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

Retrieved on:

星期四, 四月 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
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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).
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.

A new measure of firm-level competition: an application to euro area banks

Retrieved on:

星期四, 四月 18, 2024

Glass, RPD, Journal of Economic Perspectives, Goldberg, Employment, Lead, Competition, SCP, Research Papers in Economics, TCF, Intuition, Laboratory, Euromoney, Bank of Canada, Calendar, International political economy, Manufacturing, Oxford Economic Papers, Harvard University Press, Paper, Linearity, R2, Environment, Delicatessen, System, Website, Panzar, Working paper, World Bank, Elzinga, Friends, Madiga, CPB, Investment, Lerner index, Statistics, Croatian National Bank, PDF, Elsevier, ECB, Industrial organization, Policy, Social science, JEL, Operations research, Internet, Journal, Research, Literature, European Central Bank, Journal of Economic Surveys, MRP, Commercial, Section 5, Financial intermediary, Ministry of Social Affairs, Elasticity, National bank, Government, Developed country, Cell, Tarazi, Wealth, Publishing, Springer Nature, Prudential, Marketing, Law, The Economic Journal, Lerner, L16, Business economics, OECD, International Monetary Fund, Section 4, Database, Section 3, Krieger, EMU, Section 2, Pressure, Central bank, Economics Letters, Bank, Jorgenson, Character, Sparkassen-Finanzgruppe, Life, EDS, American Economic Review, K2, Appendix, Applied economics, CEE, Palgrave Macmillan, Livret A, Bell Labs, GDP, Part, Country, Public policy, De Economist, Management, Publication, Motivation, Cooperative, Reproduction, IMF, Edward Elgar Publishing, Housing, Handbook, G21, Real estate

Abstract

Key Points:

Abstract
This paper extends Boone (2008) by introducing a competition measure at the individual
firm level rather than for an entire market segment.
We apply this extended Boone indicator to individual bank-level competition
in the loan market in the four largest euro area countries and Austria.
Our new measure of firm-level competition enriches and complements
other competition measures and provides a promising starting point for future market
power analyses.
The only measure among non-structural measures that is based on the
concept of competition as a process of rivalry is the Boone (2008) indicator.
We introduce
a new performance measure of competition by extending the Boone indicator to the
individual firm level.
Introduction
The ability to reliably measure competition is valuable to researchers, analysts, and
policymakers, especially antitrust authorities, financial supervisors, and central banks.
One broad
category of indicators often used to measure competition are structural competition
measures, such as static concentration measures, and dynamic measures, e.g., entry and
exit rates.
Out of these measures, the only measure based on the
concept of competition as a process of rivalry is the Boone indicator.
This study introduces a new performance measure of competition by extending the
Boone indicator to the individual firm level.
It thus measures the
increase in profits in percent of one percentage point increase in efficiency, with marginal
costs as measure of efficiency.
We extend the theoretical
underpinning of the measurement of competition for the entire market of Boone (2008) by
a new measure of individual firm-level competition.
A concern of the literature is the gap
between the practical application and the theoretical framework of Boone (2008).
We introduce within the same theoretical
framework a new measure of competition on firm level, the MRP.
Our new
measure significantly augments the antitrust evaluative framework by shedding light on
whether a merger results in a less competitive market.
Our novel indicator focuses on
firms? incentives to enhance their relative efficiency, as manifested in the elasticity
between relative profits and efficiency.
However, an inefficient firm that is foreclosed could be more
competitive than the larger efficient firm that relies on its scale economies.
Our new metric of competition unveils
banks? ability to influence their profitability in the short term by cutting costs relative to
their peers.
The new MRP indicator provides the ability to assess the impact
of individual banks? competitiveness on their interest rate-setting behaviour in loan
markets.
Incorporating this information promises a more refined understanding of the impact and
timing of monetary policy rates changes on the real economy.
Section 3 introduces within the Boone
(2008) theoretical framework our new measure of individual firm-level competition,
including the interpretation of the MRP.
Section 4 provides an application of our new
ECB Working Paper Series No 2925
6

