Abstract
The process of discovering and developing a new product can easily take 10–15 years and can cost a sponsor hundreds of millions of dollars. Yet only about 1 of 10000 potential products is deemed to be safe and effective and therefore eligible for approval [1]. In addition, with the widespread use of improved computer technology, the international public has become increasingly aware of the risks associated with using drugs and biologics. Sponsors and regulatory agencies both are being held accountable for approved marketing of products that are found to have life-threatening consequences once they are used by a large population. As a result of public pressure for improved safety and of industry pressure for regulatory agencies to streamline the approval process, many initiatives have arisen that have driven the need to develop the ability to share safety information in a consistent way on an international level [2].
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References
United States Government Accountability Office Report to Congressional Requesters. New Drug Development: Science, Business, Regulatory, and Intellectual Property Issues Cited as Hampering Drug Development Efforts. November 2006. Available at http://www.gao.gov/new.items/d0749_OnlinePDF.pdf (Accessed 20 February 2008).
Boe, P., Authoring the CTD: Leveraging Granularity, Reusability, and Simplicity. Image Solutions, Inc.; Whippany, NJ. Version 1.0; 2008.
Food and Drug Administration. Milestones in US Food and Drug Law History. Available at http://www.fda.gov/oc/history/default.htm (accessed 20 February 2008).
Zolman, T., An Introduction to eCTD: Electronic Common Technical Documents. Image Solutions, Inc.; Whippany, NJ. Version 1.0; October 2007.
International Conference on Harmonisation (ICH). M4 — Organisation of the Common Technical Document for the Registration of Pharmaceuticals for Human Use. Revision 3; Xanuary 2004. Available at http://www.ich.org/cache/compo/276-254-l.html (Accessed 21 February 2008).
International Conference on Harmonisation (ICH). The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality — M4Q. The Quality Overall Summary of Module 2 and Module 3 Quality. Revision 1, September 2002. Available at http://www.ich.org/cache/compo/276-254-l.html (Accessed 21 February 2008).
International Conference on Harmonisation (ICH). The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Safety — M4S. The Nonclinical Overview and Nonclinical Summaries of Module 2 and Organisation of Module 4. Revision 2, December 2002. Available at http://www.ich.org/cache/compo/276-254-l.html (Accessed 21 February 2008).
International Conference on Harmonisation (ICH). The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Efficacy — M4E. Clinical Overview and Clinical Summary of Module 2 and Module 5 Clinical Study Reports. Revision 1, September 2002. Available at http://www.ich.org/cache/compo/276-254-l.html (Accessed 21 February 2008).
International Conference on Harmonisation (ICH). M2 EWG. Electronic Common Technical Document Specification V 3.2. February 04, 2004. Available at http://estri.ich.org/eCTD/eCTD_Specification_v3_2_OnlinePDF.pdf (Accessed 19 February 2008).
ICH Home Page: Structure of ICH. Available at http://www.ich.org/cache/compo/276-254-l.html (Accessed 20 February 2008).
The ICH Website. Available at http://www.ich.org/cache/compo/276-254-l.html (Accessed 21 February 2008).
FDA Centers for Drug and Biologics Evaluation and Research (CDER and CBER). Guidance for Industry: Providing Regulatory Submissions in Electronic Format — Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications. April 2006. Available at http://www.fda.gov/cder/guidance/7087rev_OnlinePDF.pdf (accessed 21 February 2008).
ISIWriter™ CTD Templates. Copyright Image Solutions, Inc. 2004.
FDA Centers for Drug and Biologics Evaluation and Research (CDER and CBER). Guidance for Industry: Integrated Summaries of Effectiveness and Safety: Location Within the Common Technical Document. Draft, June 2007. Available at http://www.fda.gov/cder/guidance/7621dft_OnlinePDF.pdf (accessed 21 February 2008).
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Boe, P. (2009). Global submissions: The common technical document. In: Wood, L.F., Foote, M. (eds) Targeted Regulatory Writing Techniques: Clinical Documents for Drugs and Biologics. Birkhäuser, Basel. https://doi.org/10.1007/978-3-7643-8362-6_11
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DOI: https://doi.org/10.1007/978-3-7643-8362-6_11
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