation, collection, processing and storage.
their preparations are exposed to a large number of environmental contaminants of both biotic and
abiotic origin.
to existing wildlife habitats and must adhere to CITES (Convention on International Trade in
Endangered species of Wild Fauna and Flora).
https://health.ec.europa.eu/document/download/bd537ccf-9271-4230-bca1-2d...
4 https://health.ec.europa.eu/document/download/fd318dd6-2404-4e67-82b0232...
3
Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
EMA/HMPC/246816/2005

Page 5/14

104

4.
Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
EMA/HMPC/246816/2005
Page 6/14

147
148
149

8.
Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
EMA/HMPC/246816/2005
Page 7/14

185

7.
Where possible, stable varieties and cultivars naturally
Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
EMA/HMPC/246816/2005
Page 8/14

227
228

resistant or tolerant to disease should preferably be used.
Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
EMA/HMPC/246816/2005
Page 9/14

268
269
270
271
272
273

The application should be carried out only by qualified staff using approved equipment.
The following should be noted:
Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
EMA/HMPC/246816/2005

Page 10/14

309
310

?

311
312
313

?

314
315
316
317

?

318
319
320

?

321
322

?

323
324
325

?

326
327
328

?

Damaged plants or plant parts need to be excluded or limited in accordance with a specific
pharmacopoeia monograph, where relevant.
Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
EMA/HMPC/246816/2005
Page 11/14

347
348

directly to the sun (except in cases where there is a specific need) and must be protected from
rainfall, insect infestation, etc.
The label must be clear, permanently fixed and made from
6

Reflection paper on the use of fumigants (EMEA/HMPC/125562/2006)

Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
EMA/HMPC/246816/2005

Page 12/14

386
387

non-toxic material.
Certain exudates that have not been subjected to a specific treatment are
Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
EMA/HMPC/246816/2005

Page 13/14

425
426
427

also considered to be herbal substances.
European Pharmacopoeia General Monograph ?HERBAL DRUGS? 07/2017:1433
Are obtained by subjecting herbal substances to treatments such as
extraction, distillation, expression, fractionation, purification, concentration
or fermentation.

Draft template for assessment report for the development of European herbal monographs and European Union list entries - Revision 6

Retrieved on:

Thursday, April 18, 2024

The completed comments form should be sent to

Key Points:

The completed comments form should be sent to
[email protected]
10
11
Keywords
Committee 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 report

12

1
2

Changes 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

25

.
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 ........................................................... 16
97
98

3.3.
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.
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154

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Herbal 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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Additional 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
227

232

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 of

preparation

administration

Posology, age
groups,
pharmaceutical
form, method of
administration,
duration of use
As reported in
the market
overview

As reported in
the market
overview

As 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
administration

Posology, age
groups,
pharmaceutical
form, method of
administration,
duration of use

Regulatory Status

Type of
regulatory
status where
possible, date,
Country

287

This overview is not exhaustive.
Clinical Safety/Pharmacovigilance
836
837
838
839
840
841

See ?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
1104

The 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.

DAVIDsTEA Launches “Tea-2-Go” at over 1,500 Couche-Tard/Circle K Stores Across Canada

Retrieved on:

Tuesday, March 19, 2024

Cream, DTEA, Partnership, Gastrointestinal tract, Transport, Alimentation Couche-Tard, DavidsTea, TSX, Drink, Snack, Herbal, Tea

In addition, DAVIDsTEA will establish a full tea bar concept at seven Couche-Tard stores to offer a wide variety of hot and iced teas.

Key Points:

In addition, DAVIDsTEA will establish a full tea bar concept at seven Couche-Tard stores to offer a wide variety of hot and iced teas.
“We are proud to become the exclusive supplier of high-quality teas across Canada to an industry leader like Couche-Tard,” said Sarah Segal, Chief Executive Officer and Chief Brand Officer, DAVIDsTEA.
“This landmark agreement enables DAVIDsTEA to introduce a whole new segment of customers to our wide variety of flavourful teas.
We are very pleased with this new partnership,” said Daniel Lapalme, Foodservice Director, Eastern Canada Division, Alimentation Couche-Tard.

Global Immune Health Supplements Outlook Report 2024: Market to Reach $34.73 Billion by 2028 with Amway, Bayer, DSM, Glanbia, Herbalife Nutrition, and Nutramax Laboratories Dominating - ResearchAndMarkets.com

Retrieved on:

Thursday, March 28, 2024

The global immune health supplements market was valued at $20.80 billion in 2022 and is expected to reach $34.73 billion by 2028, growing at a CAGR of 8.92%

Key Points:

The global immune health supplements market was valued at $20.80 billion in 2022 and is expected to reach $34.73 billion by 2028, growing at a CAGR of 8.92%
The global immune health supplements market is witnessing several dynamic changes after the Coronavirus surge worldwide.
In the global immune health supplements market, several leading domestic, national, and international vendors are present.
North America accounted for the highest global immune health supplements market share, accounting for over 33% in 2022.
High Demand for Immune Health Supplements with Zinc, Vitamin C & D, and Curcumins
In the immune health supplements market, vitamin C, vitamin D, zinc, and curcumins are the most used and suggested ingredients for immune health.

