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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
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.

PFAS ‘forever chemicals’: Why EPA set federal drinking water limits for these health-harming contaminants

Retrieved on:

Wednesday, April 10, 2024

The U.S. Environmental Protection Agency now believes there is no safe level for two common PFAS – PFOA and PFOS – in drinking water, and it acknowledges that very low concentrations of other PFAS present human health risks.

Key Points:

The U.S. Environmental Protection Agency now believes there is no safe level for two common PFAS – PFOA and PFOS – in drinking water, and it acknowledges that very low concentrations of other PFAS present human health risks.
The agency issued the first legally enforceable national drinking water standards for five common types of PFAS chemicals, as well as PFAS mixtures, on April 10, 2024.

What exactly are PFAS?

This is a large group of human-made chemicals – currently estimated to be nearly 15,000 individual chemical compounds – that are used widely in consumer products and industry.
They can make products resistant to water, grease and stains and protect against fire.

The short answer is that PFAS are harmful to human health and the environment.
Some of the very same chemical properties that make PFAS attractive in products also mean these chemicals will persist in the environment for generations.
The U.S. Geological Survey estimates common types of PFAS are now in at least 45% of the country’s tap water.

What are the health risks from PFAS exposure?

Research consistently demonstrates that PFAS are associated with a variety of adverse health effects.
A review by a panel of experts looking at research on PFAS toxicity concluded with a high degree of certainty that PFAS contribute to thyroid disease, elevated cholesterol, liver damage, and kidney and testicular cancer.

Additionally, current research suggests that babies exposed prenatally are at higher risk of experiencing obesity, early-onset puberty and reduced fertility later in life.
Collectively, this is a formidable list of diseases and disorders.

Who’s regulating PFAS?

DuPont called it Teflon, which eventually became a household name for its use on nonstick pans.
Decades later, in 1998, Scotchgard maker 3M notified the Environmental Protection Agency that a PFAS chemical was showing up in human blood samples.
At the time, 3M said low levels of the manufactured chemical had been detected in people’s blood as early as the 1970s.
The Agency for Toxic Substances and Disease Registry has a toxicological profile for PFAS.

How can you reduce your PFAS exposure?

The best ways to protect yourself and your family from risks associated with PFAS are to educate yourself about potential sources of exposure.
Products labeled as water- or stain-resistant have a good chance of containing PFAS.
Strategies for monitoring and reporting PFAS contamination vary by location and PFAS source, so the absence of readily available information does not necessarily mean the region is free of PFAS problems.

Kathryn Crawford receives funding from National Institutes of Health and US Geological Survey.

Notable Labs Presents the Design Plan for the PPMP-Enabled Phase 2 Trial with Volasertib for Relapsed/Refractory AML at AACR 2024

Retrieved on:

Tuesday, April 9, 2024

Toxicity, Flow cytometry, Labs, Bone marrow, AML, Patient, Cytarabine, Acute myeloid leukemia, PLK1, AACR, BSA, De novo, Poster, Pharmaceutical industry

“We are very pleased to share more data regarding our clinical program and proprietary platform with the oncology community at AACR 2024.

Key Points:

“We are very pleased to share more data regarding our clinical program and proprietary platform with the oncology community at AACR 2024.
Our clinical program will incorporate the co-development of a companion diagnostic test,” said Thomas Bock, M.D., Chief Executive Officer of Notable.
Notable Labs provided an updated plan for the design of an open label Phase 2 study, including a dose optimization plan aimed at reducing toxicity while maintaining efficacy and an overview of study objectives and endpoints.
These preliminary metrics predict that 32-33% of de novo patients and 25% of R/R AML patients would be predicted to be responders if they were treated with volasertib.

Medicenna Presents Updated Results of Single Agent MDNA11 Anti-tumor Activity from Dose Escalation and Ongoing Dose Expansion of the Phase 1/2 ABILITY-1 Study at the 2024 Annual Meeting of the American Association for Cancer Research (AACR)

Retrieved on:

Tuesday, April 9, 2024

Toxicity, PR, Combination therapy, VLS, MSI-H, PD, LFT, RDE, Duodenal cancer, Patient, Hypertelorism, Radiation, MCC, MDNA, AACR, TSX, DLT, Pancreatic cancer, Safety, Regulatory T cell, Melanoma, Cancer, BCC, NK, Pharmaceutical industry

March 22, 2024) include:

Key Points:

March 22, 2024) include:
Acceptable safety profile: No dose limiting toxicity (DLT) reported and no evidence of vascular leak syndrome (VLS).
A new lymph node lesion developed during a 8-week MDNA11 treatment break (vacation) was treated with a single course of radiotherapy prior to resumption of MDNA11.
A new lymph node lesion developed at week 16 while baseline target and non-target lesions remained stable or decreased.
Monotherapy expansion is continuing to enroll patients with metastatic melanoma, non-melanoma skin cancers (cSCC, MCC, and BCC) and MSI-H/dMMR tumors.

Medicenna Presents Updated Preclinical Data on MDNA113, a First-in-Class, Targeted and Masked Bi-functional anti-PD1-IL2 Superkine, at the 2024 Annual Meeting of the American Association for Cancer Research (AACR)

Retrieved on:

Tuesday, April 9, 2024

TORONTO and HOUSTON, April 09, 2024 (GLOBE NEWSWIRE) -- Medicenna Therapeutics Corp. (“Medicenna” or the “Company”) (TSX: MDNA), a clinical-stage immunotherapy company focused on the development of Superkines, today announced new preclinical data on MDNA113, the Company’s novel T-MASK (Targeted Metallo/protease Activated SuperKine) candidate, an IL-13R⍺2 (Interleukin-13 receptor alpha2) specific superkine featuring unique masking and tumor targeting characteristics, were presented at the 2024 Annual Meeting of the American Association for Cancer Research (AACR) held in San Diego, CA, on April 9th, 2024.

