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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

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Key Points:

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authorisation (MA) has been granted or refused or that the MAA has been withdrawn.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

Valeos Welcomes Dr. Stuart Sweet to Board of Directors

Retrieved on:

Tuesday, April 9, 2024

WASHINGTON, April 9, 2024 /PRNewswire/ -- Valeos, a 501(c)(3) nonprofit organization designed to improve organ transplant outcomes for patients and organ donors through data collaboration, today announced the appointment of Dr. Stuart C. Sweet, MD, PhD to its Board of Directors. Dr. Sweet is the W. McKim Marriott Professor of Pediatrics at Washington University in St. Louis, MO, and served as the 2016-2017 Board President of the Organ Procurement and Transplantation Network (OPTN), the U.S. national transplant system. Dr. Sweet spent more than two decades as the medical director of the pediatric lung transplant program at Washington University School of Medicine in St. Louis and St. Louis Children's Hospital, focusing clinically on pediatric lung transplantation and gaining expertise in organ allocation, clinical outcomes, health policy and the role of information technology in medicine.

Key Points:

"I am honored to join the exceptional team at Valeos and continue my dedication to advancing the U.S. organ transplant system," said Dr. Sweet.
"We're excited to welcome Dr. Sweet to our Board of Directors.
This announcement follows an exciting year for Valeos, which saw its first appointments to its Board of Directors and Advisory Committee this past January.
With the backing of leading figures in healthcare, technology and government, Valeos is committed to building the world's largest de-identified transplant data sandbox.

Through the Municipal DIF Office, Sunset World Group Joins the Blue Heart Campaign for the Prevention of Human Trafficking

Retrieved on:

Friday, April 5, 2024

Crime, Farm, Organ, Tourism, American School (economics), Sunset, Conduct, Energy efficiency, United Nations, Blue Heart, Riviera Maya, Carbon footprint, Code, ECPAT, Multimedia

CANCÚN, Mexico, April 5, 2024 /PRNewswire-PRWeb/ -- At the beginning of March 2024, Sunset World Group contributed with linens, such as sheets and towels, to the municipal DIF office (National System for Integral Family Development) in gratitude for having provided the group's employees with training in the Blue Heart campaign to prevent human trafficking promoted by the United Nations Office for Drugs and Crime through our municipality DIF office. With this exchange Sunset World Group confirms its commitment as a socially responsible company.

Key Points:

With this exchange Sunset World Group confirms its commitment as a socially responsible company.
Blue Heart is a campaign that was launched in 2008 and seeks to raise awareness about the crime of human trafficking and reduce the vulnerability of potential victims by informing the population and encouraging their participation with concrete actions to eradicate it.
Moreover, Sunset World Group also received The Code certificate awarded by the international organization ECPAT that promotes social and business responsibility in the issue of the crime of sexual exploitation.
Sunset World Group is a Mexican family business founded by some of the pioneers of Cancun who helped turn it into the most sought-after tourist destination worldwide.

Heroes Helping Heroes During National Kidney Month

Retrieved on:

Tuesday, March 26, 2024

Friends, First responder, Kidney disease, Prostate cancer, Organ, First, Death, CDC, Breast cancer, Community, Transplant, Firefighter, NFFF, Pharmaceutical industry

EMMITSBURG, Md., March 26, 2024 /PRNewswire/ -- The National Fallen Firefighters Foundation, (NFFF) and its affiliate, the First Responder Center for Excellence (FRCE), are partnering with Kidneys for Communities to empower first responder communities across the country to help fallen firefighters' families and others in the firefighter community who are in need of a lifesaving kidney transplant.

Key Points:

Expand Your Legacy —a campaign developed by NFFF/FRCE and the Knox Company to build awareness among firefighters about the life-changing impact of becoming a living kidney donor — is working with Kidneys for Communities, a national community-directed living kidney donation program, to facilitate living kidney donations that support fallen firefighters' families and members of the firefighting community who are battling end-stage kidney disease.
"It can be difficult to ask a stranger or even friends and family members to donate a kidney.
Meanwhile, the Organ Procurement and Transplantation Network reports that approximately 13 people die each day waiting for a kidney transplant.
We hope this program helps those first responders who need kidneys to receive one and that others can become more educated about becoming a living kidney donor."

National Kidney Foundation Recognizes March as National Kidney Month

Retrieved on:

Thursday, February 29, 2024

NEW YORK, Feb. 29, 2024 /PRNewswire/ -- As March approaches, the National Kidney Foundation (NKF) is gearing up to observe National Kidney Month, a crucial time dedicated to raising awareness about kidney health and chronic kidney disease (CKD). With World Kidney Day falling on Thursday, March 14th, this month holds particular significance in advocating for KIDNEY EQUITY FOR ALL™.

