Medicinal plants

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

Retrieved on:

Thursday, April 18, 2024

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

8.
Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
EMA/HMPC/246816/2005
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7.
Where possible, stable varieties and cultivars naturally
Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
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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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270
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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

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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

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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.
143
144
145
150
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152
153
154

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163
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166
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168
169
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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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178
179
180
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185
186
187
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190
191
192

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.

Caffeine Powder Market to Reach $1,612.1 Million, Globally, by 2032 at 5.5% CAGR: Allied Market Research

Retrieved on:

Monday, April 8, 2024

Alertness, Health, Fatigue, Headache, Growth, Data, Drink, Migraine, Caffeine, Medicinal plants

WILMINGTON, Del., April 8, 2024 /PRNewswire/ -- Allied Market Research published a report, titled, "Caffeine Powder Market by Source (Synthetic Caffeine, Natural Caffeine), and Application (Food and Beverages, Pharmaceuticals, Cosmetics and Personal Care, Others): Global Opportunity Analysis and Industry Forecast, 2023-2032". According to the report, the "caffeine powder market" was valued at $949.4 million in 2022, and is estimated to reach $1,612.1 million by 2032, growing at a CAGR of 5.5% from 2023 to 2032.

Key Points:

Moreover, caffeine powder offers consumers the flexibility to customize their caffeine intake according to their preferences and needs.
In addition, the globalization of the caffeine powder market has led to increased accessibility and availability of products across regions and channels.
Furthermore, Europe is home to several prominent pharmaceutical and food industries that utilize caffeine powder in various formulations, further bolstering market growth.
With its robust market infrastructure, consumer demand, and regulatory framework, Europe is expected to maintain its leadership position in the global caffeine powder market.

Caffeine Powder Market to Reach $1,612.1 Million, Globally, by 2032 at 5.5% CAGR: Allied Market Research

Retrieved on:

Monday, April 8, 2024

Alertness, Health, Fatigue, Headache, Growth, Data, Drink, Migraine, Caffeine, Medicinal plants

WILMINGTON, Del., April 8, 2024 /PRNewswire/ -- Allied Market Research published a report, titled, "Caffeine Powder Market by Source (Synthetic Caffeine, Natural Caffeine), and Application (Food and Beverages, Pharmaceuticals, Cosmetics and Personal Care, Others): Global Opportunity Analysis and Industry Forecast, 2023-2032". According to the report, the "caffeine powder market" was valued at $949.4 million in 2022, and is estimated to reach $1,612.1 million by 2032, growing at a CAGR of 5.5% from 2023 to 2032.

Key Points:

Moreover, caffeine powder offers consumers the flexibility to customize their caffeine intake according to their preferences and needs.
In addition, the globalization of the caffeine powder market has led to increased accessibility and availability of products across regions and channels.
Furthermore, Europe is home to several prominent pharmaceutical and food industries that utilize caffeine powder in various formulations, further bolstering market growth.
With its robust market infrastructure, consumer demand, and regulatory framework, Europe is expected to maintain its leadership position in the global caffeine powder market.

Texas Original Announces Opening of Sugar Land Location, Launches New RSO Gummies

Retrieved on:

Wednesday, March 27, 2024

Texas Original , Texas’ leading medical cannabis provider, today announced the opening of its newest prescription pickup location in Sugar Land, Texas.

Key Points:

Texas Original , Texas’ leading medical cannabis provider, today announced the opening of its newest prescription pickup location in Sugar Land, Texas.
Texas Original also announced the launch of its new Pineapple Gummies, a 20 mg THC-only product made with Rick Simpson Oil (RSO).
Alongside the company’s recently launched Dark Chocolate Bites and RSO Tincture, Texas Original’s Pineapple Gummies are among the first medical cannabis products in the state—and the first gummy product—to incorporate RSO.
Texans can obtain medical cannabis prescriptions through online clinics or local physicians registered with the Compassionate Use Registry of Texas.

Banyan Botanicals and Peers Announce Collaboration to Reduce Carbon Emissions in Herbal Supply Chain

Retrieved on:

Tuesday, March 12, 2024

The group’s primary objective is to reduce carbon emissions in the herbal supply chain and improve environmental standards for the industry.

Key Points:

The group’s primary objective is to reduce carbon emissions in the herbal supply chain and improve environmental standards for the industry.
Facilitated by the Sustainable Herbs Program , this pre-competitive group working to establish accurate Scope 3 emissions data for herbal ingredients includes seven member companies: Banyan Botanicals, Nature’s Sunshine , Pure Synergy , Pukka Tea , Traditional Medicinals , Pacific Botanicals and Yogi .
What we do to the planet, we do to ourselves,” said Erin Douglas, Senior Social and Environmental Responsibility Manager at Banyan Botanicals.
This initiative also serves the broader goal of creating an accessible, scalable and standardized model for measuring herbal emissions across the industry.

Real Isolates and Sanctuary Medicinals Announce Launch of Smokenol™-Infused Product Lines

Retrieved on:

Tuesday, March 12, 2024

Temperature, Cannabinoid, Science, Partnership, Patient, Research, Smoke, Smoking, Medicinals, THC, Sanctuary, Medicinal plants

WOBURN, Mass., March 12, 2024 /PRNewswire/ -- Sanctuary Medicinals is pleased to announce an exciting new partnership with Real Isolates, utilizing their patented Smokenol™ cannabis smoke extraction process for infusion in select Sanctuary products.

Key Points:

WOBURN, Mass., March 12, 2024 /PRNewswire/ -- Sanctuary Medicinals is pleased to announce an exciting new partnership with Real Isolates, utilizing their patented Smokenol™ cannabis smoke extraction process for infusion in select Sanctuary products.
Partnering with Real Isolates is a perfect example of that commitment.
Co-Founder of Real Isolates, Andy Westerkamp, explains "Real Isolates and Sanctuary Medicinals prioritize quality of life for patients and consumers.
Alex Hildrith, Laboratory Director for Sanctuary adds, "Sanctuary's lab team is very excited to announce our official partnership with Real Isolates.

Herbal medicinal product: Curcumae longae rhizomaArray, C: ongoing call for scientific data

Retrieved on:

Wednesday, April 3, 2024

Date, Ethanol, Patient, Physiology, Committee, Flatulence, Stomach, Digestion, Monograph, Mouth, Herbal medicine, Medicine, Medicinal plants

Overview

Key Points:

Overview
This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of turmeric.
The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing turmeric.
Herbal medicines containing these turmeric preparations are usually available as herbal tea to be drunk and in solid or liquid forms to be taken by mouth.
Turmeric preparations may also be found in combination with other herbal substances in some herbal medicines.