eCTD  Module 2

The International Conference on Harmonisation (ICH) developed the electronic Common Technical Document (eCTD) standard format to facilitate submission of data and information by pharmaceutical companies to regulatory agencies. The eCTD holds information according to sections, documents, and modules such as eCTD Module 2.

MasterControl Registrations for eCTD is a product registration and eCTD management solution designed for pharmaceutical companies seeking FDA drug approval or pursuing marketing authorization application (MAA) in the European Union and other countries. These companies are required to follow the eCTD standard format, including eCTD Module 2, Modules 3, 4, and 5, while Module 1 is region-specific.

Get to Know CTD Module 2

As mentioned above, the CTD is a common five-module format that enables drug manufacturers to demonstrate the quality, safety and efficacy of a drug. CTD Module 2, also referred to as ICH Module 2, is common to all geographies and is basically a set of documentation consisting of seven summaries. The summaries included in the module can be described as follows:

Summary 1: A table of contents representing all CTD modules

Summary 2:An introduction to the drug which includes pharmacological data and other specified details

Summary 3: A “Quality Overall Summary” or QOS which basically provides an overview of Module 3

Summary 4: A nonclinical overview that includes pharmacologic, pharmacokinetic and toxicologic evaluations

Summary 5: A critical assessment of clinical data

Summary 6: A nonclinical written summary (lengthier than summary number four) which includes the same types of data as number four but in more detail and at greater length

Summary 7: A clinical summary that focuses on data summarization and integration. This summary does not include clinical study reports or any raw data from trials

These seven summaries make up the CTD Module 2. Some of them, number six for example, are expected to be quite lengthy and must contain a significant amount of required detail.

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CTD Module Management Made Simple

Drug development and approval is a lengthy and costly process. You’ve got submissions and registrations to manage from start to finish and little room for error. As you consider your own regulatory management processes, ask yourself whether the following are true of your company:

  • Effective Document Management: The processes required to collect and manage regulatory content and data are automated, as is all appropriate documentation (including design concepts, prototypes and design and technical files). The search and retrieval of all documentation is quick and easy.

  • Visibility of Product Registration Projects: All regulatory information is organized by product and geography and is automatically harmonized where applicable.

  • Efficient Repurposing of Content for Submission: All data is searchable by stakeholders and other approved users and each product’s journey to regulatory compliance is clear.

  • Effective Collaboration of Different Teams: The process of compiling, reviewing and approving regulatory documentation is automated. Task distribution, notifications and escalations are automated as well.

  • Improved Milestone Management: Submissions content is simple to repurpose in order to meet regulations associated with a new geography. (The eCTD standard has harmonized the submission process throughout the industry, but pharmaceutical companies often struggle with the massive amount of content that must necessarily be repurposed. Such redundancies and other kinds of duplicated efforts are inevitable for medium and large companies with multiple product lines.)

  • Connectivity Under a Single Platform:Collaboration between teams is integrated and visibility is high among all teams, including the appropriate consultants and vendors.

Automated Regulatory Excellence from MasterControl RIM

  • Improves efficiency by automating the collection and management of regulatory content and data, including design concepts, prototypes and design and technical files

  • Harmonizes regulatory and quality processes for better collaboration and increased productivity

  • Speeds up the search and retrieval of all submissions and/or regulatory documentation

  • Centralizes content and data under one platform for a single source of truth for all stakeholders

  • Enables authorized users, including consultants and contractors, to collaborate in real time

Learn More About MasterControl RIM for eCTD

MasterControl is the software provider for hundreds of life science companies and is trusted by the U.S. Food and Drug Association (FDA) as its preferred quality management software system. For more information about MasterControl RIMs for eCTD, contact one of our representatives.