Human

Billions of cicadas are about to emerge from underground in a rare double-brood convergence

Retrieved on: 
Thursday, April 18, 2024

From late April through June 2024, the largest brood of 13-year cicadas, known as Brood XIX, will co-emerge with a midwestern brood of 17-year cicadas, Brood XIII.

Key Points: 
  • From late April through June 2024, the largest brood of 13-year cicadas, known as Brood XIX, will co-emerge with a midwestern brood of 17-year cicadas, Brood XIII.
  • A co-emergence like this of two specific broods with different life cycles happens only once every 221 years.
  • For about four weeks, scattered wooded and suburban areas will ring with cicadas’ distinctive whistling, buzzing and chirping mating calls.
  • Once the eggs hatch, new cicada nymphs will fall from the trees and burrow back underground, starting the cycle again.
  • It’s no accident that the scientific name for periodical 13- and 17-year cicadas is Magicicada, shortened from “magic cicada.”

Ancient visitors

  • Molecular analysis has shown that about 4 million years ago, the ancestor of the current Magicicada species split into two lineages.
  • The resulting three lineages are the basis of the modern periodical cicada species groups, Decim, Cassini and Decula.
  • The sudden appearance of so many insects reminded them of biblical plagues of locusts, which are a type of grasshopper.
  • During the 19th century, notable entomologists such as Benjamin Walsh, C.V. Riley and Charles Marlatt worked out the astonishing biology of periodical cicadas.

Acting in unison

  • This increases their chances of accomplishing their key mission aboveground: finding mates.
  • While periodical cicadas largely come out on schedule every 17 or 13 years, often a small group emerges four years early or late.
  • Early-emerging cicadas may be faster-growing individuals that had access to abundant food, and the laggards may be individuals that subsisted with less.

Will climate change shift Magicicada clocks?

  • As glaciers retreated from what is now the U.S. some 10,000 to 20,000 years ago, periodical cicadas filled eastern forests.
  • Today there are 12 broods of 17-year periodical cicadas in northeastern deciduous forests, where trees drop leaves in winter.
  • Because periodical cicadas are sensitive to climate, the patterns of their broods and species reflect climatic shifts.
  • Although periodical cicadas prefer forest edges and thrive in suburban areas, they cannot survive deforestation or reproduce successfully in areas without trees.
  • In the late 19th century, one Brood (XXI) disappeared from north Florida and Georgia.
  • Climate change could also have farther-reaching effects.
  • As the U.S. climate warms, longer growing seasons may provide a larger food supply.
  • This may eventually change more 17-year cicadas into 13-year cicadas, just as past warming altered Magicicada neotredecim.
  • We hypothesize that this was due to climate warming.


John Cooley receives funding from the National Science Foundation and the National Geographic Society. Chris Simon has received funding from the National Science Foundation, the Fulbright Foundation, the National Geographic Society and the New Zealand Marsden Fund.

The tragedy of sudden unexpected infant deaths – and how bedsharing, maternal smoking and stomach sleeping all contribute

Retrieved on: 
Thursday, April 18, 2024

Sudden unexpected infant death, or SUID, occurs in infants less than 1 year old who die suddenly and unexpectedly without an obvious cause before investigation, accounting for about 3,400 deaths annually in the U.S..

Key Points: 
  • Sudden unexpected infant death, or SUID, occurs in infants less than 1 year old who die suddenly and unexpectedly without an obvious cause before investigation, accounting for about 3,400 deaths annually in the U.S..
  • These infants die from sudden infant death syndrome, or SIDS, accidental suffocation and strangulation in bed, or other ill-defined and unknown causes.
  • Compared with nonsharing infants in our study, bedsharing infants were more likely to have the following characteristics:


Among nonsharing infants in the study, only one-third were sleeping in the recommended back position, and three-quarters were in sleep areas that had soft bedding such as pillows, comforters or bumper pads at the time of death. Three-quarters of all the sudden unexpected infant deaths in our study were affected by multiple unsafe sleep factors.

Why it matters

  • Rates of sudden unexpected infant deaths overall in the U.S. have changed only minimally in the past 20 years, but racial-ethnic disparities [in these deaths are widening] due to increasing rates among non-Hispanic Black infants.
  • Our study suggests that the majority of these deaths are preventable by following the guidelines for safe infant sleep as outlined by the American Academy of Pediatrics and the National Institute of Child Health and Human Development.
  • Even with knowledge of the recommended practices, many parents find it difficult to follow the recommendations.
  • Others may choose not to follow them or may not follow them all of the time.
  • Bedsharing may also be a common cultural or preferred practice, so not doing so might go against one’s beliefs or preferences.

