The Electronic Common Technical Document
01 Jun 2006-International Journal of Pharmaceutical Medicine (Springer International Publishing)-Vol. 20, Iss: 3, pp 149-158
TL;DR: The eCTD has advantages over the CTD in terms of ease of use, archiving and for life-cycle management of registration information, and the technical requirements, the implementation by different countries and the practicalities are discussed.
Abstract: The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Common Technical Document (CTD) format has now become the obligatory format for the EU, Japan, Canada, Switzerland and Australia, and the recommended format in the US. Derivatives of the CTD are becoming widely adopted in other regions, including the ASEAN countries. An electronic CTD (eCTD) was developed in parallel with the CTD and the three ICH regions now accept eCTD filings. The purpose of this article is to survey the eCTD technical requirements, the implementation by different countries and to discuss some of the practicalities involved in writing, compiling and publishing eCTD applications. The eCTD has advantages over the CTD in terms of ease of use, archiving and for life-cycle management of registration information. The eCTD specification defines the folder structure, contents, XML backbone and the Study Tagging File for clinical and nonclinical studies. The design of the eCTD documentation needs to include considerations of document granularity, templates, shell documents and regional differences in filings; for example, the need for an Integrated Summary of Efficacy and Integrated Summary of Safety in the US. Regulatory agencies are moving to accept online filings, but these are currently commonly made using physical media such as CD, DVD or tape. The eCTD file needs to be ‘reviewer friendly’ by use of bookmarks, hyperlinking and tables of contents in individual documents. Prescriber and patient information can now be supplied electronically using the XML-based EU PIM Data Exchange Standard and the Structured Product Labelling in the US. Many commercial software tools are available for content management, assembly, compilation, publishing, labelling, electronic validation and review. eCTDs can be developed using leased or purchased software, specialist contract services, outsourcing from software vendors or using contract research organisations.
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TL;DR: As a postgraduate medical discipline, pharmaceutical medicine has a recognised international syllabus, training courses with examinations and qualifications, its own research methodologies, professional bodies and academic societies, journals and texts, and embraces new technologies and regulations in pursuit of proof of efficacy, safety and effectiveness of medicines.
Abstract: For over 30 years pharmaceutical medicine has developed as a medical scientific discipline for the discovery, development, evaluation, registration, monitoring and medical marketing of medicines for the benefit of patients and community health. Pharmaceutical medicine occupies common ground between the clinical and healthcare professions, pharmaceutical industry and government. While the boundaries of pharmaceutical medicine are indistinct, at its centre is the clinical testing of medicines, translation of drugs into new medicines, safety and well-being of research subjects in clinical trials, and understanding the safety profile of medicines and their benefit-risk balance. Pharmaceutical medicine is a discipline that takes its place alongside other medical specialties; it has developed its own professional ethos; it has established a distinct body of knowledge based primarily on clinical science; and its practitioners represent a cohesive group of specialists with common goals and aspirations. Pharmaceutical physicians work in industry, drug regulatory authorities and clinical research organisations, but have a close affinity with their medical colleagues in primary and secondary healthcare and at universities.As a postgraduate medical discipline, pharmaceutical medicine has a recognised international syllabus, training courses with examinations and qualifications, its own research methodologies, professional bodies and academic societies, journals and texts, and embraces new technologies and regulations in pursuit of proof of efficacy, safety and effectiveness of medicines. Pharmaceutical medicine is a listed medical specialty in the UK, Ireland, Switzerland and Mexico. This official recognition is underlined by the availability of accredited education and training of specialist pharmaceutical physicians and the establishment and maintenance of standards of practice and professionalism in the competency, care and conduct applied to their work and of growing public recognition and accountability.
18 citations
29 Apr 2021
TL;DR: In this article, four key criteria are identified that have enabled labs to reach the post-modern stage, which are insights generation through advanced analytics, automatic communication through machine to machine interfaces, removal of boundaries for an open lab, and novel means of ensuring trust through automatic submissions.
