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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

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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.

Inside Information: Additional Positive Data from the Phase 1 Part of the BEXMAB Study in Both Higher-Risk HMA-Failed MDS and r/r AML

Retrieved on:

Monday, March 18, 2024

TURKU, Finland and BOSTON, March 18, 2024 (GLOBE NEWSWIRE) -- Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company pursuing a CLEVER approach to reprogramming myeloid cells to activate anti-tumor immunity in hematological and solid tumor microenvironments, today provided further data from patients treated during the Phase 1 part of the ongoing BEXMAB trial that has moved into Phase 2 for higher-risk (HR) myelodysplastic syndrome (MDS) patients failed on previous hypomethylating agent (HMA).

Key Points:

Latest readout of the BEXMAB study shows more responding patients and good durability of remission amongst HR HMA-failed MDS patients.
4/5 of the initial Phase 1 HR HMA-failed MDS patients were still alive after eight months of follow-up.
Faron will be hosting a virtual webinar to discuss the additional data tomorrow, Tuesday, 19 March at 11.00 EET/9am GMT.
After the already reported 5 HMA-failed HR MDS patients, 3 new HMA-failed HR MDS patients were enrolled, filling the remaining Phase 1 slots.

PureTech Receives Orphan Drug Designation for LYT-200 in Acute Myeloid Leukemia

Retrieved on:

Wednesday, March 13, 2024

PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the "Company"), a clinical-stage biotherapeutics company dedicated to changing the lives of patients with devastating diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to LYT-200 for the treatment of AML.

Key Points:

PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the "Company"), a clinical-stage biotherapeutics company dedicated to changing the lives of patients with devastating diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to LYT-200 for the treatment of AML.
LYT-200 is a fully human IgG4 monoclonal antibody (mAb) targeting galectin-9, a potent oncogenic driver in leukemia cells and an immunosuppressive protein.
“Orphan drug designation from the FDA validates our belief that targeting galectin-9 with LYT-200 is a novel, promising approach that may offer patients a better tolerated, more effective treatment,” notes Aleksandra Filipovic, MD, PhD, Head of Oncology at PureTech.
The FDA grants orphan drug designation to novel drug and biologic products for the treatment, diagnosis, or prevention of conditions affecting fewer than 200,000 persons in the U.S. Orphan drug designation qualifies PureTech for incentives under the Orphan Drug Act, including tax credits for some clinical trials and eligibility for seven years of market exclusivity in the U.S., if the drug is approved for AML.

Immune-Onc Therapeutics Announces Orphan Drug Designation Granted by US FDA for IO-202 (Anti-LILRB4) for the Treatment of Chronic Myelomonocytic Leukemia (CMML)

Retrieved on:

Wednesday, February 21, 2024

Immune-Onc Therapeutics, Inc. (“Immune-Onc”), a clinical-stage biopharmaceutical company advancing novel therapies in immunology and oncology by targeting myeloid cell inhibitory receptors, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for IO-202 for the treatment of chronic myelomonocytic leukemia (CMML).

Key Points:

Immune-Onc Therapeutics, Inc. (“Immune-Onc”), a clinical-stage biopharmaceutical company advancing novel therapies in immunology and oncology by targeting myeloid cell inhibitory receptors, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for IO-202 for the treatment of chronic myelomonocytic leukemia (CMML).
IO-202 received Fast Track Designation for treatment of relapsed or refractory CMML in 2023.
In addition, Fast Track and Orphan Drug Designations for IO-202 were granted by the FDA for the treatment of acute myeloid leukemia (AML) in 2022 and 2020, respectively.
“We are very proud that the FDA has granted IO-202 Orphan Drug Designation for the treatment of CMML.

Hyundai Pays Tribute to the African American Community in Commemoration of Black History Month

Retrieved on:

Thursday, February 29, 2024

"As we celebrate Black History Month, let us honor the resilience, creativity, and invaluable contributions of Black leaders, innovators, and visionaries throughout history," said Randy Parker, CEO, Hyundai Motor America.

Key Points:

"As we celebrate Black History Month, let us honor the resilience, creativity, and invaluable contributions of Black leaders, innovators, and visionaries throughout history," said Randy Parker, CEO, Hyundai Motor America.
Furthermore, we are committed to championing the voices of the African American community through dedicated financial commitments, strategic sponsorships, and active community engagement, all aimed at collectively shaping a brighter future together."
Hyundai's support to empower future generation of leaders extends beyond Black History Month and is a year-long commitment.
The Progress Project at Hyundai provided financial support to Black-owned business so they can foster growth in their community.