What’s next

  • Much more research is needed to find the most effective ways to teach families about safe infant sleep.
  • There are currently a number of studies underway using innovative methods to engage and educate parents, starting in pregnancy and continuing after the baby is born.


Fern R. Hauck receives funding from NIH. She is affiliated with American Academy of Pediatrics Task Force on SIDS.

Understanding AI outputs: study shows pro-western cultural bias in the way AI decisions are explained

Retrieved on: 
Thursday, April 18, 2024

If you were affected, you might want an explanation of why an AI system produced the decision it did.

Key Points: 
  • If you were affected, you might want an explanation of why an AI system produced the decision it did.
  • Yet AI systems are often so computationally complex that not even their designers fully know how the decisions were produced.
  • Explainable AI systems help AI engineers to monitor and correct their models’ processing.
  • We wanted to see to what extent researchers indicated awareness of cultural variations that were potentially relevant for designing satisfactory explainable AI.

Cultural differences in explanations

  • The other is externalist, citing factors like social norms, rules, or other factors that are outside the person.
  • However, such explanations are not obviously preferred over externalist explanations in “collectivist” societies, such as those commonly found across Africa or south Asia, where people often view themselves as interdependent.
  • If people from different cultures prefer different kinds of explanations, this matters for designing inclusive systems of explainable AI.
  • Our research, however, suggests that XAI developers are not sensitive to potential cultural differences in explanation preferences.

Overlooking cultural differences

  • Moreover, when we checked the cultural background of the people tested in the studies, we found 48.1% of the studies did not report on cultural background at all.
  • This suggests that researchers did not consider cultural background to be a factor that could influence the generalisability of results.
  • Of those that did report on cultural background, 81.3% only sampled western, industrialised, educated, rich and democratic populations.
  • Yet, out of the studies that reported on cultural background, 70.1% extended their conclusions beyond the study population – to users, people, humans in general – and most studies did not contain evidence of reflection on cultural similarity.

Why the results matter

  • To address this cultural bias in XAI, developers and psychologists should collaborate to test for relevant cultural differences.
  • As AI is being used worldwide to make important decisions, systems must provide explanations that people from different cultures find acceptable.
  • As it stands, large populations who could benefit from the potential of explainable AI risk being overlooked in XAI research.


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.

Gaza update: the questionable precision and ethics of Israel’s AI warfare machine

Retrieved on: 
Thursday, April 18, 2024

The IDF says it has been working on information gleaned from questioning Palestinian fighters captured in the fighting.

Key Points: 
  • The IDF says it has been working on information gleaned from questioning Palestinian fighters captured in the fighting.
  • According to a report in the Jerusalem Post on April 17, the Palestinian fighters were hiding out in schools in the area.
  • The investigation, by online Israeli magazines +927 and Local Call examined the use of an AI programme called “Lavender”.
  • It’s important to note that the IDF is not the only military to be working with AI in this way.
  • But one function of the way the IDF is harnessing Lavender in this current conflict is its use alongside other systems.
  • Read more:
    Israel accused of using AI to target thousands in Gaza, as killer algorithms outpace international law

The Iranian dimension

  • Away from the charnel house that is the Gaza Strip, the focus has been on the aftermath of Israel’s strike on the Iranian embassy in Baghdad on April 1.
  • As is his wont, Iran’s supreme leader, Ayatollah Ali Khamenei, vowed revenge, declaring: “The Zionist regime will be punished by the hands of our brave men.
  • And this was very much how it was to turn out when Iran’s drones and missiles flew last weekend.
  • Read more:
    Could Israel's strike against the Iranian embassy in Damascus escalate into a wider regional war?
  • Read more:
    Why Iran's failed attack on Israel may well turn out to be a strategic success

The nuclear option?


One of the possibilities being widely canvassed is that Israel could mount some kind of attack on Iran’s nuclear weapons programme. This has been revitalised in the years since Donald Trump pulled the US out of the deal negotiated by his predecessor Barack Obama.

  • He walks us through the history of Iran’s nuclear programme, a story littered with the bodies of Iranian nuclear scientists and the wreckage of its nuclear facilities thanks to fiendish cyberattacks such as the Stuxnet virus developed by Israel and the US that was launched against Iran in 2010.
  • Since Trump quit the nuclear deal, Iran has gone full-steam ahead in ramping up its nuclear weapons programme, while reportedly hiding its key installations in deep underground bunkers that are thought impossible to destroy from the air.

