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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

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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

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
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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.

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.

EQS-News: Direct Sao Paulo to Gauteng flights opens a myriad of opportunities for Brazilian travelers

Retrieved on:

Wednesday, April 10, 2024

Since the launch, the flights have a more than 60% load factor which is expected to grow” said Sthembiso Dlamini GTA’s CEO.

Key Points:

Since the launch, the flights have a more than 60% load factor which is expected to grow” said Sthembiso Dlamini GTA’s CEO.
Within 9-10 hrs Brazilian travellers can immerse themselves in the rich tapestry of experiences that Gauteng offers – from its vibrant urban lifestyle to its stunning natural landscapes.
It is an invitation to explore the #GPLifestyle - a unique blend of adventure, culture, and cuisine that the province is renowned for.
Gauteng is known for top restaurants that provide a vast selection of cuisine from across the African continent and the globe.

ACELYRIN, INC. Reports Full Year 2023 Financial Results and Recent Highlights

Retrieved on:

Thursday, March 28, 2024

LOS ANGELES, March 28, 2024 (GLOBE NEWSWIRE) -- ACELYRIN, INC. (Nasdaq: SLRN), a late-stage clinical biopharma company focused on accelerating the development and delivery of transformative medicines in immunology, today reported financial results for the full year ended December 31, 2023 and highlighted recent corporate updates and upcoming milestones.

Key Points:

R&D Expenses: Research and development expenses were $355.9 million for the full year ended December 31, 2023, as compared to $55.6 million for 2022.
G&A Expenses: General and administrative expenses were $66.2 million for the full year ended December 31, 2023, as compared to $13.5 million for 2022.
Net Loss: Net loss for the full year ended December 31, 2023 was $381.6 million, compared to $64.8 million for 2022.
In December 2023, the Company announced the appointment of Lynn Tetrault to its Board of Directors.

Environmental Remediation Market to Reach $218.8 billion, Globally, by 2032 at 7.1% CAGR: Allied Market Research

Retrieved on:

Monday, April 8, 2024

PORTLAND, Ore., April 8, 2024 /PRNewswire/ -- Allied Market Research published a report, titled, "Environmental Remediation Market by Site-Type (Public and Private), Medium (Soil and Groundwater), Technology (Air Sparging, Soil Washing, Chemical Treatment, Bioremediation, Electrokinetic Remediation, Excavation, and Permeable Reactive Barriers), and Application (Mining & Forestry, Oil & Gas, Agriculture, Automotive, Landfills and Waste Disposal Sites, Manufacturing, Industrial, and Chemical Production/Processing, Construction and Land Development, Others): Global Opportunity Analysis and Industry Forecast, 2023-2032". According to the report, the "environmental remediation market" was valued at $110.7 billion in 2022, and is estimated to reach $218.8 billion by 2032, growing at a CAGR of 7.1% from 2023 to 2032.

Key Points:

The Russia-Ukraine war had significant implications on the environmental remediation market, affecting both the demand for remediation services and the resources available for environmental cleanup efforts.
As a result, there is an increased need for environmental remediation services to address these pollution incidents and mitigate their impacts.
Geopolitical tensions and economic sanctions stemming from the Russia-Ukraine war impact international cooperation and investment in environmental remediation initiatives.
Collaboration between countries and organizations on transboundary pollution issues and environmental cleanup projects are expected to be strained, leading to delays or disruptions in remediation efforts.

Environmental Remediation Market to Reach $218.8 billion, Globally, by 2032 at 7.1% CAGR: Allied Market Research

Retrieved on:

Monday, April 8, 2024

PORTLAND, Ore., April 8, 2024 /PRNewswire/ -- Allied Market Research published a report, titled, "Environmental Remediation Market by Site-Type (Public and Private), Medium (Soil and Groundwater), Technology (Air Sparging, Soil Washing, Chemical Treatment, Bioremediation, Electrokinetic Remediation, Excavation, and Permeable Reactive Barriers), and Application (Mining & Forestry, Oil & Gas, Agriculture, Automotive, Landfills and Waste Disposal Sites, Manufacturing, Industrial, and Chemical Production/Processing, Construction and Land Development, Others): Global Opportunity Analysis and Industry Forecast, 2023-2032". According to the report, the "environmental remediation market" was valued at $110.7 billion in 2022, and is estimated to reach $218.8 billion by 2032, growing at a CAGR of 7.1% from 2023 to 2032.