Abstract: The pharmaceutical industry is on the brink of entering into the digital age, yet still suffers from fundamental misconceptions and outdated IT systems that inhibit its progress. Four key criteria are identified that have enabled labs to reach the post-modern stage, which are insights generation through advanced analytics, automatic communication through machine to machine interfaces, removal of boundaries for an open lab, and novel means of ensuring trust through automatic submissions. Further progress in these four areas will enable the pharmaceutical laboratory to enter the digital age. Unfortunately, historical roadblocks in the form of an application-centric mindset have so far stifled progress. However, initiatives that supported other industries on their path into the digital age are introduced and evidences for the benefits of the digital age are provided. These span from advanced analytics, data-centric architecture, metadata supported communication, knowledge assisted submissions, to digital maturity models. It is concluded that executives and lab staff within Pharma needs a transition to a data-centric world view to reap all the benefits of the digital age for faster, better, and cheaper drug development.
3 citations
TL;DR: More than three-quarters of individuals with eCTD experience were able to shorten their total time to approval, and more than 90% of this group was able to demonstrate cost savings relative to paper submissions, regardless of their company kind, size, or number of submissions.
Abstract: The International Conference on Harmonisation’s electronic Common Technical Document (eCTD) endeavors to significantly change the pharmaceutical submission process. After decades of using paper, th...
3 citations
01 Jan 2015
TL;DR: The Common Technical Document (CTD) provides a globally harmonized format that is accepted in many regions, avoiding the need to compile different registration dossiers for different regulatory authorities.
Abstract: The major pharmaceutical market in the world is United States. The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Common. Technical Document (CTD) has become the obligatory format for the EU, Japan, Canada, Switzerland and Australia, and the recommended format in the US. An electronic CTD (ECTD) was developed in parallel with the CTD. Three ICH regions US, Europe and Japan now accept eCTD filings. The ECTD has advantages over the CTD in terms of ease of use, archiving and for life - cycle management of registration information. The ECTD specification defines the folder structure, contents, XML backbone and the Study Tagging File for clinical and nonclinical studies. The design of the ECTD documentation needs to include considerations of document granularity, templates, shell documents and regional differences in filings; for example, the needs for an Integrated Summary of Efficacy and Integrated Summary of Safety in the US. The Common Technical Document (CTD) provides a globally harmonized format that is accepted in many regions, avoiding the need to compile different registration dossiers for different regulatory authorities. It is organized into five modules. Module 1 is region specific, while Modules 2, 3, 4, and 5 are intended to be common for all regions. A regional component is included in Module 3.ECTD format enables pharmaceutical companies to submit applications to various regulatory authorities such as FDA without altering the data. ECTD format is now widely used in the United States, Japan, the European Union and Canada.
30 Sep 2021
TL;DR: In this article, a comprehensive study of the whole CTD and eCTD submission process, as well as the modules that go with it, is presented, focusing on the key regulatory bodies across the world.
Abstract: Regulatory Affairs (RA), also known as government affairs, is a relatively new profession that arose from governments' desire to protect public health by regulating the safety and efficacy of products such as pharmaceuticals, medical devices, pesticides, veterinary medicines, cosmetics, agrochemicals, and complementary medicines. Pharmaceutical regulatory affairs is concerned with the registration of pharmaceutical goods. All regulatory elements and guidelines connected to product filing are summarized in this evaluation. This study covers the whole CTD and eCTD submission process, as well as the modules that go with it. It also focuses on the key regulatory bodies across the world. Various roles of DRA departments, drug regulatory affairs professionals, the importance of drug affairs in pharmacy curriculum, emerging trends affecting regulatory strategy, regulatory affairs in product management, clinical trials, R&D and the drug approval process in the US, EU, and ROW market trends are discussed.
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12 Dec 2001
TL;DR: This draft guidance is intended to provide a guide to the administration's planned implementation of e-cigarettes in the United States and to help states and local authorities better understand the risks and benefits of these products.
Abstract: Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit electronic comments to http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register.
874 citations