Key Points:

NEW YORK, Feb. 29, 2024 /PRNewswire/ -- As March approaches, the National Kidney Foundation (NKF) is gearing up to observe National Kidney Month, a crucial time dedicated to raising awareness about kidney health and chronic kidney disease (CKD).
With World Kidney Day falling on Thursday, March 14th, this month holds particular significance in advocating for KIDNEY EQUITY FOR ALL™ .
"Despite this, they are exposed to inequities in kidney care including evaluation and obtaining a kidney transplant.
To mark National Kidney Month and World Kidney Day, NKF is highlighting several ways the organization is promoting kidney equity.

Reflection paper on investigation of pharmacokinetics in the obese population - Scientific guideline

Retrieved on:

Wednesday, February 14, 2024

Leptin, PD, Metabolism, Toxicity, Body composition, Ciprofloxacin, Clinical Pharmacokinetics, Water, LBW, Perfusion, LBM, Canadian International Council, AUC, PLOS One, Bariatric surgery, Clopidogrel, CYP, Breast, Health, DNA-binding protein, BMC Public Health, Pharmacology, BMI, CRP, Pharmaceutical Research (journal), Organ, Draft, Guideline, Bypass surgery, WHO, Ageing, INT, Pharmacokinetics, Liver, Bioavailability, Chronic liver disease, Human, Incidence, Committee, Absorption, TBW, Cardiovascular disease, Anatomy, CYP2C19, PBPK, Cmax, Factorization of polynomials, European, Lancet, CHMP, Journal, NASH, Pharmacotherapy, Adipose tissue, Non-alcoholic fatty liver disease, Journal of Clinical Investigation, Medication package insert, Overweight, NPS MedicineWise, Permeability, Benzodiazepine, Meta-analysis, Liver disease, Half-life, Acetylcholine, Ciclosporin, AAG, Kinetics, Midazolam, Kidney, Safety, Biomarker, Clinical Pharmacology & Therapeutics, Peptide, Classification, Hypertension, Metabolic syndrome, Acute coronary syndrome, Insulin resistance, Fatty liver disease, CYP2E1, Lithium, Body mass index, Reproduction, EMA, IBW, Injection, Anker, NCA, Enzyme, Inflammation, Cancer, Weight loss, Gastrointestinal tract, Cardiac output, Public health, Adipokine, CYP2C9, E pluribus unum, Physiology, Agency, Risk, Steroid, Lymph, CYP2D6, BSA, GI, Cytokine, Systematic review, Vaccine

Reflection paper on investigations of pharmacokinetics in

Key Points:

Reflection paper on investigations of pharmacokinetics in
the obese population
Table of contents
1.
References .............................................................................................. 9
Reflection paper on investigations of pharmacokinetics in the obese population
EMA/CHMP/535116/2016

Page 2/12

1.
This is considered
a shortcoming that is potentially compounded by obese patients often being poorly represented in
clinical studies.
The specific aims of this reflection paper are to:
?
describe how the effects of obesity can be investigated during clinical medicinal product
development.
?
provide recommendations on when investigations of the effect of obesity on the PK of a
medicinal product should be particularly considered.
Reflection paper on investigations of pharmacokinetics in the obese population
EMA/CHMP/535116/2016
Page 3/12

?

discuss how to reflect PK (and/or PK/PD) findings in weight/weight-based dosing
recommendations.
Absorption
Reduced rate of absorption linked to locally reduced blood flow (8) is reported for the subcutaneous
and transdermal routes in obese subjects.
Distribution
The distribution of medicinal products is driven by body composition, regional blood flow and binding to
tissue and plasma proteins.
Obese subjects have a larger absolute lean body weight (LBW) as well as fat mass.
The physicochemical properties of a medicinal product (lipophilicity, polarity, molecular size, and
degree of ionization) influence its distribution in the body.
In BMI class III obese
subjects, the blood flow per gram of fat is significantly lower than that observed in class I obese or
lean subjects (4).
Reflection paper on investigations of pharmacokinetics in the obese population
EMA/CHMP/535116/2016
Page 4/12

An increased amount of alpha-1-acid-glycoprotein (AAG), linked to a chronic inflammatory state, is
reported in obese individuals.
Fatty infiltrations are present in the liver for 90% of obese subjects, with the extent of the infiltrations
being proportional to the degree of obesity.
In some cases, in particular for CYP3A4 metabolized medicinal products,
bodyweight normalized clearance can be lower in obese patients (23).
Based on presently available data, it has been suggested that uptake transporters
Reflection paper on investigations of pharmacokinetics in the obese population
EMA/CHMP/535116/2016

Page 5/12

are downregulated while efflux transporters may be upregulated (31).
Platelet hyper-reactivity is also observed,
which can impair the response to anti-platelet medicinal products in obese patients (42, 43).
Reflection paper on investigations of pharmacokinetics in the obese population
EMA/CHMP/535116/2016
Page 6/12

3.

the medicinal product properties and scientific literature indicate that obesity may lead to a
marked effect on elimination and/or distribution or on the PK/PD relationship.
These
models may aid in extrapolating the known efficacy and safety in the non-obese population to the
obese population.
The Pharmacokinetics of the CYP3A Substrate Midazolam in Morbidly Obese Patients
Before and One Year After Bariatric Surgery.
Reflection paper on investigations of pharmacokinetics in the obese population
EMA/CHMP/535116/2016
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41.
Reflection paper on investigations of pharmacokinetics in the obese population
EMA/CHMP/535116/2016
Page 12/12

Medicines360 and DKT WomanCare Announce Strategic Partnership to Expand Access to the Hormonal IUD Avibela™

Retrieved on:

Wednesday, January 31, 2024

"As a global nonprofit pharmaceutical organization dedicated to expanding access to affordable reproductive health products for women, DKT WomanCare is an ideal partner for our organization," said Dr. Andrea Olariu, CEO of Medicines360.