individual firm-level competition measure to the loan market.
The StructureConduct-Performance paradigm (SCP) provides a traditional framework in the field of
industrial organization for analysing competition behaviour in markets.
Concentrated
markets ease the possibilities to collude implicitly or explicitly and therefore concentrated
markets result in higher prices and profits.
For example, a tougher competition
setup may lead to a reallocation of market shares, potentially forcing some firms to exit
the market.
This approach gives firms? strategic behaviour
central stage and focuses on the strategic interaction on prices and quantities, known as
conjectural variation.
Another measure from
this strand of literature is the H-statistic developed by Panzar and Rosse (1987).
The only competition measure from this performance literature where competition is the
outcome from a process of rivalry is the Boone indicator.
A continuous and monotonically increasing relationship exists between
RPD and the level of competition if firms are ranked by decreasing efficiency.
(2013) compare the Boone indicator with the price-cost margin
and conclude that the profit elasticity is a more reliable measure of competition.
The high
elasticity of profits to efficiency unequivocally indicates that the high market shares and
therefore high profits are due to high efficiency.
A firm that quickly passes changes to the input prices is seen as a price
taker with little market power.
Indicators of competition tend to measure different phenomenon and may provide
conflicting messages, as reported for European banking by Carbo et al.
Application 2: Test the ?quiet life? and related market structure hypotheses using the
MRP as competition or market structure measure.
Data
Our application to individual bank-level competition in the euro area loan market uses
balance sheet and income statement data from the Moody?s Analytics BankFocus for the
calendar years 2013-2020.
As such, most publications
on competition in the euro area includes the largest four member states.
Due to these restrictions the database was reduced to an unbalanced panel of up to 1862
banks (depending on the year) from five euro area countries.
Application 1: Measure bank competition using MRP
Looking at the distribution of the MRP for individual banks (Fig.
A similar finding for the four largest euro area countries as a group is
reported in Carbo et al.
Application 2: Test of market structure hypotheses using MRP
Our new measure of individual-bank competition can be used to test market structure
theories.
Euro area banks? market power,
lending channel and stability: the effects of negative policy rates, European Central Bank
Working Paper, 2790 (February).
A
new approach to measuring competition in the loan markets of the euro area, Applied
Economics, 43 (23), 3155?3167.
Impact of bank competition on the interest rate pass-through in the euro area, Applied
Economics, 45 (11), 1359?1380.

Meyer Burger offers balcony solar system “Made in Germany” and launches sales via its own online store

Retrieved on:

星期三, 四月 10, 2024

Partnership, Electricity, Marketing, Eye, Lead, Meyer Burger, PFAS, Renewable energy

Private customers have the option to customize their balcony solar system online and place their orders directly through meyerburger.com.

Key Points:

Private customers have the option to customize their balcony solar system online and place their orders directly through meyerburger.com.
“Meyer Burger Balcony” gives homeowners as well as tenants the opportunity to generate environmentally friendly solar power directly from their own balcony.
“Meyer Burger Balcony” is available as a complete set with one or two solar modules, including an inverter and optionally with a balcony mounting system from Wagner Solar, also made in Germany.
Further information on the individual components, prices and how to order “Meyer Burger Balcony” can be found at in the online store at https://www.meyerburger.com/balcony.

EQS-News: Aurubis employer brand: Employees are our “most valuable element”

Retrieved on:

星期三, 四月 10, 2024

Roland Harings: “Aurubis is a very appealing employer, as strikingly demonstrated by the strong arguments and images of our employees”

Key Points:

Roland Harings: “Aurubis is a very appealing employer, as strikingly demonstrated by the strong arguments and images of our employees”
Hamburg, March 21, 2024 — Copper, gold, silver, platinum — Aurubis stands for valuable metals.
With “You are our most valuable element”, the company emphasizes the essential importance of the employees and places them at the center of its new employer brand.
We are very appealing as an employer and are growing internationally with our Driving Sustainable Growth strategy, offering very attractive jobs.
It shows the diversity of Aurubis employees in a broad variety of work environments within the multimetal company.

Peak Performance Coaching and Consulting LLC Launches Boutique Coaching Practice to Empower Leaders and Businesses

Retrieved on:

星期一, 三月 18, 2024

Dream, Organization, Small business, Lead, Consultant, Growth, Management

Glen Allen, Virginia--(Newsfile Corp. - March 18, 2024) - Peak Performance Coaching and Consulting LLC announces the launch of its boutique coaching practice aimed at revolutionizing leadership development, career coaching, and small business consulting.

Key Points:

Glen Allen, Virginia--(Newsfile Corp. - March 18, 2024) - Peak Performance Coaching and Consulting LLC announces the launch of its boutique coaching practice aimed at revolutionizing leadership development, career coaching, and small business consulting.
With Peak Performance Coaching and Consulting LLC, I aim to empower individuals and businesses to navigate these challenges with confidence and achieve their highest aspirations."
Peak Performance Coaching and Consulting LLC offers a range of services tailored to meet the unique needs of clients, including:
Executive Peak Performance Coaching Program : Designed to help executives overcome their inner critic, lead with confidence, and achieve personal and organizational success.
For more information about Peak Performance Coaching and Consulting LLC and its services, please visit www.brianwhitecoaching.com and www.smallbiz.brianwhitecoaching.com .

Chu Kong Shipping Announces 2023 Annual Results, Profit Attributable to Equity Holders of the Company Increases by 22.0% year on year to HK$114.1 Million

Retrieved on:

星期一, 三月 25, 2024

During the Year, the Group's terminal navigation logistics business progressed well, with continuous improvement in the cargoes transportation volume.