Key Points:

Key findings presented at the conference include:
When not activated, MDNA113 shows reduced IL-2R agonism with no change to PD-1/PDL-1 blockade activity.
MDNA113 selectively binds IL-13R⍺2 positive tumor cells in vitro, and durably accumulates (>7 days) in IL-13R⍺2 positive tumors in mice.
Single neoadjuvant treatment with MDNA113 in a highly invasive orthotopic 4T1.2 breast cancer model significantly increases survival by preventing metastasis.
It will be also available on the Scientific Presentations page of Medicenna’s website following the conclusion of the 2024 Annual Meeting of AACR.

Mural Oncology Presents Preclinical Data for IL-18 and IL-12 Programs at the 2024 American Association for Cancer Research Annual Meeting

Retrieved on:

Tuesday, April 9, 2024

Toxicity, Half-life, Patient, Tumor microenvironment, Observation, Interleukin 18, AACR, Neoplasm, Cancer, Cytokine, Immune system, IL-12, Vaccine

WALTHAM, Mass and DUBLIN, Ireland, April 09, 2024 (GLOBE NEWSWIRE) -- Mural Oncology plc (Nasdaq: MURA), a clinical-stage immuno-oncology company developing novel, investigational engineered cytokine therapies designed to address areas of unmet need for patients with a variety of cancers, today shared poster presentations with pre-clinical data from its Interleukin-18 (IL-18) and IL-12 programs at the American Association for Cancer Research (AACR) annual meeting taking place April 5-10 in San Diego, California. This is the first time Mural has shared findings from either program. The details for the presentations are as follows, and both posters are available at https://www.muraloncology.com/publications/.

Key Points:

Mural’s protein engineering approach is twofold: first, it introduces mutations to IL-18 that are designed to minimally impact the structure while eliminating binding to IL-18BP.
The optimal balance of potency and pharmacokinetic enhancement is still being determined to nominate a lead IL-18 development candidate.
We show that resistance to IL-18BP combined with the drug’s extended half-life leads to a durable immunological effect in preclinical models.
“We believe that by self-assembling the split IL-12 subunits within the tumor microenvironments, we can circumvent native IL-12’s severe toxicities without compromising its efficacy.

Sophos Wins Inaugural Award for Best MSP Solution by SE Labs

Retrieved on:

Tuesday, April 9, 2024

Toxicity, Organization, Attack, Intelligence, Luigi, News, MDR, Security, MSP, Intercept, Risk management

OXFORD, United Kingdom, April 09, 2024 (GLOBE NEWSWIRE) -- Sophos , a global leader of innovative security solutions that defeat cyberattacks, today announced that Sophos Endpoint has won Best Managed Service Provider (MSP) Solution in SE Labs Annual Security Awards 2024 .

Key Points:

OXFORD, United Kingdom, April 09, 2024 (GLOBE NEWSWIRE) -- Sophos , a global leader of innovative security solutions that defeat cyberattacks, today announced that Sophos Endpoint has won Best Managed Service Provider (MSP) Solution in SE Labs Annual Security Awards 2024 .
The SE Labs Annual Security Awards assess security vendors based on a combination of continual public testing, private assessments and feedback from corporate clients.
The first-of-its-kind Best MSP Solution award recognizes the critical role of MSPs as the first line of defense for small- and medium-sized businesses (SMBs) against data breaches, ransomware and other debilitating cyberattacks.
We are thrilled to award Sophos Best MSP Solution, for keeping their MSP and partner community armed with innovative security solutions and intelligence that protect their customers in the ever-evolving threat landscape,” said Simon Edwards, CEO at SE Labs.

Chromocell Issues Letter to Stockholders from Chief Executive Officer

Retrieved on:

Tuesday, April 9, 2024

We transferred $2.2 million in liabilities to Chromocell Corporation in exchange for 2,600 shares of Series C Convertible Redeemable Preferred Stock (“Series C Preferred Stock”).

Key Points:

We transferred $2.2 million in liabilities to Chromocell Corporation in exchange for 2,600 shares of Series C Convertible Redeemable Preferred Stock (“Series C Preferred Stock”).
Our CEO has agreed to further defer a considerable portion of his accrued compensation, affirming the belief in Chromocell’s mission.
We truly feel that our IPO and recent therapeutic development activities have positioned Chromocell for long term growth and success.
I wish to thank you for your support and remain a resource to each of you as we move forward.

ProMIS Neurosciences Publishes in the Journal of Biological Chemistry on the Interaction Between Pathogenic Proteins as a Treatment Target for ALS

Retrieved on:

Tuesday, April 9, 2024

Toxicity, PMN, MSA, Bioorganic chemistry, ALS, Multiple system atrophy, Zebrafish, SOD1, Neuroscience, Journal, Brain cell, TAR, Protein, Biochemistry, PROMIS, Antibody, Therapy, Vaccine

ProMIS is developing antibodies selectively targeting misfolded forms of TDP-43 and SOD1.

Key Points:

ProMIS is developing antibodies selectively targeting misfolded forms of TDP-43 and SOD1.
ALS is a fatal neurodegenerative disease of motor neurons.
“Publication of these data underscores the connection of misfolded proteins and ALS and supports targeting our TDP-43-specific epitope with PMN267 as a potential therapeutic approach,” stated Neil Warma, Chief Executive Officer of ProMIS Neurosciences.
“PMN267 is advancing through preclinical development and is showing promise as a potential treatment for ALS.