Launch of new HMA-EMA catalogues of real-world data sources and studies

Retrieved on:

Friday, February 16, 2024

PASS, EMA, Methodology, Reusability, RWD, HMA, Interoperability, Findability, Accessibility, Metadata, Patient, Policy, Research

- The catalogue for RWD studies expands and replaces the European Union electronic register of post-authorisationstudies (EU PAS Register®).

Key Points:

- The catalogue for RWD studies expands and replaces the European Union electronic register of post-authorisationstudies (EU PAS Register®).
Using ‘FAIR’ data principles (Findable, Accessible, Interoperable and Reusable), they use an agreed set of metadata to describe and connect data sources to studies.
In addition, search on a wider set of metadata, enhanced view, export and data submission functionalities have been implemented in the catalogues.
Notes
EMA will host a webinar on the catalogues on 4 March 2024 from 10:00 to 12:00 CET.

Multi-stakeholder webinar on the HMA-EMA Catalogues of real-world data sources and studies, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 4 March 2024, 10:00 (CET) to 4 March 2024, 12:00 (CET)

Retrieved on:

Friday, February 16, 2024

Documentation, FAQ, Multi, HMA

Multi-stakeholder webinar on the HMA-EMA Catalogues of real-world data sources and studies

Key Points:

Multi-stakeholder webinar on the HMA-EMA Catalogues of real-world data sources and studies
EventHumanData on medicines
Date
Location
This event will provide an overview of the HMA-EMA Catalogues of real-world data sources and studies including their benefits and significance in regulatory practices.
It will also explain how to use the catalogues, user roles and responsibilities effectively.
The event will also contain a demonstration showcasing key features of the platform and speakers will provide information on supporting documentation, including user guides and FAQs, to optimise the use of the catalogues.
A video recording will be made available after the event.

Draft revised consolidated 3-year work plan for the Methodology Working Party (MWP)

Retrieved on:

Wednesday, February 14, 2024

Real-World Evidence, ACT, Data science, CMD, Toxicity, Budesonide, Paliperidone palmitate, Drug development, E20, RWE, ETF, Human, Pharmacology, Machine learning, Quantitative systems pharmacology, Register, Radiopharmaceutical, Legislation, QST, M12, CAT, Salt, Pharmacoepidemiology, Dasatinib, Algorithm, M13, Azacitidine, Methylphenidate, Clinical trial, Health, M&S, Methodology, PBPK, HMA, Adverse drug reaction, European, CHMP, HTA, Biomarker, Big data, Digoxin, Betahistine, Multi, Therapy, Medication package insert, Simulation, LALA, ADR, US FDA, Language, RWD, Corr, PBBM, WPS, SAWP, Committee, Pharmacovigilance, Peptide, ICH, CPS, Contribution, Good, QSP, Model, Epidemiology, Artificial intelligence, RPS, Research, Reproduction, PRAC, EMA, Health Canada, AI, Cross, Gastrointestinal tract, Paliperidone, Communication, Risk, Melatonin, MWP, CP, Medicine, Patient, Biostatistics, Pharmacokinetics, Oligonucleotide, E21, M14, Q&A, Drug, M15, Medical device

Industry level .................................................................................................. 13

Key Points:

Industry level .................................................................................................. 13
Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
EMA/CHMP/58124/2023

Page 2/14

1.
A reflection paper
(RP) on the clinical pharmacology package for oligonucleotides is a prioritised activity in the MWP work
Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
EMA/CHMP/58124/2023

Page 3/14

plan, and it is envisaged that something similar may be needed for other emerging treatment
modalities (e.g., peptides).
Guideline work led by other working parties
?
Revision of the guideline on the requirements for clinical documentation for orally inhaled
products (CPMP/EWP/4151/00 Rev.
Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
EMA/CHMP/58124/2023
Page 4/14

The planned concept papers (CPs) will formulate problem statements for potential workshops and
subsequent guidance documents will be informed and enriched by the outcome of discussions of
workshops to be held in 2024.
Guideline work led by other working parties and committees
?
Revision of Guidance on the investigation of medicinal products in the term and preterm
neonate (EMEA/536810/2008).
There is a need for
Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
EMA/CHMP/58124/2023
Page 5/14

new guidance in these areas to ensure these novel approaches meet the required evidentiary
standards and facilitate their evaluation.
Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
EMA/CHMP/58124/2023
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?

