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

Retrieved on:

Jeudi, avril 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

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

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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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147
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
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

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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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?

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320

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322

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325

?

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

Retrieved on:

Jeudi, avril 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.

Most Smoking Employees Gain Over Three Weeks of Paid Time Off Through Smoke Breaks According to New Study

Retrieved on:

Jeudi, avril 4, 2024

Research, Telecommunications, Smoker, Smoking, Environment, Tobacco

The study underscores the importance of promoting productive breaks among employees that do not significantly disrupt the workday.

Key Points:

The study underscores the importance of promoting productive breaks among employees that do not significantly disrupt the workday.
The study also showed that smoking at work exacerbates the difficulty of quitting, with over 60% of respondents citing workplace smoking as a barrier.
“The study revealed high smoking rates in industries such as retail, catering and leisure, IT and telecommunications, and healthcare.
To learn more about the global transformation of inspiring smokers to conscious enjoyment and explore smoke-free alternatives available across the US, visit www.nicokick.com .

Smith+Nephew’s PICO™ Single Use Negative Pressure Wound Therapy System provides better clinical outcomes versus standard of care according to UK National Institute for Health and Care Excellence (NICE)

Retrieved on:

Jeudi, avril 4, 2024

RCT, Pressure, Diabetes, Risk, Globalization, Patient, Area studies, Kidney disease, PICO, Senior, Smoking, Christianity in Singapore, SNN, BMI, Pharmaceutical industry

Smith+Nephew (LSE:SN, NYSE:SNN), the global medical technology company, today announces the review of medical technologies guidance from the UK National Institute for Health and Care Excellence (NICE) for its PICO Single Use Negative Pressure Wound Therapy System (sNPWT).

Key Points:

Smith+Nephew (LSE:SN, NYSE:SNN), the global medical technology company, today announces the review of medical technologies guidance from the UK National Institute for Health and Care Excellence (NICE) for its PICO Single Use Negative Pressure Wound Therapy System (sNPWT).
NICE have reviewed ‘Medical Technology Guideline 43 PICO negative pressure wound dressings for closed surgical incisions’ which recognises that Smith+Nephew’s PICO sNPWT provides better clinical outcomes than standard dressings in patients at high risk of surgical site infections (SSIs), at similar overall cost.
The 24 clinical studies included a total of 7,790 patients with PICO sNPWT being used in 3,754.
NICE concluded that PICO sNPWT is associated with fewer SSIs and seromas compared with standard wound dressings.

Achieve Life Sciences Reports Financial Results for Fourth Quarter and Year-End 2023 and Provides Corporate Update

Retrieved on:

Jeudi, mars 28, 2024

Research, Herbal cigarette, Exercise, Webcast, Risk, International, Nicotine, NDA, Society, Abstract, Smoking, Safety, FDA, Food, Pharmaceutical industry

Results presented from the Phase 3 participant surveys, showed that 69% of survey respondents who received cytisinicline reported quitting smoking completely.

Key Points:

Results presented from the Phase 3 participant surveys, showed that 69% of survey respondents who received cytisinicline reported quitting smoking completely.
For those on treatment that did not achieve full smoking abstinence, 22% reported a reduction of their smoking by over half.
Total operating expenses for the fourth quarter and year ended December 31, 2023 were $4.4 million and $27.3 million, respectively.
Total net loss for the fourth quarter and year ended December 31, 2023 was $5.5 million and $29.8 million, respectively.

Qnovia, Inc. Announces the Appointment of Four New Members to its Scientific Advisory Board

Retrieved on:

Mardi, avril 9, 2024

“We believe our proprietary drug-device combination platform has the potential to be a first-in-class and best-in-class treatment for smoking cessation.

Key Points:

“We believe our proprietary drug-device combination platform has the potential to be a first-in-class and best-in-class treatment for smoking cessation.
Last fall, QN-01 demonstrated a superior pharmacokinetic profile compared to existing nicotine replacement therapies in our first-in-human Phase 1 clinical trial.
We plan to submit our IND and CTA to the regulatory bodies and look forward to commencing our Phase 1/2 clinical study this year.
He also served a three-year term on the Board of the Society for Research on Nicotine and Tobacco.

Innovation Meets Regulation: International Webinar Explored Effective Anti-Smoking Strategies

Retrieved on:

Mardi, avril 9, 2024

We Are Innovation hosted the webinar “ Innovation Meets Regulation: The 2024 Effective Anti-Smoking Policies Global Index .” This powerful talk embarked on the official start of the campaign dedicated to the launch of the anti-smoking index .