Things that go buzz in the night – our global study found there really are more insects out after dark

Retrieved on: 
Thursday, April 18, 2024

We searched for meaningful comparisons of insect activity by day and by night.

Key Points: 
  • We searched for meaningful comparisons of insect activity by day and by night.
  • Our global analysis confirms there are indeed more insects out at night than during the day, on average.
  • And now we know for sure, we can make more strident efforts to conserve insects and preserve their vital place in the natural world.

Building a global dataset of sleepless nights

  • We narrowed these down to studies using methods that would not influence the results.
  • For instance, we excluded studies that collected insects by using sweep nets or beating branches, as these methods can capture resting insects along with active ones.
  • These include pitfall traps (for crawling insects), flight interception traps (for flying insects) and aquatic drift nets (for swimming insects).


Eventually, we honed in on 99 studies published between 1959 and 2022. These studies spanned all continents except Antarctica and encompassed a wide range of habitats on both land and water.

What did we find?


We found more mayflies, caddisflies, moths and earwigs at night. On the other hand, there were more thrips, bees, wasps and ants during the day.

  • In these aquatic areas, there could be twice as many insects active during the night.
  • In contrast, land-based insects were generally more active during the day, especially in grasslands and savannas.
  • We also found insects were more active at night in warmer parts of the globe, where there are higher maximum temperatures.

Findings underscore the threats to nocturnal insects


Insects perform many vital “ecosystem services” such as pollination, nutrient cycling and pest control. Many of these services may be provided at night, when more insects are active. This means we need to curtail some of our own activities to support theirs. For instance, artificial lighting is detrimental to nocturnal insects.

  • In the hottest regions of the globe such as the tropics, the warming trend may further reduce the activity of nocturnal insects that struggle to cope with heat.
  • Read more:
    Insects will struggle to keep pace with global temperature rise – which could be bad news for humans


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.

It is industry, not government, that is getting in the way of a ‘just transition’ for oil and gas workers

Retrieved on: 
Thursday, April 18, 2024

Canada’s oil and gas sector is in the throes of profound change driven by shifting consumer demand and global commitments to dramatically lower greenhouse gas (GHG) emissions.

Key Points: 
  • Canada’s oil and gas sector is in the throes of profound change driven by shifting consumer demand and global commitments to dramatically lower greenhouse gas (GHG) emissions.
  • But are industry and politicians sincere in their affection for oil and gas workers?
  • Or, are energy workers merely a convenient vehicle to shield the industry from change that many Canadians believe is inevitable?

Picket lines

  • We found the company used expanding pipeline capacity and Canada’s emission reduction policies to justify its push to force workers to take concessions.
  • The lockout came to an end in June 2020 when Local 594 members ratified an agreement with FCL.

“Just” transition?

  • Just this month federal Conservatives, conservative provincial governments and protesters came out strong against the increase to the Trudeau government’s signature climate policy — the price on carbon.
  • The Liberal government has faced significant backlash against its other climate policies as well, including the oil and gas emissions cap.
  • Conservatives position themselves as the voice of fossil fuel workers, who they cast as victims of carbon pricing and other federal environmental policies.
  • Shuttered factories and their laid-off employees are victims of Liberal anti-oil policies, industry proponents insist.

Questions unanswered

  • Time and again governments, local police and courts advanced the interests of industry over those of unionized workers.
  • Or, will the inevitable winding down of extractive fossil fuel industries lead to acrimonious labour relations and social injustice?
  • The path designed by powerful oil and gas interests is not one that puts workers or communities first.
  • Emily Eaton receives funding from the Social Sciences and Humanities Research Council of Canada.
  • Andrew Stevens receives funding from the Social Sciences and Humanities Research Council and the University of Regina (U of R fund: Unifor Scholar in Labour Relations).

Orphan designation: Recombinant adeno-associated viral vector serotype S3 containing codon-optimised expression cassette encoding human coagulation factor IX variant Treatment of haemophilia B, 26/10/2018 Withdrawn

Retrieved on: 
Thursday, April 18, 2024

Orphan designation: Recombinant adeno-associated viral vector serotype S3 containing codon-optimised expression cassette encoding human coagulation factor IX variant Treatment of haemophilia B, 26/10/2018 Withdrawn

Key Points: 


Orphan designation: Recombinant adeno-associated viral vector serotype S3 containing codon-optimised expression cassette encoding human coagulation factor IX variant Treatment of haemophilia B, 26/10/2018 Withdrawn

EMA/FVE info session on restrictions for the use of certain antimicrobials in animals, Online, European Medicines Agency, Amsterdam, the Netherlands, from 23 May 2024, 15:00 (CEST) to 23 May 2024, 16:00 (CEST)

Retrieved on: 
Thursday, April 18, 2024

During this session, participants will have the opportunity to engage with experts who contributed to the development of the available guidance.