Wanglaoji Accelerates International Market Expansion by Launching the International Brand Identity WALOVI in Thailand

Retrieved on:

Saturday, March 30, 2024

Health, Guangzhou Pharmaceuticals, Party, Multimedia, Herbal, Tea

GUANGZHOU, China, March 30, 2024 /PRNewswire/ -- On March 30, in Bangkok, Thailand, Guangzhou Pharmaceutical Holdings Limited (GPHL) held a ceremony for signing up Wanglaoji (Bangkok) Herbal Tea Museum and launching Wanglaoji international brand identity (Bangkok).

Key Points:

GUANGZHOU, China, March 30, 2024 /PRNewswire/ -- On March 30, in Bangkok, Thailand, Guangzhou Pharmaceutical Holdings Limited (GPHL) held a ceremony for signing up Wanglaoji (Bangkok) Herbal Tea Museum and launching Wanglaoji international brand identity (Bangkok).
This event aims at being based on Thailand, radiating to Southeast Asia, promoting further internationalization of Wanglaoji herbal tea.
1 natural plant drink brand in the world, Wanglaoji launched the international brand identity WALOVI to accelerate its pace of internationalization.
The Southeast Asian market is a key overseas sales market for Wanglaoji.

Wanglaoji Accelerates International Market Expansion by Launching the International Brand Identity WALOVI in Thailand

Retrieved on:

Saturday, March 30, 2024

Health, Guangzhou Pharmaceuticals, Party, Herbal, Tea

GUANGZHOU, China, March 30, 2024 /PRNewswire/ -- On March 30, in Bangkok, Thailand, Guangzhou Pharmaceutical Holdings Limited (GPHL) held a ceremony for signing up Wanglaoji (Bangkok) Herbal Tea Museum and launching Wanglaoji international brand identity (Bangkok).

Key Points:

GUANGZHOU, China, March 30, 2024 /PRNewswire/ -- On March 30, in Bangkok, Thailand, Guangzhou Pharmaceutical Holdings Limited (GPHL) held a ceremony for signing up Wanglaoji (Bangkok) Herbal Tea Museum and launching Wanglaoji international brand identity (Bangkok).
This event aims at being based on Thailand, radiating to Southeast Asia, promoting further internationalization of Wanglaoji herbal tea.
1 natural plant drink brand in the world, Wanglaoji launched the international brand identity WALOVI to accelerate its pace of internationalization.
Among them, the Thailand market is highly recognized for outstanding performance and is expected to maintain rapid development momentum this year.

CSE Bulletin: Consolidation - Herbal Dispatch Inc. (HERB)

Retrieved on:

Tuesday, February 20, 2024

Herbal, Nightclub

Toronto, Ontario--(Newsfile Corp. - Le 20 février/February 2024) - Herbal Dispatch Inc. has announced a consolidation of its issued and outstanding common shares on the basis of one (1) post-consolidated common share for every ten (10) pre-consolidated common shares.

Key Points:

Toronto, Ontario--(Newsfile Corp. - Le 20 février/February 2024) - Herbal Dispatch Inc. has announced a consolidation of its issued and outstanding common shares on the basis of one (1) post-consolidated common share for every ten (10) pre-consolidated common shares.
As a result, the outstanding shares of the company will be reduced to approximately 73,627,909 common shares.
Herbal Dispatch Inc. a annoncé une consolidation de ses actions ordinaires émises et en circulation sur la base d'une (1) action ordinaire post-consolidée pour dix (10) actions ordinaires pré-consolidées.
Il est rappelé aux concessionnaires de ré-saisir leurs commandes en tenant compte de la consolidation des actions.

Wellnesszing Introduces New Online Magazine, Elevating Insights on Organic Lifestyle Trends

Retrieved on:

Friday, February 23, 2024

Anxiety, Cosmetics, Beauty, Ethics, Ageing, Skin, Skin care, Health, Safety, Yoga, Herbal, Propaganda, Meditation, Editorial, Interior design

San Francisco, CA, Feb. 22, 2024 (GLOBE NEWSWIRE) -- Wellnesszing, an online platform, is excited to announce the launch of its new online magazine, providing useful information and insights on living an organic, healthy, and sustainable lifestyle.

Key Points:

San Francisco, CA, Feb. 22, 2024 (GLOBE NEWSWIRE) -- Wellnesszing, an online platform, is excited to announce the launch of its new online magazine, providing useful information and insights on living an organic, healthy, and sustainable lifestyle.
The newly introduced WellnessZing magazine serves as an educational hub, aimed at helping people lead healthier and more balanced lives through adopting an organic lifestyle.
Specifically, readers can find useful information and tips on incorporating organic solutions into their self-care routines and daily habits.
For more on Wellnesszing’s new online magazine and organic lifestyle content, visit wellnesszing.com.