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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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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
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Table of contents

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Abbreviations .............................................................................................. 3

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Definitions ................................................................................................... 4

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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.
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Contract Manufacturing Organisation (CMO): shall mean an arrangement under which a

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manufacturer provides upstream manufacturing services under contract on behalf of third-party

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pharmaceutical companies.
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Protected Personal Data (PPD): shall mean any personal data which should be protected from

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disclosure.
?Finalised? shall mean that the marketing
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authorisation (MA) has been granted or refused or that the MAA has been withdrawn.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
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national rules on transparency.
The guidance should be read in conjunction with the relevant applicable
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legislation and case law on transparency and data protection.
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This guidance document is intended to apply to information/documents on medicinal products for

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human use, for which the procedure has been finalised under the national, mutual recognition,

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decentralised and centralised procedures.
Third
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parties shall be informed or consulted as needed depending on respective national and European legal

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frameworks.
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In the following sections, the agreed principles on PD and CCI are presented, including guidance on

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whether such information can be disclosed.
EMA/131365/2024
Page 5/50

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Any information identified as PD or CCI must be subject to a preliminary review by the EMA/NCA prior

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to the possible disclosure of the information/documents.
Principles on the protection of personal data (PD)
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The protection of PD is enshrined in EU legislation; it is a fundamental right of EU citizens.
In
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compliance with the applicable European/national legislation, PD should be anonymised in order to

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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
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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
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defined role or responsibility and it is in the public interest to disclose this data.
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Applicants are advised that non-essential information (e.g., personal address, personal phone number)

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should not be included in the MAA dossier.
The
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confidentiality of records that could identify subjects should be protected, respecting the privacy and

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confidentiality rules in accordance with the applicable regulatory requirement(s).
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The applicant remains responsible for compliance with the relevant legislation in cases where such data

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is inadvertently included in the MAA dossier.
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EMA/NCA applies a risk-based approach to assess which personal data elements need to be removed

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from the information/documents in order to limit the risk of re-identification.
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EMA/NCA applies a risk-based approach to assess which personal data elements need to be removed

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from the information/documents in order to limit the risk of re-identification.
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Any proposal to consider information as commercially confidential should be properly justified by the

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owner of the information.
In this respect, any reference(s) to the risk of that interest being
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undermined should be foreseeable and not purely hypothetical.
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Information that is already in the public domain is not considered to be commercially confidential.
Information on the Quality and Manufacturing of medicines
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A general principle regarding quality and manufacturing information is that detailed information could

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be considered commercially confidential but general information should be disclosed.
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In general, and if not in the public domain, the names of manufacturers or suppliers of the active

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substance or the excipients are considered commercially confidential.
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A general description of the type of test methods used and the appropriateness of the specification is

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not commercially confidential.
General information on the fermentation and purification process
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is not commercially confidential, although details including operating parameters and specific material

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requirements are commercially confidential.
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A general description of the type of test methods used and the appropriateness of the specification is

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not commercially confidential.
In general, the data included in clinical trial study reports is considered to be data that can be
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disclosed once PD has been anonymised.
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In each module, a non-exhaustive list of information that may be considered protected personal data (PPD) or commercially confidential information

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333

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(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.

Proposed FTC Order will Prohibit Telehealth Firm Cerebral from Using or Disclosing Sensitive Data for Advertising Purposes, and Require it to Pay $7 Million

Retrieved on:

Thursday, April 18, 2024

Key Points:

Proposed FTC Order will Prohibit Telehealth Firm Cerebral from Using or Disclosing Sensitive Data for Advertising Purposes, and Require it to Pay $7 Million

Retrieved on:

Thursday, April 18, 2024

The order must be approved by the court before it can go into effect.

Key Points:

The order must be approved by the court before it can go into effect.
“As the Commission’s complaint lays out, Cerebral violated its customers’ privacy by revealing their most sensitive mental health conditions across the Internet and in the mail,” said FTC Chair Lina M. Khan.
“To address this betrayal, the Commission is ordering a first-of-its-kind prohibition that bans Cerebral from using any health information for most advertising purposes."
Cerebral provides online mental health and related services on a negative option basis, which means consumers are automatically charged unless they cancel those services.

Despite promising that consumers could “cancel anytime,” Cerebral required its clients to navigate a complex, multi-step, and often multi-day process to cancel.
The complaint alleges that the company continued to charge consumers while it slow-walked consumers’ cancellation requests, which cost consumers millions in additional charges.
The proposed order, which must be approved by a federal court before it can go into effect, only applies to Cerebral.

The Commission voted 3-0 to refer the complaint against Cerebral and Robertson and a stipulated final order with Cerebral to the Department of Justice for filing.
The DOJ filed the complaint and stipulated order in the U.S. District Court for the Southern District of Florida.

Alcohol Addiction Treatment Firm will be Banned from Disclosing Health Data for Advertising to Settle FTC Charges that It Shared Data Without Consent

Retrieved on:

Friday, April 12, 2024

Key Points:

Alcohol Addiction Treatment Firm will be Banned from Disclosing Health Data for Advertising to Settle FTC Charges that It Shared Data Without Consent

Retrieved on:

Friday, April 12, 2024

The Federal Trade Commission has taken action against an alcohol addiction treatment service for allegedly disclosing users’ personal health data to third-party advertising platforms, including Meta and Google, for advertising without consumer consent, after promising to keep such information confidential.