Revision of Guideline on clinical evaluation of diagnostic agents (CPMP/EWP/1119/98/Rev.
Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
EMA/CHMP/58124/2023
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?

Provide appropriate support to the EU network for generic and hybrid medicines including
product-specific requirements.
Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
EMA/CHMP/58124/2023
Page 8/14

2.3.
?
Cross disciplinary work with Quality Working Party and other stakeholders on physiologically
based biopharmaceutics modelling (PBBM).
Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
EMA/CHMP/58124/2023
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?

In order to support adequate evaluation of all methodology MWP will aim to facilitate an
increase in presence and visibility in relevant committees of methodological expertise from
across the EU network such as CHMP, PRAC, PDCO, CMD(h), ETF and CAT.
Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
EMA/CHMP/58124/2023
Page 10/14

?

Product Specific Bioequivalence Guidelines (PSBGLs) (multiple) in liaison with CMD(h): for
2024, azacitidine, budesonide (LALA GIT), trametinib, dabrafenib, paliperidone palmitate (3M
depot) and melatonin have been prioritised as the next in series for drafting.
Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
EMA/CHMP/58124/2023
Page 11/14

4.2.
?
Cross disciplinary work with Quality Working Party and other stakeholders on PBBM model
assessment.
Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
EMA/CHMP/58124/2023
Page 12/14

?

To deliver an improved access to raw data (e.g.
?
Propose regulatory research priorities for funders in across the activities of Methodology
Working Party, including in the big data area.
?
Establish key communication points in national competent authorities and build a resource of
key messages and communication materials on regulation and methodology.
The timing of workshops may need to be arranged according to the
Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
EMA/CHMP/58124/2023

Page 13/14

specific needs of the guidance ? either before the guidance is finalised to gather views and
expertise; or once it is finalised for training purposes.
Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
EMA/CHMP/58124/2023
Page 14/14

HMA Mortgage Works with Calque to Empower Better Bids with The Trade-In Mortgage

Retrieved on:

Tuesday, February 6, 2024

Residential Building & Real Estate, Construction & Property, Professional Services, Finance, Sale, HMA, Wayne Gretzky, Real estate

HMA Mortgage, a 100% referral-based mortgage company, has partnered with Calque to launch The Trade-In Mortgage™ across 20 states.

Key Points:

HMA Mortgage, a 100% referral-based mortgage company, has partnered with Calque to launch The Trade-In Mortgage™ across 20 states.
As a referral-based business, HMA Mortgage is dedicated to exceptional customer experiences, and The Trade-In Mortgage provides numerous advantages for their borrowers in terms of price and convenience.
“There’s a reason HMA Mortgage has always been a referral-based business; we do right by our people,” said Robert Fillyaw, Managing Partner at HMA Mortgage.
It’s the rare win/win, and the sort of thing HMA Mortgage prides itself on offering.”
“Working with HMA Mortgage to offer The Trade-In Mortgage is a great fit,” said Dan Mugge, chief operating officer at Calque.

Granite’s Grant Road Widening Project Aims to Improve Traffic Flow and Safety in Tucson

Retrieved on:

Wednesday, January 31, 2024

Granite (NYSE:GVA) has been awarded a contract worth approximately $55 million by the City of Tucson to widen Grant Road from Palo Verde to Venice.

Key Points:

Granite (NYSE:GVA) has been awarded a contract worth approximately $55 million by the City of Tucson to widen Grant Road from Palo Verde to Venice.
Project funding will come from the Regional Transportation Authority and is expected to be included in Granite’s first quarter CAP.
“In addition to serving as an anchor project to the Arizona region and local workforce, the project also compliments our vertically integrated business with a need for aggregates and asphalt on the project.” (Photo: Business Wire)
The project involves widening Grant Road to provide six through lanes and a median with left turn lane pockets.
“This multi-phase project will require continuous communication and outreach with the traveling public, local businesses and residents throughout the project,” said Todd Hill, Granite Vice President of Regional Operations.