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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
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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.

Template for a European Union herbal monograph

Retrieved on:

Thursday, April 18, 2024

Key Points:

Draft guideline on good agricultural and collection practice (GACP) for starting materials of herbal origin - Revision 1

Retrieved on:

Thursday, April 18, 2024

Reproduction, SCOPE, Eating, Pesticide, Convention, Change control, Confusion, Alkaloid, Climate, Fungus, Directive (European Union), Ethylene oxide, Wind, Wood, Glass, European Medicines Agency, HMPS, QDG, Hygiene, Water, Marketing, Fertilizer, Legislation, Manure, Distillation, Risk, Education, Committee, Compost, Draft, Policy, Person, EMA, Seed, Polycyclic aromatic hydrocarbon, Collection, Freezing, GMP, Risk assessment, GACP, Sunlight, Fermentation, Personal protective equipment, Animal, Herbal, Herbicide, Weather, INTRODUCTION, Documentation, Regeneration, Decontamination, EudraLex, Disease, International trade, European Pharmacopoeia, Part, Livestock, Public, Inhalation, Knowledge, Seedling, Factorization of polynomials, Record, Plant, Skin, API, Irrigation, Part Two, Soil, Directive, Pharmacopoeia, Codex, Guideline, Temperature, Attention, Hydrocarbon, Pyrrolizidine alkaloid, Polychlorinated biphenyl, Growth, Rotation, Incineration, Environment, Humidity, Smell, Ventilation, Light, Bird, Mineral, Fumigation, Pyrrolizidine, SOP, Housing, Smoking, Atmosphere, Postharvest, Rain, Liver, QWP, Medicinal plants

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

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30

EXECUTIVE SUMMARY

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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

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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
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185

7.
Where possible, stable varieties and cultivars naturally
Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
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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
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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

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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
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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

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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

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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 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.

Luis de Guindos: Presentation of the ECB Annual Report 2023 to the Committee on Economic and Monetary Affairs of the European Parliament

Retrieved on:

Thursday, April 18, 2024

Stock market development and familiarity (language and distance) are considered key determinants for home bias.

Key Points:

Stock market development and familiarity (language and distance) are considered key determinants for home bias.
The literature neglects however that investors often invest in foreign funds domiciled in financial centers.

Survey on credit terms and conditions in euro-denominated securities financing and OTC derivatives markets (SESFOD) - March 2024

Retrieved on:

Thursday, April 18, 2024

Survey on credit terms and

Key Points:

Survey on credit terms and
conditions in euro-denominated
securities financing and OTC
derivatives markets (SESFOD)
March 2024
The Eurosystem conducts a three-monthly qualitative survey on credit terms and
conditions in euro-denominated securities financing and over-the-counter (OTC)
derivatives markets.
The survey questions are grouped into three sections:
1.
counterparty types ? credit terms and conditions for various counterparty
types in both securities financing and OTC derivatives markets;

2.

securities financing ? financing conditions for various collateral types;

3.

non-centrally cleared OTC derivatives ? credit terms and conditions for
various derivative types.
The survey focuses on euro-denominated instruments in securities financing and
OTC derivatives markets.
For securities financing, the survey refers to the
euro-denominated securities against which financing is provided, rather than the
currency of the loan.
Reporting institutions should report on their global credit terms, so the survey is
aimed at senior credit officers responsible for maintaining an overview of the
management of credit risks.
SESFOD March 2024
2