Key Points:

The Federal Trade Commission has taken action against an alcohol addiction treatment service for allegedly disclosing users’ personal health data to third-party advertising platforms, including Meta and Google, for advertising without consumer consent, after promising to keep such information confidential.
As part of a proposed order settling the FTC allegations, New York-based Monument, Inc. will be banned from disclosing health information for advertising and must obtain users’ affirmative consent before sharing health information with third parties for any other purpose.
“This action continues the FTC’s work to ensure strict limits on how firms handle sensitive health data, rather than putting the onus on consumers to protect themselves,” said Samuel Levine, Director of the FTC’s Bureau of Consumer Protection.
Monument used these pixels and APIs to track “standard” and “custom events,” meaning instances in which consumers interacted with Monument’s website.
If the company is found to have misrepresented its finances, it will be required to pay the full amount.

The Commission voted 3-0 to refer the complaint and stipulated final order to the Department of Justice for filing.
The DOJ filed the complaint and stipulated order in the U.S. District Court for the District of Columbia.

EQS-News: DATAGROUP Gives Positive Outlook for Current Fiscal Year

Retrieved on:

Wednesday, April 10, 2024

At today's Annual General Meeting of DATAGROUP SE at the company's headquarters in Pliezhausen near Stuttgart, 73.1 % of the voting share capital was represented.

Key Points:

At today's Annual General Meeting of DATAGROUP SE at the company's headquarters in Pliezhausen near Stuttgart, 73.1 % of the voting share capital was represented.
"The economic situation remains challenging, but DATAGROUP is excellently positioned and I am therefore optimistic about the future."
DATAGROUP intends to invest EUR 6m in these areas in the current fiscal year and thus lay the foundation for further success and future growth.
Inorganic growth through acquisitions will continue to be an important pillar of success in the current fiscal year.

RM plc: Final Results

Retrieved on:

Wednesday, April 10, 2024

TTS, RM Education, Agility, Growth, Learning, RM, International, Educational technology, School, ERP, Sale, EVO, Consortium, Plan, IP, Assessment, Corporation, Pharmaceutical industry

RM plc (‘RM’), a leading global educational technology (‘EdTech’), digital learning and assessment solution provider, reports its full year results for the year ended 30 November 2023 and outlines its new strategic development programme following a fundamental review of the business by its newly established leadership team.

Key Points:

RM plc (‘RM’), a leading global educational technology (‘EdTech’), digital learning and assessment solution provider, reports its full year results for the year ended 30 November 2023 and outlines its new strategic development programme following a fundamental review of the business by its newly established leadership team.
Strategic Portfolio Roadmap of RM developed IP, products and solutions delivered to accreditors, educators and directly to learners for adjacent solutions.
Continuing operations excludes the results of the RM Integris and RM Finance businesses which were sold on 31 May 2023 and have been included in discontinued operations.
Plans to further simplify group, de-leverage, return to growth, and enrich the RM products and solutions to greater profitability.

Kenorland Minerals Announces Termination of Tanacross Project Earn-in Agreement with Antofagasta PLC and Highlights Exploration Upside at South Taurus

Retrieved on:

Thursday, March 28, 2024

Element, Partnership, Option, Taurus, Copper, Anomaly, IP, Antofagasta plc, Soil, TITAN, Rare-earth element

Kenorland's focus moving forward will be targets which remain completely untested, including South Taurus, which shows strong evidence for a concealed copper system."

Key Points:

Kenorland's focus moving forward will be targets which remain completely untested, including South Taurus, which shows strong evidence for a concealed copper system."
In 2020, the Company completed a systematic soil geochemical grid covering South Taurus as well as East Taurus, West Taurus, and McCord Creek targets.
The Company also completed a TITAN induced polarisation (IP) and magnetotellurics (MT) survey extending 5km across the South Taurus anomaly.
The South Taurus target is ready for drill-testing and Kenorland is actively exploring partnership opportunities for a future drill program.

STIVE ASIA Announces Innovative 'Art Print on Demand' on Its Digital Marketplace

Retrieved on:

Tuesday, March 19, 2024

For art enthusiasts, illustrators, and eco-friendly advocates, Discover STIVE ASIA, the leading creative hub in Southeast Asia is uniting talented artists and sustainability champions through purposeful art.

Key Points:

In 2020, STIVE ASIA emerged as a comprehensive digital asset marketplace, initially focusing on hosting certified and original intellectual properties.
Both creators and users can have access to the digital IP marketplace at STIVE ASIA at no cost.
As a total creative solution platform, STIVE ASIA allows both users and creators to buy and sell Certified Digital IP, design contests for custom projects, and eco-friendly merchandise printed with digital IP.
"Stive Asia Official" for Instagram, and "Stive Asia" for Facebook, Tik Tok and Xiao Hong Shu.

MarketingPulse and eTailingPulse attract 1600 industry professionals

Retrieved on:

Wednesday, March 13, 2024

Themed Envision the Next Level, the conferences featured over 30 sessions, InnoTalks and digital marketing and e-tailing workshops, attracting more than 1600 industry professionals from 20 countries and regions.

Key Points:

Themed Envision the Next Level, the conferences featured over 30 sessions, InnoTalks and digital marketing and e-tailing workshops, attracting more than 1600 industry professionals from 20 countries and regions.
And that is what MarketingPulse and eTailingPulse are about.
Some 80 speakers from across the globe addressed topics ranging from AI marketing, purpose marketing, national trends and K-Pop for marketing.
Industry professionals will be able to access the online MarketingPulse & eTailingPulse platform from tomorrow, 14 March, until 13 April, offering a chance to take advantage of the many features of the platform and revisit the events online.