Common technical document (CTD) and electronic common technical document (eCTD)
- 1. Mohammad Asim +919953194659 COMMON TECHNICAL DOCUMENT (CTD) Substantial documentation and data are required in submissions for import/manufacture and marketing approval of drugs for human use, resulting in large, complex applications. Till date, applicants have used many different approaches in organizing the information and the differences in organization of data in each application has made reviewing more difficult and can also lead to omission of critical data or analyses. Such omissions can result in unnecessary delays in approvals. Thus, a common format of submission will help in overcoming these hurdles. The CTD is a set of specifications for a dossier for the registration of medicines (TGA) CTD is an internationally agreed “well-structured common format” for the organization of the technical requirements that is to be submitted to the regulatory authority as an application for the registration of pharmaceuticals for human use in all three ICH regions (U.S.A., Europe and Japan). In 2000, the 10th Anniversary of ICH, Dr. Caroline Nutley Loew of the Pharmaceutical Research and Manufacturers of America (PhRMA) wrote a report, The Value and Benefits of ICH to Industry, which detailed ICH’s creation, procedures, and guideline development in the areas of safety, efficacy, and quality. Her report anticipated that the CTD would revolutionize the submission procedures for industry’s regulatory staff. Dr. Loew characterized the CTD as “offering potential benefits to industry far greater than any other single ICH topic,” and predicted the CTD would afford significant savings in time and resources as complex multiple submissions were replaced by a single technical dossier submitted in the three ICH regions— 13 facilitating simultaneous submission, approval, and launch of new drugs. In calling the CTD “a topic whose value to industry cannot be underestimated,” Dr. Loew noted that with full incorporation of the CTD and the electronic CTD (eCTD), ICH could turn its sights to disseminating guideline information to non- ICH countries, yielding additional benefits to both regulators and industry. Ten years later and in anticipation of ICH’s 20th Anniversary, the value and benefits of ICH to regulators have been realized.
- 2. Mohammad Asim +919953194659 The primary objective of the ICH is to avoid duplicative animal and human testing and to reach a common understanding of the technical requirements to support the registration process in the three ICH regions. These objectives are achieved through harmonized guidelines and result in a more economical use of human, animal and material resources, as well as the elimination of unnecessary delays in the global development and availability of new medicines, whilst maintaining safeguards on quality, safety and efficacy, and regulatory obligations to protect public health. With the development of the Common Technical Document (CTD), the ICH hopes to accomplish many of its objectives. It is organized into: Module 1: General Information Module 2: CTD summaries Module 3: Quality Module 4: Nonclinical study reports Module 5: Clinical study reports MODULE 1 Administrative information and prescribing information. Document specific to each region. E.g. Application form Proposed label for use in the region
- 3. Mohammad Asim +919953194659 MODULE 3 QUALITY The Quality section of the Common Technical Document (M4Q) provides a harmonized structure and format for presenting CMC (Chemistry, Manufacturing and Controls) information in a registration dossier. Module 3 content 3.1 Module 3 table of contents 3.2 Body of data 3.3 Literature references MODULE 4: NON-CLINICAL STUDY REPORTS Module 4 describes the format and organization of the nonclinical (pharmaco-toxicological) data relevant to the application. 4.2 STUDY REPORTS 4.2.1 Pharmacology 4.2.2 Pharmacokinetics 4.2.3 Toxicology 4.3 literature references MODULE 5: CLINICAL STUDY REPORTS Module 5 describes the format and organization of the clinical data relevant to the application. 5.3.1 Reports of Biopharmaceutical Studies 5.3.2 Reports of Studies Pertinent to Pharmacokinetics Using Human Biomaterials 5.3.3 Reports of Human Pharmacokinetic (PK) Studies 5.3.4 Reports of Human Pharmacodynamic (PD) Studies 5.3.5 Reports of Efficacy and Safety Studies 5.3.6 Reports of Post-Marketing Experience 5.3.7 Case Report Forms and Individual Patient Listings 5.4 literature references
- 4. Mohammad Asim +919953194659 ECTD: ELECTRONIC – CTD Developed by M2 EWG (Multidisciplinary 2 Expert Working Group) of ICH. Paper submission has been replaced by electronic submission. CHARACTERISTICS OF ECTD: 1. Files Referenced in the XML Backbone(s) (Extensible Markup Language) REASONS: a) It manages the large data for the entire submission and for each document within the submission. b) This XML backbone allows the eCTD submission to be viewed via a web browser and can be loaded on a Web server. 2. The file formats that can be included in the eCTD are Portable Document Format (PDF) and XML. However other formats can be used for graphs and images. JPEG PNG GIF -may be used for higher resolution. 3. All eCTD submissions include module 1. ADVANTAGES OF CTD To make the reviewing of each application easier and also to avoid omission of critical data or analyses. Omissions of such data can result in unnecessary delays in approvals. To save time and resources. To facilitate regulatory review and communications. Appropriate format for the data Easy to understand and evaluation of data. SILENT BENEFITS OF THE CTD More “reviewable” applications Complete, well-organized submissions More predictable format More consistent reviews Easier analysis across applications Easier exchange of information Facilitates electronic submissions LIMITATIONS CTD is only a format, it’s not a single dossier with a single content. Legal requirements differ in the different regions. ICH guidelines have not yet harmonized in all requirements. Pharmacopoeias are not harmonized Applicant may have regional preferences.