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.
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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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:
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.