Key Points: 
  • During this session, participants will have the opportunity to engage with experts who contributed to the development of the available guidance.
  • Registration
    Please register for the webinar using the below online form:
    EMA/FVE info session on restrictions for the use of certain antimicrobials in animals
    Please note this event will be recorded and published on the EMA website.
  • By registering for this event, you are consenting to EMA to process your personal data in accordance with Regulation (EU) 2018/1725.
  • EMA's data protection notice below explains how personal data is processed by the Agency and via the tool Webex:

Draft revised Heads of Medicines Agency / European Medicines Agency guidance document on the identification of personal data and commercially confidential information within the structure of the marketing authorisation application dossier

Retrieved on: 
Thursday, April 18, 2024
Steps, Union, Patient, CTD, Syndrome, CCI, Local, Disclosure, Toxicity, Process validation, MAH, Clinical trial, IP, RMP, Pharmacovigilance, Cell, Legislation, Annex, Trial of the century, Escherichia coli, Safety, Pediatrics, INTRODUCTION, Documentation, Prevalence, Vital signs, Tablet, Design, Transparency, Conclusion, Pip, Analysis, European Parliament, INN, Record, Quality, Generic, Biology, CMO, Genotoxicity, Composition, CTIS, Uncontrolled, Health care, European Medicines Agency, Prejudice, Committee, Policy, HCP, Animal, Characterization, Cell bank, Fertility, IRB, CMOS, Risk management, Private law, European Pharmacopoeia, Telephone, Research, Good, Data Protection Directive, Ampere-hour, IEC, QP, Human, Personal data, Labelling, Bibliography, Figure, MAA, R4, Institutional review board, Elucidation, Marketing, M4, ChromeOS, Contract research organization, Mental, Impairment, Toxicokinetics, NCA, Independent, Metabolite, Drug, Risk, Metabolism, GMO, Organ, EMA, Common Technical Document, General Data Protection Regulation, Confidentiality, PPD, PI, Language, DRUG, Privacy, Result, Claimed, Medication, Comparison, Ethics, Drive, PD, Narrative, EEA, Developmental toxicity, Saccharomyces cerevisiae, Pharmacopoeia, PIP, MCB, HMA, Physical chemistry, Midol, Particle size, Council, GCP, European Economic Area, Draft, Fermentation, Overview, Justification, Control, Dicarboxylic acid, Pharmacology, WCB, Expert, Immunogenicity, Data, Study, Publication, European, ICH, Element, Analytical procedures (finance auditing), Name, Common, Guideline, Exceptional circumstances, ID, Liver, Chin Na, Toxicology, Protein primary structure, Immunosuppressive drug, Vaccine

See websites for contact details

Key Points: 
    • See websites for contact details
      Heads of Medicines Agencies www.hma.eu
      European Medicines Agency www.ema.europa.eu

      11

      Table of contents

      12

      Abbreviations .............................................................................................. 3

      13

      Definitions ................................................................................................... 4

      14

      1.

    • redaction, masking,

      68

      hiding) in such a manner that the recipient can no longer attribute the resulting information to a data

      69

      subject and make it identifiable.

    • 81

      Contract Manufacturing Organisation (CMO): shall mean an arrangement under which a

      82

      manufacturer provides upstream manufacturing services under contract on behalf of third-party

      83

      pharmaceutical companies.

    • 94

      Protected Personal Data (PPD): shall mean any personal data which should be protected from

      95

      disclosure.

    • ?Finalised? shall mean that the marketing

      102

      authorisation (MA) has been granted or refused or that the MAA has been withdrawn.

    • The application of the general principles laid down in this guidance is without prejudice to

      106

      national rules on transparency.

    • The guidance should be read in conjunction with the relevant applicable

      107

      legislation and case law on transparency and data protection.

    • 117

      This guidance document is intended to apply to information/documents on medicinal products for

      118

      human use, for which the procedure has been finalised under the national, mutual recognition,

      119

      decentralised and centralised procedures.

    • Third

      124

      parties shall be informed or consulted as needed depending on respective national and European legal

      125

      frameworks.

    • 140

      In the following sections, the agreed principles on PD and CCI are presented, including guidance on

      141

      whether such information can be disclosed.