March 2024 SESFOD results
(Review period from December 2023 to February 2024)
The March 2024 Survey on credit terms and conditions in euro-denominated
securities financing and OTC derivatives markets (SESFOD) reports qualitative
changes in credit terms between December 2023 and February 2024.
Looking at credit terms and conditions for the various types of non-centrally cleared
OTC derivative, initial margin requirements increased slightly for all derivative types.
Survey respondents reported mostly unchanged conditions as regards the maximum
amount of exposure and the maximum maturity of trades.
Moreover, they reported that the volume of valuation disputes had
declined for all derivative types except credit derivatives.
The survey asked respondents to compare credit terms
and conditions on the cut-off date for the March 2024 survey round (i.e.
Compared with the
previous year, overall terms and conditions for securities financing and OTC
derivatives transactions had eased somewhat across all counterparties, while credit
standards for funding secured against various types of collateral and non-price terms
in OTC derivatives markets were generally tighter.
Credit terms and conditions for various counterparty types in both
securities financing and OTC derivatives markets
Overall credit terms and conditions eased between December 2023 and
February 2024 (Chart A).
The overall easing of conditions masked some
heterogeneity between price and non-price terms, and across different types of
counterparty, though reported changes were relatively small.
Credit terms and conditions for various types of non-centrally
cleared OTC derivative
Initial margin requirements increased slightly for all derivative types.
Meanwhile, they reported
unchanged conditions for credit derivatives referencing sovereigns and commodities,
as well as a slight deterioration for credit derivatives referencing corporates and
structured credit products.
The survey asked respondents to compare the credit terms and conditions observed
on the cut-off date for the March 2024 survey (i.e.
Compared with the previous year, overall terms and conditions for securities
financing and OTC derivatives transactions had eased somewhat across all
counterparties.
Survey respondents reported that non-price credit terms in OTC derivatives
markets had tightened somewhat for almost all types of derivative relative to
the previous year.

Central bank digital currency and monetary policy implementation

Retrieved on:

Thursday, April 18, 2024

E41, Central bank digital currency, Atlantic Council, Research Papers in Economics, Remuneration, Norges Bank, People's Bank of China, Policy, Central Bank of Myanmar, Bank for International Settlements, Blog, Financial innovation, Sveriges Riksbank, Bank of Canada, Mechanics, Journal of Monetary Economics, Insurance, Bank of England, E42, Corridor, Quarterly Journal of Economics, Report card, Frankfurt, Appetite, American Economic Association, Digital rupee, Rosolin, RBI, PDF, Private, ECB, Committee, Inden, North Rhine-Westphalia, Bank, Canadian International Council, Social science, JEL, JMD, ECCB, Digital, Journal, Research, POC, European Central Bank, ENaira, M.A, Monetary economics, Section 5, Government, ISSN, The, Central bank, Finance, Buffer, Parliament, CBN, EONIA, Asset, ATM, Risk, International Monetary Fund, Interbank, Section 4, Ministry, Press release, Section 3, Human, Waterfall, Cryptocurrency, Economy, Swiss National Bank, PIB, Section 2, Conference, Reserve Bank, Reserve Bank of India, GBP, Progress, Road, American Economic Review, CBB, Digital currency, Agur, European Commission, International Settlement, Constraint, Money, Community business development corporation, City, Equivalence, Eligibility, Ministry of Finance, Report, Control, Civil service commission, EUR, Uncertainty, Eastern Caribbean Central Bank, Abadi, Rest, Reproduction, Fintech, IMF, Federal Reserve, LCR, Data

Key Points:

Digital euro safeguards – protecting financial stability and liquidity in the banking sector

Retrieved on:

Thursday, April 18, 2024

A digital euro would offer a wide range of

Key Points:

A digital euro would offer a wide range of
financial stability benefits, including safeguarding the role of public money and
strengthening the strategic autonomy and monetary sovereignty of the euro area in
the digital era.
Keywords: CBDC, digital euro, bank intermediation, financial stability risks.
A digital euro has the potential to offer a wide range of financial stability
benefits for the digital era.
A digital euro would
stimulate financial innovation among private sector entities and enhance the
efficiency and resilience of the financial system by supporting competition and
diversity within it.3 In addition, a digital euro would strengthen the strategic autonomy
and monetary sovereignty of the euro area.
A digital euro would be designed to minimise risks to the financial system.
2
The preparation phase will pave the way for a future decision on whether or not to issue a digital euro.
When gauging the implications for the euro area banking sector of introducing a
digital euro, take-up would be key, as it would determine the level of deposit
outflows.
In the latter case, the
issuance of a digital euro would not affect banks? balance sheets, since banks would return euro
banknotes to the Eurosystem in exchange for digital euro.
Banknotes and digital euro are two different
types of central bank liability, so a swap between banknotes and digital euro would only affect the
composition and not the size of the Eurosystem?s balance sheet.
In our analysis, we model only the
substitution of commercial bank deposits with a possible future digital euro.
8
The legislative proposal on a digital euro provides for the inclusion of such safeguards and establishes
specific criteria for the limits, aiming to contain the use of a digital euro as a store of value.
ECB Occasional Paper Series No 346
4

