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Deliverable R&D

Common Technical Document (CTD)

What is a Common Technical Document (CTD)?
The Common Technical Document (CTD) provides a shared format that is accepted by various regulatory bodies including the European Medicines Agency (EMA) in Europe, the Food and Drug Administration (FDA) in the United States, and the Ministry of Health, Labour and Welfare in Japan. It is mandatory to use this format for any new drug applications in Europe and Japan, and is recommended for new drug applications (NDAs) in the United States. This documentation is part of the application when registering a human pharmaceutical product. The guidelines for the CTD were developed under The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and is called the ICH M4 guidelines. The main purpose of the CTD is to provide a common format that reduces the time and resources to complete an application for registration across various jurisdictions. This also simplifies the communication between the applicant and regulatory bodies as the standard format is something that everyone involved is generally familiar with. One of the aims of the CTD is to allow for transparent and clear display of information. The ICH guidance specifies the type of paper it should be printed on, the font, font size, usage of acronyms, and more.

What are the sections of a CTD?
CTDs are divided into five main modules: 1-Administrative and prescribing information, 2-Overview and summary of modules 3 to 5, 3-Quality (pharmaceutical documentation), 4-Non-Clinical reports (Pharmacology/Toxicology), and 5-Clinical study reports (Clinical Trials). Module 1 is not always included in the CTD since the documents from the module are specific to each respective region. Module 2 contains 7 sections and gives an overview of the document with summaries. It introduces the drug stating its pharmacological class, proposed clinical use, and its mechanism of action. Next, it summarizes the quality of information and the Non-Clinical and Clinical overviews. These summaries reflect the information that is presented in the next modules.

Module 3 focuses on aspects including quality, manufacturing, chemistry, and controls reports. This section also includes information on the drug substance and drug product. Module 4 incorporates the non-clinical study reports. These sections are titled pharmacology, pharmacokinetics, and toxicology. This section takes a deep dive into the science behind the drug. Lastly there is Module 5, the clinical study reports. The reports of biopharmaceutic studies, studies pertinent to pharmacokinetics using human biomaterials, human pharmacokinetic studies, human pharmacodynamic studies, efficacy and safety studies, post-marketing experience, case report forms, and individual patient listings are all included in this module.

The use of CTD has significantly improved the application process but there are some discrepancies between countries. For example, the FDA requires submission of an Integrated Summary of Efficacy (ISE) and Integrated Summary of Safety (ISS) which was initially thought to be replaced by the Clinical Summary section of the CTD but persists as a separate requirement. Overall, this document positively impacted the regulatory review processes and created a simpler method of electronic submission. For the pharmaceutical industry, it no longer requires companies to reformat information in applications when submitting to different ICH regulatory authorities.

Who writes CTDs?
CTDs are generally written by medical writing groups in collaboration with broad cross-functional teams which hold expertise in specific elements contained within the document. Regulatory personnel will ensure it meets agency needs and aligns to broader regulatory strategy.