    • EMA/131365/2024

      Page 5/50

      142

      Any information identified as PD or CCI must be subject to a preliminary review by the EMA/NCA prior

      143

      to the possible disclosure of the information/documents.

    • Principles on the protection of personal data (PD)

      145

      The protection of PD is enshrined in EU legislation; it is a fundamental right of EU citizens.

    • In

      146

      compliance with the applicable European/national legislation, PD should be anonymised in order to

      147

      avoid the disclosure of the document undermining the privacy and integrity of any individual.

    • EMA/NCA applies a risk-based approach to assess which PD elements are to be

      152

      removed from the information/documents in order to limit the risk of re-identification.

    • are included in the MAA dossier because they have a legally

      164

      defined role or responsibility and it is in the public interest to disclose this data.

    • 168

      Applicants are advised that non-essential information (e.g., personal address, personal phone number)

      169

      should not be included in the MAA dossier.

    • The

      183

      confidentiality of records that could identify subjects should be protected, respecting the privacy and

      184

      confidentiality rules in accordance with the applicable regulatory requirement(s).

    • 185

      The applicant remains responsible for compliance with the relevant legislation in cases where such data

      186

      is inadvertently included in the MAA dossier.

    • 188

      EMA/NCA applies a risk-based approach to assess which personal data elements need to be removed

      189

      from the information/documents in order to limit the risk of re-identification.

    • 194

      EMA/NCA applies a risk-based approach to assess which personal data elements need to be removed

      195

      from the information/documents in order to limit the risk of re-identification.

    • 205

      Any proposal to consider information as commercially confidential should be properly justified by the

      206

      owner of the information.

    • In this respect, any reference(s) to the risk of that interest being

      209

      undermined should be foreseeable and not purely hypothetical.

    • 210

      Information that is already in the public domain is not considered to be commercially confidential.

    • Information on the Quality and Manufacturing of medicines

      226

      A general principle regarding quality and manufacturing information is that detailed information could

      227

      be considered commercially confidential but general information should be disclosed.

    • 234

      In general, and if not in the public domain, the names of manufacturers or suppliers of the active

      235

      substance or the excipients are considered commercially confidential.

    • 248

      A general description of the type of test methods used and the appropriateness of the specification is

      249

      not commercially confidential.

    • General information on the fermentation and purification process

      259

      is not commercially confidential, although details including operating parameters and specific material

      260

      requirements are commercially confidential.

    • 273

      A general description of the type of test methods used and the appropriateness of the specification is

      274

      not commercially confidential.

    • In general, the data included in clinical trial study reports is considered to be data that can be

      283

      disclosed once PD has been anonymised.

    • 338

      In each module, a non-exhaustive list of information that may be considered protected personal data (PPD) or commercially confidential information

      332
      333

      339

      (CCI) is included.

    • ?

      Direct contact details such as telephone

      Therefore, please refer to the appropriate sub-

      number, fax number, email, postal address,

      modules hereafter for guidance.

    • ?

      Information that may reveal strategic
      (contractual) agreements

      ?

      Any quality information on the clinical batches

      principal investigator

      that might be included here (such as e.g.

    • ?

      Information that may reveal strategic
      (contractual) agreements

      principal investigator

      Study Reports
      5.3.3.3

      as the evaluation of new formulation, innovative

      number, fax number, email, postal

      Paediatric Development Plan (PIP), etc.

    • This may include taking into

      More Than One Study
      5.3.5.4

      Other Clinical Study Reports

      5.3.6

      Reports of Post-Marketing
      Experience

      5.3.7

      Direct identifiers such as name,
      signature, contact details, etc.

Draft template for assessment report for the development of European herbal monographs and European Union list entries - Revision 6

Retrieved on: 
Thursday, April 18, 2024

The completed comments form should be sent to

Key Points: 
    • The completed comments form should be sent to
      [email protected]
      10
      11
      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

      Assessment report on
      EMA/HMPC/418902/2005

      Page 4/41

      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
      144
      145

      150
      151
      152
      153
      154

      162
      163
      164
      165
      166
      167
      168
      169
      170
      171
      172
      173
      174
      175

      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.

    • Assessment report on
      EMA/HMPC/418902/2005

      Page 6/41

      176
      177
      178
      179
      180
      181
      182
      183
      184
      185
      186
      187
      188
      189
      190
      191
      192

      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).
    • Assessment report on
      EMA/HMPC/418902/2005

      Page 8/41

      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.

    • Assessment report on
      EMA/HMPC/418902/2005

      Page 10/41

      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.