Key Points:

During the Year, the Group's terminal navigation logistics business progressed well, with continuous improvement in the cargoes transportation volume.
Profit for the Year increased by 13.5% year-on-year to HK$122.6 million (2022: HK$108.0 million), while profit attributable to equity holders of the Company amounted to HK$114.1 million (2022: HK$93.5 million), representing an increase of 22.0% as compared to the same period last year.
The volume of break bulk cargoes transportation for the Year was 1,143,000 tons, representing a year-on-year significant increase of 68.6%.
CKTL has also successfully won the bid for a sand supply for certain phases of the Hong Kong International Airport construction project.

China Lilang Announces 2023 Annual Results

Retrieved on:

星期一, 三月 18, 2024

Consumption, Growth, Lead, Clothing, Policy, City, Central government, HK36, Collection, Marketing, Retail

HONG KONG, Mar 18, 2024 - (ACN Newswire) - China Lilang Limited ("China Lilang" or the "Company", together with its subsidiaries, the "Group"; stock code: 1234) today announced its 2023 annual results.

Key Points:

HONG KONG, Mar 18, 2024 - (ACN Newswire) - China Lilang Limited ("China Lilang" or the "Company", together with its subsidiaries, the "Group"; stock code: 1234) today announced its 2023 annual results.
Mr. Wang Dong Xing, Chairman and Non-Executive Director of China Lilang, said:
"In 2023, China welcomed its first year of recovery after three years of pandemic.
For the year ended 31 December 2023, the Group's revenue increased by 14.8% year-on-year to RMB3.544 billion.
The distributors of the core collection had to digest the inventory from 2022, which suppressed the order growth in 2023.

Gatos Silver Reports Q1 2024 Production Results at Top End of Guidance

Retrieved on:

星期三, 四月 10, 2024

Silver, Zinc, Gold, Lead, Mining, Printed circuit board

For 2023, silver equivalent production was calculated using prices of $22/oz silver, $1.20/lb zinc, $0.90/lb lead and $1,700/oz gold.

Key Points:

For 2023, silver equivalent production was calculated using prices of $22/oz silver, $1.20/lb zinc, $0.90/lb lead and $1,700/oz gold.
For comparative purposes, the calculated silver equivalent production for the three months ended March 31, 2023 would be 3.64 million ounces using price assumptions for 2024.
Silver equivalent1 production for the first quarter of 2024 was 3.70 million ounces, similar to the first quarter of 2023 and tracking to the top end of the previously disclosed 2024 guidance range of 13.5 million ounces to 15.0 million ounces.
Silver production in the first quarter of 2024 was 2.37 million ounces, 2% lower than the first quarter of 2023.

Zymeworks Presents New Data from Multiple Preclinical Development Programs at 2024 American Association for Cancer Research Annual Meeting

Retrieved on:

星期一, 四月 8, 2024

The compelling preclinical activity profile supports ZW191 development across multiple tumor types, including FRα-high/mid/low ovarian cancers and other FRα-expressing indications, including non-small cell lung cancer, endometrial cancer, and triple-negative breast cancer.

Key Points:

The compelling preclinical activity profile supports ZW191 development across multiple tumor types, including FRα-high/mid/low ovarian cancers and other FRα-expressing indications, including non-small cell lung cancer, endometrial cancer, and triple-negative breast cancer.
An investigational new drug (IND) submission or foreign equivalent is planned for 2024.
Small cell lung cancer (SCLC) is an aggressive neuroendocrine cancer with a poor prognosis and high unmet medical need2.
Displays no cross-linking of T cells and exhibits obligate cis T cell binding of CD28, requiring co-engagement of CD3.

Fortuna reports strong gold equivalent production of 112,543 ounces in the first quarter of 2024

Retrieved on:

星期一, 四月 8, 2024

Silver, FVI, PB, FSM, Zinc, Gold, Lead, News, NSR, TSX, AG, Printed circuit board

VANCOUVER, British Columbia, April 08, 2024 (GLOBE NEWSWIRE) -- Fortuna Silver Mines Inc. (NYSE: FSM) (TSX: FVI) reports strong gold and gold equivalent production for the first quarter of 2024 from its five operating mines in West Africa and Latin America.

Key Points:

VANCOUVER, British Columbia, April 08, 2024 (GLOBE NEWSWIRE) -- Fortuna Silver Mines Inc. (NYSE: FSM) (TSX: FVI) reports strong gold and gold equivalent production for the first quarter of 2024 from its five operating mines in West Africa and Latin America.
Gold and silver production for the quarter was 89,678 ounces and 1.1 million ounces, respectively, or 112,543 gold equivalent ounces1, including lead and zinc by-products.
Fortuna reiterates its 2024 annual production guidance range of 343 to 385 thousand ounces of gold and 4.0 to 4.7 million ounces of silver or between 457 and 497 thousand ounces of gold equivalent ounces2, including lead and zinc by-products (refer to Fortuna news release dated January 18, 2024 ).
Gold equivalent production of 112,543 ounces; a 20 percent increase compared to Q1 2023 (94,110 oz Au Eq)4 and a 17 percent decrease compared to Q4 2023 (136,154 oz Au Eq)3.