Common Technical Document

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

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      authorisation (MA) has been granted or refused or that the MAA has been withdrawn.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

Transform Pharmaceutical Authoring Processes With Fonto Integrated Authoring Platform

Retrieved on: 
Wednesday, March 13, 2024
Software, Pharmaceutical, Finance, Health, Artificial Intelligence, Professional Services, Technology, Apps, Applications, Microsoft, Organization, Documentation, Protocol, CMC, Table, Common Technical Document, RWS, IAP, SPL, Trimethadione, Lead

RWS, a unique, world-leading provider of technology-enabled language, content and intellectual property solutions, announces the launch of the Fonto Integrated Authoring Platform (IAP), a game-changing solution designed to streamline the document creation and publishing process for the pharmaceutical industry.

Key Points: 
  • RWS, a unique, world-leading provider of technology-enabled language, content and intellectual property solutions, announces the launch of the Fonto Integrated Authoring Platform (IAP), a game-changing solution designed to streamline the document creation and publishing process for the pharmaceutical industry.
  • “We’re delighted to announce the availability of Fonto IAP,” explains Jan Benedictus, Managing Director, Fonto.
  • That’s why we’ve introduced Fonto IAP,” according to a Digital Transformation Program Lead at a large pharmaceutical company.
  • Fonto and Tridion are part of RWS’s structured authoring and content management portfolio of solutions.

Electronic Common Technical Document (eCTD) vendor workshop, Online, European Medicines Agency, Amsterdam, the Netherlands, from 27 March 2024, 13:00 (CET) to 27 March 2024, 17:00 (CET)

Retrieved on: 
Wednesday, April 3, 2024
Common Technical Document, Location, EMA, ICH, Architecture

Version 4.0 of eCTD was published in December 2015 with its most recent Implementation Package v1.5 endorsed at the May 2022 ICH meeting.

Key Points: 
  • Version 4.0 of eCTD was published in December 2015 with its most recent Implementation Package v1.5 endorsed at the May 2022 ICH meeting.
  • This session also offers an invaluable opportunity for participants to ask questions and provide feedback on pertinent matters.
  • Registration
    - Registration is open
    After registration you will receive a confirmation e-mail with the link and password to access the workshop.
  • Please make sure to save those to be able to participate to the workshop.

DNAnexus and LORENZ Partner to Enable Collaborative Regulatory Submission Validation and Scientific Review in the Cloud via Trusted Regulatory Spaces

Retrieved on: 
Monday, February 12, 2024
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The regulatory submission process is challenging and resource-intensive for sponsors and health authorities.

Key Points: 
  • The regulatory submission process is challenging and resource-intensive for sponsors and health authorities.
  • Built and powered by DNAnexus, precisionFDA launched in 2015 to enable the advancement of regulatory science and has evolved into a trusted, FedRAMP-authorized platform for secure collaboration and cloud computing.
  • “The regulatory submission and review process is the perfect opportunity to showcase the secure collaboration capabilities of the DNAnexus platform,” said Thomas Laur, CEO of DNAnexus.
  • Both organizations will be available to discuss Trusted Regulatory Spaces at the upcoming DIA RSIDM conference, taking place February 12-14 in Washington, DC.

Product Lifecycle Management (PLM) Value Stream Deep-Dive Webinar, Online, European Medicines Agency, Amsterdam, the Netherlands, from 30 November 2023, 14:00 (CET) to 30 November 2023, 16:00 (CET)

Retrieved on: 
Monday, December 18, 2023
Medicine, Veterinary medicine, Location, Common Technical Document, Learning, RPM, Medical device, PLM, EMA, CET, Agency, Solution, Health, Human, UI, EAF, PMS, Product lifecycle, Technology, Pharmaceutical industry, Information technology, Nursing

PLM is one of three value streams covering the product lifecycle implemented by the Agency as part of its agile transformation.

Key Points: 
  • PLM is one of three value streams covering the product lifecycle implemented by the Agency as part of its agile transformation.
  • PLM aims to digitally transform and optimise regulatory procedure management as well as data submission and reuse throughout the product lifecycle.
  • In addition, further insights into the approach taken to enhance product lifecycle management technology in order enable more efficient and effective medicine regulation will be outlined.
  • Video recording
    Registration
    The registration form is available here:
    Product Lifecycle Management (PLM) Value Stream Deep-Dive Webinar
    Registration will remain open until the start of the webinar.

Two Day Online Development of Combination Pharma Products Training Course: Focus on Critical Interactions - Navigating GMP and Quality in Pharma (February 12-13, 2024) - ResearchAndMarkets.com

Retrieved on: 
Friday, October 27, 2023
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The "Development of Combination Products: Critical Interactions Training Course" conference has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Development of Combination Products: Critical Interactions Training Course" conference has been added to ResearchAndMarkets.com's offering.
  • This program provides valuable insights into crafting an effective regulatory strategy while addressing crucial aspects of Good Manufacturing Practices (GMP) and quality processes.
  • Our interactive seminar serves as a guide to understanding both the European Union (EU) and US approaches to handling drug/device and device/drug combination products.
  • Furthermore, this seminar will emphasize the interconnectedness of quality, regulatory affairs, research and development (R&D), and production functions.

