Legislation

• The completed comments form should be sent to
  [email protected]
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  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

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  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
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  162
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  168
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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.

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  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).
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  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.

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  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.

• Often, when scientists do research around a specific societal challenge, they hope their work will help solve that larger problem.
• Yet translating findings into long-lasting, community-driven solutions is much harder than most expect.
• Issues like climate change, renewable energy, public health and migration are complex, making direct solutions challenging to develop and implement.

Defining use-inspired research

• A framework called use-inspired research and engagement, or UIRE, acknowledges this fact.
• In use-inspired research, the potential applications of findings for society shape the directions of exploration.
• Use-inspired research expands on translational research, prioritizing building connections between practitioners and communities.
• In the U.S., the passage of the CHIPS and Science Act in 2022 further codified use-inspired research.

Producing science in partnership

• Together, these teams apply the results and develop products, implement behavior changes, or further inform community decision-making.
• For example, a large hospital, an academic organization and several nonprofits may partner together to explore issues affecting health care accessibility in the region.

• These groups can then collaborate further to develop specific programs, such as educational initiatives and enhanced health care services.
• They can tailor these to the needs of the community they serve.
• Use-inspired research matters because it looks at all the different issues facing a community holistically and keeps them in mind when investigating potential solutions.
• UIRE is not a substitute for basic, foundational research, which explores new questions to fundamentally understand a topic.

Harnessing early-career engagement

• They also focus on making the findings accessible to those outside academia.
• To craft necessary solutions for complex societal problems, institutions will need to continue backing traditional scholars who excel at pure basic research.
• Creating opportunities for the ongoing involvement of young people will seed a vibrant future for use-inspired research and engagement.

Zoey England is currently completing a Use-Inspired Research Science Communications fellowship, funded through a grant from the National Science Foundation. She has also received funding from CTNext. Jennifer Forbey receives funding from the National Science Foundation. Michael Muszynski receives funding from the National Science Foundation. He is affiliated with the Maize Genetics Cooperation.

• Any personal data will be processed in accordance with the requirements of data protection legislation.
• Any queries concerning the processing of personal data by the Central Bank may be directed to [email protected] .
• iii Other reason for the notification could be voluntary notifications, changes of attribution of the nature of the holding (e.g.
• v Applicable in the cases provided for in Regulation 15(b) to (h) of the Regulations (Article 10 (b) to (h) of Directive 2004/109/EC).

• McBurney has a notable history of leading landmark transactions in natural resources, demonstrating his capability to deliver strategic outcomes for his clients.
• Additionally, Gene has extensive investment banking experience throughout the Caribbean and Latin America, with a special emphasis on Colombia.
• Great Eagle Gold is pleased to announce Gary Harbottle as the new CFO, while also expressing gratitude to Martin Bajic for his dedicated service.
• Great Eagle also regrets to announce the resignation of Kate Fehlenberg from the Board of Directors, but she will continue to provide advisory and consulting services to Great Eagle.