Key Points:

We Are Innovation hosted the webinar “ Innovation Meets Regulation: The 2024 Effective Anti-Smoking Policies Global Index .” This powerful talk embarked on the official start of the campaign dedicated to the launch of the anti-smoking index .
The webinar, featuring Members of the European Parliament, regulatory experts, economists, and innovation experts, shed light on the regulatory frameworks regarding anti-smoking policies from the most prominent global authorities in the field.
View the full release here: https://www.businesswire.com/news/home/20240408705665/en/
Federico N. Fernández stated, “At We Are Innovation, we work on issues that require innovative approaches and solutions.
By embracing a forward-thinking approach, we can effectively address the problem of smoking,” summed up Tetiana Rak.

New Virtual Companionship Program from Homethrive Tackles Social Isolation and Empowers Older Adults

Retrieved on:

Mardi, avril 9, 2024

Research, Depression, Health, Obesity, Trust, Ageing, Social isolation, Transport, Anxiety, Death, Loneliness, Smoking, Safety, Tourism

NORTHBROOK, Ill., April 9, 2024 /PRNewswire/ -- Homethrive, a high-tech, high-touch family caregiving support platform, today announced the launch of its Virtual Companionship solution that will help address the issue of social isolation and loneliness among older adults.

Key Points:

NORTHBROOK, Ill., April 9, 2024 /PRNewswire/ -- Homethrive, a high-tech, high-touch family caregiving support platform, today announced the launch of its Virtual Companionship solution that will help address the issue of social isolation and loneliness among older adults.
Research shows nearly one-fourth of U.S. adults aged 65 and older are socially isolated.
The health impact of this isolation can rival the consequences of smoking , obesity and low physical activity.
"America is experiencing a loneliness epidemic, and older adults are among the most vulnerable," said David Greenberg, co-founder and co-CEO of Homethrive.

Diablo Tools Takes the Heat and the Plunge with AMPED™ Demo Demon™ Carbide Teeth Oscillating Multi-Tool (OMT) Blade for Nail-Embedded Wood

Retrieved on:

Mardi, avril 9, 2024

Vibration, Burns, OMT, Risk, The Home Depot, Black, Wood, Smoking, Universal, Nail

ATLANTA, April 9, 2024 /PRNewswire/ -- Diablo Tools ("Diablo"), which offers a solution-oriented range of best-in-the-world and best-for-our-world products for the professional user, introduces yet another industry-first in the oscillating multi-tool ("OMT") market: the AMPED™ Demo Demon™ Carbide Teeth Blade for Nail-Embedded Wood. This first-of-its-kind carbide OMT blade is designed specifically for nail-embedded wood and offers never before seen application-specific benefits and game-changing innovations for professionals.

Key Points:

This first-of-its-kind carbide OMT blade is designed specifically for nail-embedded wood and offers never before seen application-specific benefits and game-changing innovations for professionals.
Diablo's AMPED™ Demo Demon™ Carbide Teeth OMT Blade is the first application-specific carbide blade for wood containing nails, screws, and other fasteners.
A game-changing, user-focused design also plays a role in elevating the AMPED™ Demo Demon™ Carbide Teeth OMT blade.
Diablo's AMPED™ Demo Demon™ Carbide Oscillating Blades for Nail-Embedded Wood are available now wherever Diablo products are sold – including The Home Depot and independent retailers.

New Campaign Highlights How Certain Jobs Can Increase a Person's Risk for Lung Disease

Retrieved on:

Mardi, avril 9, 2024

CHICAGO, April 9, 2024 /PRNewswire/ -- Chronic obstructive pulmonary disease (COPD) impacts 11.7 million people living in the U.S. While smoking is a significant risk factor for the disease, long-term exposure to dust, chemicals, fumes and vapors from the workplace may also lead to COPD. To help people identify workplace risk factors and encourage them to speak with their healthcare provider if they are experiencing symptoms, the American Lung Association is launching a campaign to raise awareness for occupational COPD.

Key Points:

While smoking is a significant risk factor for the disease, long-term exposure to dust, chemicals, fumes and vapors from the workplace may also lead to COPD.
COPD, which includes chronic bronchitis and emphysema, is a long-term lung disease that makes it hard to breathe.
Many workplaces may expose workers to risk factors for COPD, but the leading job types that increase risk for chronic lung disease include agriculture, mining and manufacturing.
Early treatment of a chronic lung disease, including reducing the exposure, can help lead to better health outcomes.