Key Points:

The Russia-Ukraine war had significant implications on the environmental remediation market, affecting both the demand for remediation services and the resources available for environmental cleanup efforts.
As a result, there is an increased need for environmental remediation services to address these pollution incidents and mitigate their impacts.
Geopolitical tensions and economic sanctions stemming from the Russia-Ukraine war impact international cooperation and investment in environmental remediation initiatives.
Collaboration between countries and organizations on transboundary pollution issues and environmental cleanup projects are expected to be strained, leading to delays or disruptions in remediation efforts.

Rose Hill Partners with University of Guelph for Groundbreaking Study to Advance Research for the Potential Benefits of Psilocybin Mushrooms to Address Autism in the Adolescent Brain

Retrieved on:

Thursday, March 21, 2024

This collaboration marks a significant milestone for both entities as they embark on a pioneering exploration of the potential benefits of psilocybin to address autism in the adolescent brain, the first-of-its-kind partnership in this space.

Key Points:

This collaboration marks a significant milestone for both entities as they embark on a pioneering exploration of the potential benefits of psilocybin to address autism in the adolescent brain, the first-of-its-kind partnership in this space.
The collaborative preclinical research will focus on exploring and standardizing the chemical diversity of Rose Hill’s psilocybin mushrooms, legally imported from Jamaica to Canada for the work.
Additionally, utilizing a rodent model, the study will investigate their potential application in Autism Spectrum Disorders (ASD).
Psilocybin mushrooms, known for their psychoactive properties, have long captivated the scientific community's interest due to their potential therapeutic applications and unique biochemical composition.

Psyence Biomedical Ltd. Issues Shareholder Letter Recapping Recent Progress and Outlining Key Future Milestones

Retrieved on:

Tuesday, March 12, 2024

Our merger with Newcourt and subsequent listing on Nasdaq confers numerous benefits to our company.

Key Points:

Our merger with Newcourt and subsequent listing on Nasdaq confers numerous benefits to our company.
While other companies are exploring synthetic psilocybin, Psyence is the world’s first Nasdaq traded biopharmaceutical company researching a nature-derived (non-synthetic) psilocybin candidate.
Furthermore, Psyence is the only publicly traded company to research a non-synthetic psilocybin candidate to treat Adjustment Disorder in the context of Palliative Care.
To reflect this exciting new chapter in our company’s evolution, we have created a new investor presentation, which can be found here .

Global Microbiome Manufacturing Markets 2023-2024 & 2035: Industry Trends, Forecasts, Formulation, Primary Packaging Used, Scale of Operation, Company Size, Key Regions and Leading Developers - ResearchAndMarkets.com

Retrieved on:

Friday, April 5, 2024

Likewise, the ecological system of commensal, symbiotic, and pathogenic microorganisms that reside within a host system is called the microbiome.

Key Points:

Likewise, the ecological system of commensal, symbiotic, and pathogenic microorganisms that reside within a host system is called the microbiome.
Further, this microbiome manufacturing market analysis highlights the efforts of several stakeholders engaged in this rapidly emerging segment of the pharmaceutical industry.
Around 43% of the global microbiome contract manufacturing capacity is installed in facilities owned by small contract manufacturing companies.
This market report includes an easily searchable excel database of all the microbiome contract manufacturing companies and their manufacturing facility, worldwide.

Regional Winners of 32nd Annual ExploraVision Competition Announced by Toshiba, National Science Teaching Association

Retrieved on:

Tuesday, April 2, 2024

Toshiba and the National Science Teaching Association (NSTA) announced today the regional winners of the 32nd annual ExploraVision program, the largest K-12 science competition designed to build problem-solving, critical thinking and collaboration skills that are central to the Next Generation Science Standards.

Key Points:

Toshiba and the National Science Teaching Association (NSTA) announced today the regional winners of the 32nd annual ExploraVision program, the largest K-12 science competition designed to build problem-solving, critical thinking and collaboration skills that are central to the Next Generation Science Standards.
This year’s regional winners’ projects include innovative ideas ranging from technology drones that help reduce the carbon footprint to technologies that ensure safety in emergency situations.
In the next phase of the competition, the 24 regional winners will advance to the national level.
All first- and second-place national winners will be formally recognized for their creativity and accomplishments at an ExploraVision awards ceremony in mid-June.