Key Points:

"As a global nonprofit pharmaceutical organization dedicated to expanding access to affordable reproductive health products for women, DKT WomanCare is an ideal partner for our organization," said Dr. Andrea Olariu, CEO of Medicines360.
“DKT WomanCare looks forward to leveraging our global partnerships and commercial relationships to ensure every woman, regardless of income, can access affordable, high-quality contraception.
As the supplier of AVIBELA, Medicines360 will focus on providing quality assurance and regulatory oversight, as well as ensuring sustainable product supply to DKT WomanCare and global procurement agencies.
Together, Medicines360 and DKT WomanCare will meet the growing demand for quality-assured, affordable hormonal IUDs and help build a robust and sustainable global contraceptive market.

Valeos Welcomes Strategic Board Members and Advisors

Retrieved on:

Wednesday, January 31, 2024

WASHINGTON, Jan. 31, 2024 /PRNewswire/ -- Valeos, a newly formed 501(c)(3) nonprofit organization designed to radically improve organ transplant outcomes through shared data, today announced the first appointments to its Board of Directors and Advisory Committee. The strategic coalition of leaders—spanning healthcare, technology and government—share a commitment to saving and extending lives through organ transplantation by championing data utilization, standardizing high-quality care and advocating for equity and accessibility.

Key Points:

Members of the Valeos Board of Directors and Advisory Committee include:
Stephanie Trunzo, SVP & GM at Oracle Heath.
Valeos founders Tristan and Jordan Mace will serve as Co-Chairs of the Board of Directors.
More board members and advisors for Valeos are to come in Q1 2024.
Jordan and I have since dedicated our lives to advancing organ transplant outcomes through shared data, leading to the creation of Valeos," said Tristan Mace, Co-Founder and Executive Chairman of Valeos.

New Post Hoc Analysis from MAVORIC Trial Sheds Light on the Burden of Cutaneous T-Cell Lymphoma on Health-Related Quality of Life

Retrieved on:

Monday, December 11, 2023

Understanding how symptoms impact an individual physically, emotionally as well as in their daily life is critical,” said Susan Thornton, Chief Executive Officer, Cutaneous Lymphoma Foundation and one of the study authors.

Key Points:

Understanding how symptoms impact an individual physically, emotionally as well as in their daily life is critical,” said Susan Thornton, Chief Executive Officer, Cutaneous Lymphoma Foundation and one of the study authors.
Bivariate analysis (t-tests and ANOVA) was used to identify demographic and medical history variables that had a relationship with HRQL.
LASSO (least absolute shrinkage and selection operator) regression analysis was used to identify factors that may drive poor HRQL.
In multivariate analysis, worse HRQL was associated with being younger, female, moderate or severe pruritus and impaired function (as measured by ECOG PS).

New Post Hoc Analysis from MAVORIC Trial Sheds Light on Burden of Cutaneous T-cell Lymphoma on Health-related Quality of Life

Retrieved on:

Monday, December 11, 2023

PRINCETON, N.J., Dec. 11, 2023 /PRNewswire/ -- Kyowa Kirin, Inc., an affiliate of Kyowa Kirin Co., Ltd. (Kyowa Kirin, TSE: 4151), a global specialty pharmaceutical company based in Japan, today announced health-related quality of life (HRQL) findings from a post hoc analysis of the MAVORIC trial in patients with mycosis fungoides (MF) or Sézary syndrome (SS), two subtypes of cutaneous T-cell lymphoma (CTCL). Researchers analyzed baseline data collected prior to initiation of study treatments and found the symptoms of advanced MF/SS affected HRQL across all domains, with poorer HRQL associated with being younger in age, female, having moderate or severe itching, and impaired function as measured by the Eastern Cooperative Oncology Group performance status (ECOG PS).

Key Points:

Understanding how symptoms impact an individual physically, emotionally as well as in their daily life is critical," said Susan Thornton, Chief Executive Officer, Cutaneous Lymphoma Foundation and one of the study authors.
Bivariate analysis (t-tests and ANOVA) was used to identify demographic and medical history variables that had a relationship with HRQL.
LASSO (least absolute shrinkage and selection operator) regression analysis was used to identify factors that may drive poor HRQL.
Researchers concluded that assessing a patient's disease concerns may help guide treatment goals and therapeutic choice.