Regeneration

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

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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

      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

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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

      Page 9/14

      268
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      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 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.

Olympic Games 2024: France faces serious hurdles in the race to create a meaningful legacy

Retrieved on: 
Wednesday, April 10, 2024

Paris hosting the Olympic and Paralympic Games this summer provides France with a huge geopolitical opportunity.

Key Points: 
  • Paris hosting the Olympic and Paralympic Games this summer provides France with a huge geopolitical opportunity.
  • Former French president François Hollande was credited with instigating the successful bid to stage the 2024 Games, 100 years after Paris was last host in 1924.
  • But it is Emmanuel Macron who has enjoyed taking up the mantle in his quest to present a new vision of France.
  • Some believe Macron being president was just what the Games needed, given his apparent quest to transform France into a more outward-looking, progressive nation.
  • Indeed, Macron has proved adept at playing soft power games through sport (including his efforts to keep the footballer Kylian Mbappé playing in France).

City of light (and dark)

  • Elsewhere, in a city that struggles to cope with traffic density, transport arrangements and problems with accommodation are worrying some officials as the Olympics approaches.
  • By the end of September, it could be that many people across the world have a much more positive view of France and its capital city.
  • Problems are mounting that could well undermine one of the president’s cornerstone projects in projecting his vision of a new France.


The authors do not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and have disclosed no relevant affiliations beyond their academic appointment.

EQS-News: HepaRegeniX publishes data for its first-in-class MKK4 inhibitor HRX-215 for the treatment of acute and chronic liver diseases in Cell

Retrieved on: 
Wednesday, April 10, 2024

HRX-215 is a small molecule inhibitor of Mitogen-Activated Protein (MAP) Kinase Kinase 4 (MKK4).

Key Points: 
  • HRX-215 is a small molecule inhibitor of Mitogen-Activated Protein (MAP) Kinase Kinase 4 (MKK4).
  • "The positive results in terms of safety and tolerability confirm our intention to soon offer a drug that has the potential to revolutionize the treatment of severe liver diseases.
  • The data pave the way for further Phase II studies evaluating the efficacy of HRX-215 in humans," emphasizes Dr. Wolfgang Albrecht, COO of HepaRegeniX.
  • Further, HRX-215 was also able to protect hepatocytes from cell death in a model for acute liver injury.

Sustainable Green Team, Ltd. (SGTM) Signs Letter-of-Intent with Caribbean Partner to Expand Its Global Presence in 4 Caribbean Islands

Retrieved on: 
Tuesday, April 9, 2024

Under the terms of the LOI, Sustainable Green Team, Ltd .

Key Points: 
  • Under the terms of the LOI, Sustainable Green Team, Ltd .
  • will grant its exclusive right to manufacture, distribute, and sell its flagship products, HUMISOIL® , XLR8®Bio , and other mutually agreed-upon products in the designated territories.
  • At the same time, the Partner will pay SGTM a revenue share or licensing fee for any products the Partner manufactures.
  • The Caribbean Partner's expertise and local presence in the designated territories will play a significant role in driving the success of this agreement."

Surrozen Publishes Study in 'Respiratory Research' Demonstrating the Promise of a Wnt Mimetic Antibody in Treating Pulmonary Fibrosis

Retrieved on: 
Wednesday, April 3, 2024

SOUTH SAN FRANCISCO, Calif., April 03, 2024 (GLOBE NEWSWIRE) -- Surrozen, Inc. (Nasdaq: SRZN), a company pioneering targeted therapeutics that selectively modulate the Wnt pathway for tissue repair and regeneration, announced today publication of data in Respiratory Research highlighting the potential for Surrozen’s Wnt mimetic technologies to treat serious lung diseases like idiopathic pulmonary fibrosis (IPF) https://respiratory-research.biomedcentral.com/articles/10.1186/s12931-0.... The results observed with systemic administration of Surrozen’s Wnt mimetic antibody in an acute bleomycin model of pulmonary fibrosis demonstrate a Wnt pathway mediated decrease in inflammation and fibrosis and improvement in lung function.

Key Points: 
  • The results observed with systemic administration of Surrozen’s Wnt mimetic antibody in an acute bleomycin model of pulmonary fibrosis demonstrate a Wnt pathway mediated decrease in inflammation and fibrosis and improvement in lung function.
  • Idiopathic pulmonary fibrosis (IPF) is an interstitial lung disease characterized by areas of myofibroblast accumulation and extracellular matrix (ECM) deposition, disruption of alveolar architecture, and restricted lung physiology.
  • In pulmonary fibrosis, multiple cell types may need to be targeted to provide a regenerative environment facilitating repair.
  • “This work published in Respiratory Research represents a breakthrough in understanding the role of the Wnt pathway in lung fibrosis and the potential for Wnt mimetics to reduce fibrosis and improve lung function.”

Biomea Fusion Highlights Initial Data from the First Two Type 1 Diabetes Patients Dosed with BMF-219

Retrieved on: 
Monday, April 1, 2024

REDWOOD CITY, Calif., April 01, 2024 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea”) (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to discovering and developing oral covalent small molecules to treat and improve the lives of patients with metabolic diseases and genetically defined cancers, today announced initial response data from the first two type 1 diabetes patients treated with BMF-219 in the ongoing Phase II study (COVALENT-112).