Certara Announces 300th Regulatory Submission Milestone Using its Technology-enabled Services and Software

Retrieved on: 
Tuesday, September 19, 2023
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Certara has supported clients' global regulatory submissions across a wide range of therapeutic areas including cancer, rare diseases, central nervous system (CNS) diseases, and pediatrics.

Key Points: 
  • Certara has supported clients' global regulatory submissions across a wide range of therapeutic areas including cancer, rare diseases, central nervous system (CNS) diseases, and pediatrics.
  • “As the global regulatory drug development environment changes at an ever-increasing pace, Certara has combined regulatory writing expertise with technology platforms that streamline a complex process,” said Demetrius Carter, Sr. Vice President, Regulatory Sciences & Medical Affairs at Certara.
  • In addition to regulatory submission services, Certara offers a software portfolio that saves time and resources in submission development.
  • The software portfolio includes:
    Pinnacle 21™ software used to facilitate all aspects of preparing clinical trial data for regulatory submissions.

Filing eCTD (electronic Common Technical Document) Submissions Training Course: Now Mandatory for Submissions in the EU and Global regulatory Agencies

Retrieved on: 
Friday, August 25, 2023
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Mercia Lucouw works as a regulatory affairs associate at Qdossier, a Celegence company.

Key Points: 
  • Mercia Lucouw works as a regulatory affairs associate at Qdossier, a Celegence company.
  • For ten years she worked as a pharmacist in hospital and has routinely been involved in international clinical trials.
  • After joining Qdossier in 2021, she has been involved several regulatory activities covering a variety of products.
  • She is also part of the development team for DosscriberT (MS word eCTD document templates).

Calyx RIM Successfully Implemented by a Global Market Leading Pharmaceutical Company in FDA's eCTD 4.0 Pilot Program

Retrieved on: 
Tuesday, August 8, 2023
CDER, Clinical data management, Center for Drug Evaluation and Research, Feedback, Center for Biologics Evaluation and Research, RIM, Common Technical Document, Army Network Enterprise Technology Command, FDA, Pharmaceutical industry, Calyx, Research

NOTTINGHAM, England and BILLERICA, Mass., Aug. 8, 2023 /PRNewswire/ -- Calyx, the eClinical and regulatory solutions and services provider relied on for solving complex data challenges in clinical research, today announced a major accomplishment in the evolution of its Regulatory Information Management (RIM) system. Calyx has been successfully used by a global market-leading pharmaceutical company to submit key regulatory information to the FDA during its recently completed electronic common technical document (eCTD) 4.0 implementation pilot program.

Key Points: 
  • Calyx has been successfully used by a global market-leading pharmaceutical company to submit key regulatory information to the FDA during its recently completed electronic common technical document (eCTD) 4.0 implementation pilot program.
  • Calyx clients can rely on Calyx RIM as they adopt eCTD 4.0 as part of their global regulatory processes.
  • "We're proud that the advancements we've made to Calyx RIM enabled this market-leading company to succeed during the pilot program and that all of our clients can rely on Calyx RIM as they adopt eCTD 4.0 as part of their global regulatory processes."
  • Visit calyx.ai/RIM for more information on Calyx RIM and its compliance with evolving global eCTD 4.0 regulations.

Calyx RIM Successfully Implemented by a Global Market Leading Pharmaceutical Company in FDA's eCTD 4.0 Pilot Program

Retrieved on: 
Tuesday, August 8, 2023
CDER, Clinical data management, Center for Drug Evaluation and Research, Feedback, Center for Biologics Evaluation and Research, RIM, Common Technical Document, Army Network Enterprise Technology Command, FDA, Pharmaceutical industry, Calyx, Research

NOTTINGHAM, England and BILLERICA, Mass., Aug. 8, 2023 /PRNewswire/ -- Calyx, the eClinical and regulatory solutions and services provider relied on for solving complex data challenges in clinical research, today announced a major accomplishment in the evolution of its Regulatory Information Management (RIM) system. Calyx has been successfully used by a global market-leading pharmaceutical company to submit key regulatory information to the FDA during its recently completed electronic common technical document (eCTD) 4.0 implementation pilot program.

Key Points: 
  • Calyx has been successfully used by a global market-leading pharmaceutical company to submit key regulatory information to the FDA during its recently completed electronic common technical document (eCTD) 4.0 implementation pilot program.
  • "We worked closely with this leading pharmaceutical company and the FDA during the pilot program to continue advancing Calyx RIM based on ongoing feedback and lessons learned," said Jo English, Vice President and General Manager, Enterprise Technology, Calyx.
  • "We're proud that the advancements we've made to Calyx RIM enabled this market-leading company to succeed during the pilot program and that all of our clients can rely on Calyx RIM as they adopt eCTD 4.0 as part of their global regulatory processes."
  • Visit calyx.ai/RIM for more information on Calyx RIM and its compliance with evolving global eCTD 4.0 regulations.