Skin

Herbal medicinal product: Eucalypti aetheroleumArray,Array,Array, F: Assessment finalised

Retrieved on: 
Thursday, April 18, 2024

Herbal medicinal product: Eucalypti aetheroleumArray,Array,Array, F: Assessment finalised

Key Points: 


Herbal medicinal product: Eucalypti aetheroleumArray,Array,Array, F: Assessment finalised

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.

Orphan designation: antisense oligonucleotide targeting exon 73 in the COL7A1 gene Treatment of epidermolysis bullosa, 12/10/2017 Withdrawn

Retrieved on: 
Thursday, April 18, 2024

Orphan designation: antisense oligonucleotide targeting exon 73 in the COL7A1 gene Treatment of epidermolysis bullosa, 12/10/2017 Withdrawn

Key Points: 


Orphan designation: antisense oligonucleotide targeting exon 73 in the COL7A1 gene Treatment of epidermolysis bullosa, 12/10/2017 Withdrawn

Orphan designation: Tranilast Prevention of scarring post glaucoma filtration surgery, 27/07/2010 Positive

Retrieved on: 
Thursday, April 18, 2024

Orphan designation: Tranilast Prevention of scarring post glaucoma filtration surgery, 27/07/2010 Positive

Key Points: 


Orphan designation: Tranilast Prevention of scarring post glaucoma filtration surgery, 27/07/2010 Positive

Orphan designation: anti-CD3 mAb (SPV-T3a)-ricin A chain fusion protein,anti-CD7 mAb (WT1)-ricin A chain fusion protein Treatment of graft-versus-host disease, 26/08/2005 Positive

Retrieved on: 
Thursday, April 18, 2024

Orphan designation: anti-CD3 mAb (SPV-T3a)-ricin A chain fusion protein,anti-CD7 mAb (WT1)-ricin A chain fusion protein Treatment of graft-versus-host disease, 26/08/2005 Positive

Key Points: 


Orphan designation: anti-CD3 mAb (SPV-T3a)-ricin A chain fusion protein,anti-CD7 mAb (WT1)-ricin A chain fusion protein Treatment of graft-versus-host disease, 26/08/2005 Positive

Orphan designation: Synthetic hypericin Treatment of cutaneous T-cell lymphoma, 28/07/2015 Positive

Retrieved on: 
Thursday, April 18, 2024

Orphan designation: Synthetic hypericin Treatment of cutaneous T-cell lymphoma, 28/07/2015 Positive

Key Points: 


Orphan designation: Synthetic hypericin Treatment of cutaneous T-cell lymphoma, 28/07/2015 Positive

Orphan designation: Diacerein Treatment of epidermolysis bullosa, 20/02/2014 Positive

Retrieved on: 
Thursday, April 18, 2024

Orphan designation: Diacerein Treatment of epidermolysis bullosa, 20/02/2014 Positive

Key Points: 


Orphan designation: Diacerein Treatment of epidermolysis bullosa, 20/02/2014 Positive

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.

Pubic hair: beyond brazilians, more than manscaping

Retrieved on: 
Wednesday, April 10, 2024

So, what about pubic hair?

Key Points: 
  • So, what about pubic hair?
  • Let’s talk about sex
    Much of the effort that goes into shaping or removing pubic hair also shapes and defines sexual identities.
  • While the properties of pheromones are not as well established in humans, there’s speculation that pubic hair plays a significant role.
  • Pubic hair grooming has been associated with an increased risk of genital infections but this has also been refuted.

Infections after surgery are more likely due to bacteria already on your skin than from microbes in the hospital − new research

Retrieved on: 
Wednesday, April 10, 2024

Genetic data from the bacteria causing these infections – think CSI for E. coli – tells another story: Most health care-associated infections are caused by previously harmless bacteria that patients already had on their bodies before they even entered the hospital.

Key Points: 
  • Genetic data from the bacteria causing these infections – think CSI for E. coli – tells another story: Most health care-associated infections are caused by previously harmless bacteria that patients already had on their bodies before they even entered the hospital.
  • We show that many surgical site infections after spinal surgery are caused by microbes that are already on the patient’s skin.

Surgical infections are a persistent problem

  • Among the different types of heath care-associated infections, surgical site infections stand out as particularly problematic.
  • A 2013 study found that surgical site infections contribute the most to the annual costs of hospital-acquired infections, totaling over 33% of the US$9.8 billion spent annually.
  • Still, surgical site infections occur following about 1 in 30 procedures, typically with no explanation.
  • While rates of many other medical complications have shown steady improvement over time, data from the Agency for Healthcare Research and Quality and the Centers for Disease Control and Prevention show that the problem of surgical site infection is not getting better.

BYOB (Bring your own bacteria)

  • Prior studies on surgical site infection have been limited to a single species of bacteria and used older genetic analysis methods.
  • But new technologies have opened the door to studying all types of bacteria and testing their antibiotic resistance genes simultaneously.
  • Over a one-year period, we sampled the bacteria living in the nose, skin and stool of over 200 patients before surgery.
  • In fact, 86% of the bacteria causing infections after spine surgery were genetically matched to bacteria a patient carried before surgery.
  • That number is remarkably close to estimates from earlier studies using older genetic techniques focused on Staphylococcus aureus.
  • They likely acquired these antibiotic-resistant microbes through prior antibiotic exposure, consumer products or routine community contact.

Preventing surgical infections

  • At face value, our results may seem intuitive – surgical wound infections come from bacteria that hang out around that part of the body.
  • If the most likely source of surgical infection – the patient’s microbiome – is known in advance, this presents medical teams with an opportunity to protect against it prior to a scheduled procedure.
  • The fact that most infections don’t actually start with sources in the hospital is probably a testament to the efficacy of these protocols.


Dustin Long receives funding from the National Institutes of Health. Dr Bryson-Cahn receives funding from the Gordon and Berry Moore Foundation and is the co-medical director for Alaska Airlines.