2

The added value of digital euro
safeguards such as holding limits
To understand the benefits of digital euro safeguards, such as holding limits, it
is useful to first consider the implications of introducing a CBDC without
adequate safeguards.
(2022), ?Central bank digital currency and bank intermediation: Exploring different
approaches for assessing the effects of a digital euro on euro area banks?, Occasional Papers, No 293,
European Central Bank, Frankfurt am Main, May.
deciding to adopt the digital euro, and (ii) the average amount of digital euro in a
wallet.
At the same time, as discussed in this paper, the design of a digital euro would
include effective safeguards, such as individual holding limits, to mitigate
potential financial stability risks.
ECB Occasional Paper Series No 346
15

an upper bound on the amount of digital euro in circulation, thereby addressing and
limiting financial stability concerns associated with the introduction of a digital euro.
(2023), ?A digital euro: gauging the
financial stability implications?, Financial Stability Review, ECB, November.

Feedback on the input provided by the European Parliament as part of its resolution on the ECB’s Annual Report 2022

Retrieved on:

Thursday, April 18, 2024

Crypto, European banking union, Governance, Exercise, TARGET, Ciccarelli, Single, Climate, OJ, Ethics, Carbon, ECRB, Parliament, Council, European Systemic Risk Board, European Commission, Paris Agreement, Television, Annual, Letter, Speech, Employment, Social, ESRB, Euro, Prejudice, FSB, AML, ECB, Blog, Risk, ESCB, Committee, NGFS, Policy, Woman, Suggestion, Radio, GDP, Privacy, Weather, Person, Climate change, Communication, Digital, Intelligence, Economic and monetary union, SSM, Bias, Knowledge, Mentorship, EMU, Commission, Economy, Publication, Annual report, Financial Action Task Force, Orientation, Nickel, NPL, European Central Bank, Uncertainty, Financial Stability Board, Conference, NCBS, Treaty, Growth, Financial system, Central bank, European Parliament, Network, Natural Resources, COVID-19, Terrorism, Bank, Female, IMF, Multi-function printer, Recreation, Memorandum, Data, AMLA, Security printing

Beyond managing related risks, the financial sector can also contribute to the transition toward a net-zero economy.

Key Points:

Beyond managing related risks, the financial sector can also contribute to the transition toward a net-zero economy.
Our work aims to enhance data transparency in climate change analysis, while informing monetary policy, financial stability and banking supervision.
The indicators we have developed focus on the euro area financial sector and are built from harmonised granular datasets.

EBA, EIOPA and ECB set up a joint governance framework for the collaboration on the DPM 2.0 standard

Retrieved on:

Thursday, April 18, 2024

EBA, Central bank, ECB, Committee, 2.0, EIOPA, Pension, Metadata, DPM, European Central Bank, Real estate

EBA, EIOPA and ECB set up a joint governance framework for the collaboration on the DPM 2.0 standard

Key Points:

EBA, EIOPA and ECB set up a joint governance framework for the collaboration on the DPM 2.0 standard
The European Banking Authority (EBA), the European Insurance and Occupational Pensions Authority (EIOPA) and the European Central Bank (ECB) set up a Data Point Model (DPM) alliance, establishing a common governance framework for the collaboration on the DPM 2.0 Standard.
Following the publication by the EBA and EIOPA of the DPM 2.0 standard in June 2023, the two ESAs together with the ECB have agreed on the common arrangements that will govern their cooperation on DPM 2.0 (the DPM alliance).
Under the DPM alliance, the EBA, EIOPA and ECB will together govern the DPM 2.0 standard and cooperate in the DPM methodology for modelling reporting requirements, the metamodel used for populating the reporting requirements and the associated documentation.
The DPM alliance is established through a Memorandum of Understanding that was signed by the EBA, ECB, and EIOPA.