Key Points: 
  • “We are very excited to announce the initial response data from the first two type 1 diabetes patients enrolled in the COVALENT-112 study.
  • Both patients showed improvement in measures of beta-cell function after only 4 weeks of dosing with BMF-219.
  • The trial includes an open label portion for adults with type 1 diabetes up to 15 years since diagnosis.
  • It has been exciting to participate in this study and explore this new pathway for the benefit of our patients.

Surrozen Announces up to $192.5 Million Private Placement of Securities Priced At-the-Market Under Nasdaq Rules

Retrieved on: 
Monday, April 1, 2024

SOUTH SAN FRANCISCO, Calif., April 01, 2024 (GLOBE NEWSWIRE) -- Surrozen, Inc. (“Surrozen” or the “Company”) (Nasdaq: SRZN, SRZNW), a company pioneering targeted therapeutics that selectively activate the Wnt Pathway for tissue repair and regeneration, today announced that it has entered into securities purchase agreements with certain institutional and accredited investors to purchase shares of common stock, pre-funded warrants and accompanying warrants to purchase shares of common stock. If the warrants to purchase common stock are exercised in full, the private placement would provide approximately $192.5 million in gross proceeds and result in the issuance of approximately 12.2 million shares of common stock. The private placement was priced “at-the-market” under the rules and regulations of The Nasdaq Stock Market LLC. The private placement is expected to close on or about April 4, 2024, subject to customary closing conditions.

Key Points: 
  • If the warrants to purchase common stock are exercised in full, the private placement would provide approximately $192.5 million in gross proceeds and result in the issuance of approximately 12.2 million shares of common stock.
  • The private placement was priced “at-the-market” under the rules and regulations of The Nasdaq Stock Market LLC.
  • The private placement is expected to close on or about April 4, 2024, subject to customary closing conditions.
  • Guggenheim Securities, LLC is acting as sole placement agent for the private placement and is being advised by Mintz, Levin, Cohn, Ferris, Glovsky, and Popeo, P.C.

Surrozen Announces Safety, Pharmacodynamic and Liver Function Data for SZN-043

Retrieved on: 
Monday, April 1, 2024

SOUTH SAN FRANCISCO, Calif., April 01, 2024 (GLOBE NEWSWIRE) -- Surrozen, Inc. (“Surrozen” or the “Company”) (Nasdaq: SRZN), a company pioneering targeted therapeutics that selectively activate the Wnt Pathway for tissue repair and regeneration, today provided an update on the Phase 1a clinical trial of SZN-043 in healthy volunteers and patients with cirrhosis.   The Phase 1a study was completed in February 2024. SZN-043 demonstrated acceptable safety and tolerability in all subjects, with evidence of target engagement, Wnt signal activation and effects on liver function.   The observed safety and pharmacodynamic activity were the basis for the Company’s previous announcement that it planned to initiate enrollment in the Phase 1b study in alcohol-associated hepatitis.

Key Points: 
  • SZN-043 demonstrated acceptable safety and tolerability in all subjects, with evidence of target engagement, Wnt signal activation and effects on liver function.
  • The observed safety and pharmacodynamic activity were the basis for the Company’s previous announcement that it planned to initiate enrollment in the Phase 1b study in alcohol-associated hepatitis.
  • The randomized, placebo-controlled Phase 1a trial enrolled a total of 48 subjects, including 40 healthy volunteers and 8 patients with cirrhosis and a history of liver disease.
  • Cirrhotic patients also showed evidence of liver function effects after treatment with SZN-043 as measured by HepQuant which is a test that measures cholate clearance, a liver specific function that quantifies liver function.

Telomir Pharmaceuticals Announces Collaboration with Argenta to Study Osteoarthritis in Canines

Retrieved on: 
Friday, March 29, 2024

BALTIMORE, March 26, 2024 (GLOBE NEWSWIRE) -- Telomir Pharmaceuticals, Inc. (Nasdaq:TELO) (“Telomir” or the “Company”), a pre-clinical-stage pharmaceutical company focused on the development and commercialization of Telomir-1 as the first novel small molecule to lengthen the DNA’s protective telomere caps in order to potentially address age-related conditions, today announced that Telomir and global animal health research company Argenta have agreed to begin a three to six-months study on the efficacy of Telomir-1 as a treatment for osteoarthritis and other diseases of aging in canines.

Key Points: 
  • The study will evaluate the efficacy of Telomir-1 for mitigating the progression of osteoarthritis based on symptomatic, radiographic, gross pathologic and histopathologic evaluations.
  • In addition, Telomir believes that this study could be used as part of its pre-clinicial program for eventually evaluating Telomir-1 in humans.
  • It is estimated that nearly 18 million canines in the United States are affected by osteoarthritis.
  • “Osteoarthritis is the most common ailment in canines yet there are currently no treatments that combat the disease.